Healthy, Ketogenic Dieting
Conditions
Keywords
Ketogenic Diet, Nic's keto diet, Cardiovascular health, Elevated LDL levels
Brief summary
The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
Interventions
OTHERNic's Keto Diet
Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Sponsors
KGK Science Inc.
TRC GEN+ managed by Trans Russian co Cy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open-Label
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provided voluntary, written, informed consent to participate in study 2. Males and females between 30 and 55 years of age 3. BMI between 20.0 to 29.9 kg/m2, inclusive 4. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include: * Non hormonal contraceptives * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner at least 6 months prior to screening 5. Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels 6. Agrees to maintain current level of physical activity throughout the study 7. Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits. 8. Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)
Exclusion criteria
1. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial 2. Women who are menopausal or post-menopausal 3. Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet) 4. Subjects with high TSH level (\>4.5mU/L) or Self reported pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 5. Participants with type I or II Diabetes Mellitus 6. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable. 7. Participants with previous or current pathology of the pancreas 8. Current or history of Gastroesophageal reflux disease (GERD) or any significant disease of the gastrointestinal tract 9. Self reported hypertension or on hypertensives. 10. Significant cardiovascular event in the past 6 months as assessed by the QI. 11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI 12. Gastric bypass surgery 13. Individuals with an autoimmune disease or are immune-compromised 14. Self reported HIV-, Hepatitis B- and/or C-positive diagnosis 15. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months 16. Self reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation 17. Self reported blood/bleeding disorders as per QI 18. Current use of prescribed medications listed in Section 7.3.1 19. Current use of over-the-counter medications, supplements, foods, and/or drinks listed in Section 7.3.2 20. Alcohol or drug abuse within the last 12 months 21. High alcohol intake (\>2 standard drinks per day or \>10 standard drinks per week) 22. Clinically significant abnormal laboratory results at screening as assessed by the QI 23. Metal implants that may affect the DEXA scan results will be assessed on case-by-case basis by the QI 24. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit 25. Participation in a clinical research trial within 30 days of study initiation 26. Individuals who are unable to give informed consent 27. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or may pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | 70 days | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70. |
| Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | 70 days | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70. |
| Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | 140 days | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140. |
| Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | 140 days | The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140. |
| Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet | 70 days | Changes to weight as assessed by BMI was reported at baseline and compared to day 70. |
| Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to weight as assessed by BMI was reported at baseline and compared to day 140. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet. |
| Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet. |
| Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet. |
| Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet. |
| Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet. |
| Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L) |
| Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days | 140 days | The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days. |
| Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet. |
| Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet. |
| Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet. |
| Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet | 70 days | Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet. |
| Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet. |
| Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | 70 days | Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet. |
| Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet. |
| Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet. |
| Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | 70 days | Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet. |
| Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet. |
| Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet. |
| Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | 140 days | Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet. |
| Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L). |
| The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days | 140 days | The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days. |
| Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet | 28 days | Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet. |
| Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet | 56 days | Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet. |
| Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet | 84 days | Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet. |
| Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet | 112 days | Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Pre-emergent and Post-emergent Adverse Events | 140 days | Number of pre-emergent and post-emergent adverse events (AEs) |
| Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet | 70 days | ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded. |
| Change in Heart Rate After 140 Days of Following Nic's Keto Diet | 140 days | Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline. |
| Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet | 140 days | Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet | 140 days | ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded. |
| Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet | 140 days | Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet | 140 days | Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet | 140 days | Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Creatinine After 140 Days of Following Nic's Keto Diet | 140 days | Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | 140 days | Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | 140 days | Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet |
| Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet | 140 days | Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet | 140 days | Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet | 140 days | Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet | 140 days | Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet | 140 days | Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet | 140 days | Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet | 140 days | Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet | 140 days | Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet | 140 days | Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet | 140 days | Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet | 140 days | Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Platelet Count After 140 Days of Following Nic's Keto Diet | 140 days | Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet | 140 days | Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet | 140 days | Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet | 140 days | Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet | 140 days | Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline. |
| Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet | 140 days | Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nic's Keto Diet Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Nic's Keto Diet |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 39.86 years STANDARD_DEVIATION 7.36 |
| Race/Ethnicity, Customized Eastern European White | 4 Participants |
| Race/Ethnicity, Customized South American | 3 Participants |
| Race/Ethnicity, Customized South Asian | 1 Participants |
| Race/Ethnicity, Customized Western European White | 6 Participants |
| Region of Enrollment Canada | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 10 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | -4.41 percentage of body fat | Standard Deviation 4.04 |
Primary
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Time frame: 70 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | -2.25 percentage of body fat | Standard Deviation 2.48 |
Primary
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet | 4.38 percentage of muscle mass | Standard Deviation 4.03 |
Primary
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Time frame: 70 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet | 2.24 percentage of muscle mass | Standard Deviation 2.49 |
Primary
Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet
Changes to weight as assessed by BMI was reported at baseline and compared to day 140.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet | -2.82 kg/m^2 | Standard Deviation 1.49 |
Primary
Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet
Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
Time frame: 70 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet | -1.64 kg/m^2 | Standard Deviation 0.83 |
Secondary
Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | -1.21 mm Hg | Standard Deviation 5.25 |
Secondary
Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | 0.30 mm Hg | Standard Deviation 6.6 |
Secondary
Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | 3.23 mm Hg | Standard Deviation 6.06 |
Secondary
Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | 0.44 mm Hg | Standard Deviation 5.13 |
Secondary
Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Time frame: 70 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | -0.14 mm Hg | Standard Deviation 6.81 |
Secondary
Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | -2.33 mm Hg | Standard Deviation 7.34 |
Secondary
Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet
Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet | -0.06 mmol/L | Standard Deviation 0.37 |
Secondary
Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet
Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet | -0.85 pmol/L | Standard Deviation 0.55 |
Secondary
Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet
Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet | -0.22 percent of Glycosylated Haemoglobin | Standard Deviation 0.18 |
Secondary
Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | 0.10 mmol/L | Standard Deviation 0.38 |
Secondary
Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | 0.15 mmol/L | Standard Deviation 0.27 |
Secondary
Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | -0.04 mmol/L | Standard Deviation 0.27 |
Secondary
Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | 0.01 mmol/L | Standard Deviation 0.28 |
Secondary
Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | 0.02 mmol/L | Standard Deviation 0.32 |
Secondary
Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | 0.99 mmol/L | Standard Deviation 1.17 |
Secondary
Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | 1.02 mmol/L | Standard Deviation 0.94 |
Secondary
Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | 0.89 mmol/L | Standard Deviation 0.84 |
Secondary
Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | 0.93 mmol/L | Standard Deviation 0.87 |
Secondary
Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | 1.16 mmol/L | Standard Deviation 1.12 |
Secondary
Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet | -3.85 mm Hg | Standard Deviation 7.58 |
Secondary
Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet | -6.52 mm Hg | Standard Deviation 9.53 |
Secondary
Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet | 1.23 mm Hg | Standard Deviation 7.79 |
Secondary
Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet | -3.06 mm Hg | Standard Deviation 6.62 |
Secondary
Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Time frame: 70 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet | -3.72 mm Hg | Standard Deviation 7.96 |
Secondary
Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet | -2.73 mm Hg | Standard Deviation 8.3 |
Secondary
Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet | 1.01 mmol/L | Standard Deviation 1.31 |
Secondary
Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet | 1.06 mmol/L | Standard Deviation 1.1 |
Secondary
Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L)
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet | 0.87 mmol/L | Standard Deviation 1.01 |
Secondary
Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet | 0.91 mmol/L | Standard Deviation 0.97 |
Secondary
Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet | 1.13 mmol/L | Standard Deviation 1.21 |
Secondary
Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet | -0.16 mmol/L | Standard Deviation 0.55 |
Secondary
Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet | -0.23 mmol/L | Standard Deviation 0.41 |
Secondary
Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet
Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet | 0.04 mmol/L | Standard Deviation 0.62 |
Secondary
Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet | -0.07 mmol/L | Standard Deviation 0.67 |
Secondary
Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet | -0.11 mmol/L | Standard Deviation 0.57 |
Secondary
Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.
Time frame: 112 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet | -6.43 kg | Standard Deviation 3.93 |
Secondary
Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet
Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet | -8.55 kg | Standard Deviation 4.74 |
Secondary
Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.
