Overweight
Conditions
Keywords
protein, fiber, weight loss, fat loss
Brief summary
The objective of this study is to investigate the effect of a high protein, high fiber dietary supplement on weight and fat loss in healthy overweight adults. Half of participants will receive a high protein, high fiber supplement twice a day for 12 weeks, and half of the subjects will receive a placebo (that contains the same amount of calories as the supplement) twice a day for 12 weeks.
Interventions
DIETARY_SUPPLEMENTHigh protein, high fiber dietary supplement
Dry powder to be mixed with 10 ounces of cold water
DIETARY_SUPPLEMENTPlacebo
Dry powder to be mixed with 10 ounces of cold water
Sponsors
KGK Science Inc.
Glycemic Index Laboratories, Inc
MB Clinical Research and Consulting LLC
Beachbody
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female of 25-50 years of age 2. If female, the subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result at screening. Acceptable methods of birth control include: * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) for at least 3 months * Double-barrier method * Non-hormonal IUDs * Hormonal IUD methods must be a stable dose for at least 3 months * Vasectomy of partner * Non-heterosexual lifestyle 3. A BMI between 27.0 - \<35.0 kg/m2 (inclusive). Subjects must meet exactly the inclusion BMI at screening, or be screen failed. Subjects who meet the BMI requirement at screening and present at run-in with a BMI of \<27.0 or \>35 kg/m2 will be counselled. 4. Subjects that have had a stable weight for the past 6 months. A stable weight is defined as not having gained or lost more than 5 kg of body weight throughout the past 6 months (cycling of weight, for example, continuously up and down anything less than 5 kg is considered stable) 5. Agreement to comply with dietary recommendations from nutritionist throughout the duration of the study that include a 500 kcal energy deficit from their predicted total energy requirements 6. Agrees to fully comply with all study procedures 7. Has given voluntary written and informed consent to participate in the study 8. Determined to be healthy as per laboratory parameters and physical examination
Exclusion criteria
1. Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study 2. Subjects who are smokers (tobacco, e-cigarettes) or have been a smoker within the past 1 year from screening 3. Individuals who carry an epi-pen, or those with a diagnosed allergy or who believe that they have an allergy to milk or milk products, crustacean shellfish, tree nuts, or peanuts 4. Individuals with a severe allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients 5. The use of prescription, over-the-counter health products, or natural health products/dietary supplements being taken for weight loss, cholesterol levels, or blood pressure within 4 weeks of screening 6. Subjects with a history of eating disorders 7. Current participation or participation within the last 3 months in any weight loss program or diet (for example Weight Watchers, Jenny Craig, DASH diet, Atkins, Mediterranean etc.) 8. Medical history of thyroid disorders except for subjects diagnosed with hypothyroid and have been on stable medication for at least the last 3 months prior to enrollment. All subject with medical history of hyperthyroid are excluded 9. Medical history of hypercholesterolipidemia 10. Use of cholesterol lowering prescription drugs within the last 6 months 11. Fasting TGs ≥ 200 mg/dL (2.26 mmol/L) or a fasting total cholesterol ≥ 240 mg/dL (6.216 mmol/L) 12. Fasting glucose ≥ 126 mg/dL 13. Hypertension defined as untreated systolic blood pressure \>160 mmHg, diastolic blood pressure \>100 mmHg, or the use of prescription high blood pressure/hypertension medications within the last 6 months 14. Type I or Type II diabetes or use of diabetes medication in a preventative setting. 15. History of gastrointestinal dysfunction or surgery that may influence digestion or absorption 16. Chronic inflammation or structural abnormality, including history of, of the digestive tract (inflammatory bowel disease, celiac disease, chronic diarrhea, chronic constipation, duodenal or gastric ulcer, gastric retention or obstruction, Gastroesophageal reflux disease (GERD), or symptomatic cholelithiasis) 17. Subjects who have a history of colorectal cancer, bowel resection, rectocele, or colostomy 18. Immunocompromised individuals such as subjects that have undergone organ transplantation, those with rheumatoid arthritis, or subjects diagnosed with human immunodeficiency virus (HIV) 19. Unstable medical conditions that in the opinion of the Qualified Investigator preclude the subject from participating in the study 20. Anti-anxiety and anti-psychotic medications will be assessed by the MD on a case by case basis 21. Alcohol use \> 2 standard alcoholic drinks per day 22. Alcohol or drug abuse within the last 6 months 23. Use of medicinal marijuana 24. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative 25. Subjects with metal fixation plates or screws from a previous surgery 26. Clinically significant abnormal laboratory results at screening 27. Participation in a clinical research trial within 30 days prior to randomization 28. Allergy or sensitivity to study supplement ingredients 29. Individuals who are cognitively impaired and/or who are unable to give informed consent 30. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject 31. Unwilling or unable to comply with study timeline and procedures 32. Individuals who do not like the taste of chocolate or shake type drinks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight (kg) | Baseline and 12 weeks | Body weight measured by clinic study staff at required visits |