Time frame: 28 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet | -3.02 kg | Standard Deviation 2.09 |
Secondary
Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.
Time frame: 56 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet | -4.47 kg | Standard Deviation 2.79 |
Secondary
Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet
Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.
Time frame: 70 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet | -4.90 kg | Standard Deviation 2.66 |
Secondary
Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.
Time frame: 84 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet | -5.58 kg | Standard Deviation 3.07 |
Secondary
The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days
The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days | -0.71 mg/L | Standard Deviation 2.1 |
Secondary
The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days
The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days | 0.36 mm/hr | Standard Deviation 4.43 |
Other Pre-specified
Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet
Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet | -1.01 U/L | Standard Deviation 7.82 |
Other Pre-specified
Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet
Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet | 0.00 x10^9 basophils/L | Standard Deviation 0.04 |
Other Pre-specified
Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet
Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet | 0.00 x10^9 eosinophils/L | Standard Deviation 0.08 |
Other Pre-specified
Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet
Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet | -0.17 x10^9 lymphocytes/L | Standard Deviation 0.47 |
Other Pre-specified
Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet
Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet | -0.06 x10^9 monocytes/L | Standard Deviation 0.14 |
Other Pre-specified
Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet
Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet | -0.53 x10^9 neutrophils/L | Standard Deviation 1.21 |
Other Pre-specified
Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet
Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet | 0.08 U/L | Standard Deviation 6.95 |
Other Pre-specified
Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet
Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet | -2.82 kg/m^2 | Standard Deviation 1.49 |
Other Pre-specified
Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet | -0.23 mmol/L | Standard Deviation 1.92 |
Other Pre-specified
Change in Creatinine After 140 Days of Following Nic's Keto Diet
Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Creatinine After 140 Days of Following Nic's Keto Diet | 3.77 µmol/L | Standard Deviation 9.58 |
Other Pre-specified
Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet
Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet | -5.00 mL/min/1.73m^2 | Standard Deviation 11.08 |
Other Pre-specified
Change in Heart Rate After 140 Days of Following Nic's Keto Diet
Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Heart Rate After 140 Days of Following Nic's Keto Diet | 0.61 bpm | Standard Deviation 9.06 |
Other Pre-specified
Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet
Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet | 0.00 l/l | Standard Deviation 0.02 |
Other Pre-specified
Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet
Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet | -1.46 g/L | Standard Deviation 6.31 |
Other Pre-specified
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet
Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet | -3.69 g/L | Standard Deviation 7.48 |
Other Pre-specified
Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet
Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet | -0.08 pg | Standard Deviation 0.95 |
Other Pre-specified
Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet
Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet | 0.85 fl | Standard Deviation 1.41 |
Other Pre-specified
Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet
Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet | -0.20 fl | Standard Deviation 0.26 |
Other Pre-specified
Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet | 0.14 mmol/L | Standard Deviation 0.16 |
Other Pre-specified
Change in Platelet Count After 140 Days of Following Nic's Keto Diet
Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Platelet Count After 140 Days of Following Nic's Keto Diet | 15.85 x10^9 platelets/L | Standard Deviation 30.56 |
Other Pre-specified
Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | -0.12 mmol/L | Standard Deviation 0.46 |
Other Pre-specified
Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet
Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet | -0.05 x10^12 RBC/L | Standard Deviation 0.2 |
Other Pre-specified
Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet
Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet | 0.37 percentage of variation | Standard Deviation 0.71 |
Other Pre-specified
Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet | 0.92 mmol/L | Standard Deviation 2.33 |
Other Pre-specified
Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet
Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.
Time frame: 140 days
Population: The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nic's Keto Diet | Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet | 0.23 µmol/L | Standard Deviation 5.63 |
Other Pre-specified
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet
ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Time frame: 140 days
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nic's Keto Diet | Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet | 0 participants |
Other Pre-specified
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet
ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Time frame: 70 days
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nic's Keto Diet | Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet | 0 participants |
Other Pre-specified
Number of Pre-emergent and Post-emergent Adverse Events
Number of pre-emergent and post-emergent adverse events (AEs)
Time frame: 140 days
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nic's Keto Diet | Number of Pre-emergent and Post-emergent Adverse Events | 44 events |