| Change in body fat percentage (%) | Baseline and 12 weeks | Body fat percentage as determined by dual x-ray absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent trunk fat (%) | Baseline and 12 weeks | Trunk fat percentage as determined by DXA |
| Change in Hip circumference (cm) | Baseline and 4 weeks | measured with a tape measure around the greater trochanteric prominence (the widest part of the hips) |
| Change in Waist to hip ratio | Baseline and 4 weeks | Ratio of waist circumference to hip circumference |
| Change in Blood leptin (ng/mL) | Baseline and 12 weeks | Fasting level of leptin in the blood |
| Change in Blood adiponectin (mcg/mL) | Baseline and 12 weeks | Fasting level of adiponectin in the blood |
| Change in Total cholesterol (mg/dL) | Baseline and 4 weeks | Fasting level of total cholesterol in blood |
| Change in low-density lipoprotein (LDL) Cholesterol (mg/dL) | Baseline and 4 weeks | Fasting level of LDL cholesterol in blood |
| Change in high-density lipoprotein (HDL) Cholesterol (mg/dL) | Baseline and 4 weeks | Fasting level of HDL cholesterol in blood |
| Change in oxidized LDL (Ox-LDL) Cholesterol (U/L) | Baseline and 4 weeks | Fasting level of Ox-LDL cholesterol in blood |
| Change in triglycerides (mg/dL) | Baseline and 4 weeks | Fasting level of triglycerides in blood |
| Change in Insulin (IU) | Baseline and 4 weeks | Fasting level of insulin in blood |
| Change in Glucose (mmol/L) | Baseline and 4 weeks | Fasting level of glucose in blood |
| Change in blood glycated haemoglobin (HbA1c) (mmol/mol) | Baseline and 12 weeks | Fasting level of HbA1c in blood |
| Change in gut microbiota composition | Baseline and 12 weeks | Genera of bacteria measured in stool samples |
| Change in total fat mass (kg) | Baseline and 12 weeks | Body fat mass as determined by DXA |
| Change in total lean mass (kg) | Baseline and 12 weeks | Body lean mass as determined by DXA |
| Change in percent abdominal fat (%) | Baseline and 12 weeks | Abdominal fat percentage as determined by DXA |
| Change in percent android fat (%) | Baseline and 12 weeks | Android fat percentage as determined by DXA |
| Change in percent gynoid fat (%) | Baseline and 12 weeks | Gynoid fat percentage as determined by DXA |
| Change in percent leg fat (%) | Baseline and 12 weeks | Leg fat percentage as determined by DXA |
| Change in body weight (kg) | Baseline and 4 weeks | Body weight measured by clinic study staff at required visits |
| Change in Waist circumference (cm) | Baseline and 4 weeks | measured with a tape measure at the part of the trunk located midway between the lower costal margin and the iliac crest while the person is standing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | Baseline and 4 weeks | Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart |
| Change in Profiles of Mood States (POMS) questionnaire ratings | Baseline and 4 weeks | Scores for energy, mood, and stress as assessed by POMS questionnaire |
| Change in Three-factor Eating Questionnaire (TFEQ) scores | Baseline and 4 weeks | Scores for eating behavior as assessed by TFEQ |
| Change in Binge Eating Scale (BES) scores | Baseline and 4 weeks | Scores for binge eating as assessed by BES |
| Change in number of junk food cravings reported | Baseline and 4 weeks | Number of cravings as assessed by daily entries in study diary |
| Change in IgG levels | Baseline and 12 weeks | Fasting level of IgG in blood |
| Change in IgA levels | Baseline and 12 weeks | Fasting level of IgA in blood |
| Change in IgM levels | Baseline and 12 weeks | Fasting level of IgM in blood |
| Change in Complement C3 levels | Baseline and 12 weeks | Fasting level of C3 in blood |
| Change in Complement C4 levels | Baseline and 12 weeks | Fasting level of C4 in blood |
| Change in systolic blood pressure | Baseline and 4 weeks | Seated resting blood pressure will be determined from 3 measurements obtained at least 1 minute apart |
| Change in Bowel Habits (number of bowel movements/day; Bristol Stool form type) | Baseline and 4 weeks | Bowel habits assessed for 72-hour period every 2 weeks by bowel habits diary including number of bowel movements per day and classification of stool form type. Data for each time point (4, 8, and 12 weeks) will include 2 diary collections. |
| Change in Modified Gastrointestinal Symptoms Rating Scale (GSRS) dimensions | Baseline and 4 weeks | Score on each of the 6 dimensions contained in the validated Modified GSRS tool (scores 1-7) |
Countries
Canada, United States
Outcome results
None listed