Postprandial Glycemic Control, Prediabetic Overweight and Obese Adults
Conditions
Keywords
prediabetic overweight and obese adults, postprandial glycemic control, Lembas
Brief summary
The goal of part 1 of this clinical trial is to investigate the tolerability of Lembas Edge in healthy adults. The objective of Part 2 of this study is to investigate the efficacy of Lembas Edge on postprandial glycemic control in prediabetic overweight and obese adults. The main questions it aims to answer are: * What is the tolerability of Lembas Edge? * What is the efficacy of Lembas Edge on postprandial glycemic control? Researchers will compare Lembas Edge to placebo to see its effects. Participants will be asked to: * Provide blood samples. * Record their food and beverage intake in Part 2. * Complete a satiety questionnaire in Part 2. * Consume Lembas Edge or placebo as instructed.
Interventions
DIETARY_SUPPLEMENTLow dose alpha-galactosidase-derived peptide
Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
DIETARY_SUPPLEMENTMedium dose alpha-galactosidase-derived peptide
Participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
DIETARY_SUPPLEMENTHigh dose alpha-galactosidase-derived peptide
In part 1, participants will be instructed to take 3 capsules daily (as a single dose) in the morning until the day prior to their end of study visit (Day 13). In part 2, participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
DIETARY_SUPPLEMENTPlacebo
In part 1, participants will be instructed to take 3 capsules daily (as a single dose) in the morning until the day prior to their end of study visit (Day 13). In part 2, participants will be instructed to take 3 capsules of the study product in a fasted state 120 minutes before a standardized breakfast.
Sponsors
Lembas
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part 1: Open-label & Part 2: Triple-blind
Intervention model description
Part 1: Single-arm, open-label & Part 2: Randomized, triple-blind, placebo controlled, cross over
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Part 1: 1. Males \& females 18 years and older 2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals 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. All hormonal birth control must have been in use for a minimum of three months. 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) * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner at least 6 months prior to screening * Abstinence and agrees to use contraception if planning on becoming sexually active during the study 3. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 4. Provided voluntary, written, informed consent to participate in the study 5. Healthy as determined by medical history as assessed by the Qualified Investigator (QI) Inclusion Criteria Part 2: 1. Males \& females 18 years and older 2. Body Mass Index (BMI) between 25.0 and 34.9 kg/m2 3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals 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. All hormonal birth control must have been in use for a minimum of three months. 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) * Double-barrier method * Intrauterine devices * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s) * Vasectomy of partner at least 6 months prior to screening * Abstinence and agrees to use contraception if planning on becoming sexually active during the study 4. Hemoglobin A1c (HbA1c) of 5.7-6.4% at screening 5. Willingness to complete questionnaires, records and diaries associated with the study and to complete clinic visits 6. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 7. Provided voluntary, written, informed consent to participate in the study 8. Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Exclusion criteria
Part 1: 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy (including alpha-gal syndrome), sensitivity, intolerance, or dietary restriction preventing consumption of investigational product 3. Unstable metabolic disease or chronic diseases as assessed by the QI 4. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI 5. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3) 6. Type I or Type II diabetes 7. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis 8. 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 in participants who are symptom free for 6 months 9. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 10. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI 11. Cancer, except skin basal cell carcinoma 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 12. Individuals with an autoimmune disease or are immune compromised as assessed by the QI 13. Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI 14. Self-reported confirmation of blood/bleeding disorders as assessed by the QI 15. Use of prescribed medical cannabinoid products 16. Chronic use of cannabinoid products (\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period 17. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period 18. Alcohol intake average of \>2 standard drinks per day as assessed by the QI 19. Alcohol or drug abuse within the last 12 months 20. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the safety of the investigational product (Sections 7.3.1 and 7.3.2) 21. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 22. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI 23. Individuals who are unable to give informed consent 24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Day 0 to 14 | Part 1. Incidence of post-emergent adverse events (AE) |
| Clinically relevant changes in blood pressure after supplementation | Day 0 to 14 | Part 1. Clinically relevant changes in blood pressure (mmHg) after supplementation |
| Clinically relevant changes in heart rate after supplementation | Day 0 to 14 | Part 1. Clinically relevant changes in heart rate (beats per minute) after supplementation |
| Clinically relevant changes in aspartate aminotransferase | Day 0 to 14 | Part 1. Clinically relevant changes in aspartate aminotransferase (U/L) after supplementation. |
| Clinically relevant changes in alanine aminotransferase | Day 0 to 14 | Part 1. Clinically relevant changes in alanine aminotransferase (U/L) after supplementation. |
| Clinically relevant changes in alkaline phosphatase | Day 0 to 14 | Part 1. Clinically relevant changes in alkaline phosphatase (U/L) after supplementation. |
| Clinically relevant changes in total bilirubin | Day 0 to 14 | Part 1. Clinically relevant changes in total bilirubin (micromole/litre) after supplementation. |
| Clinically relevant changes in creatinine | Day 0 to 14 | Part 1. Clinically relevant changes in creatinine (micromole/litre) after supplementation. |
| Clinically relevant changes in sodium | Day 0 to 14 | Part 1. Clinically relevant changes in sodium (mmol/L) after supplementation. |
| Clinically relevant changes in potassium | Day 0 to 14 | Part 1. Clinically relevant changes in potassium (mmol/L) after supplementation. |
| Clinically relevant changes in chloride | Day 0 to 14 | Part 1. Clinically relevant changes in chloride (mmol/L) after supplementation. |
| Clinically relevant changes in estimated glomerular filtration rate | Day 0 to 14 | Part 1. Clinically relevant changes in estimated glomerular filltration rate (mL/min/1.73 m\^2) after supplementation. |
| Clinically relevant changes in glucose | Day 0 to 14 | Part 1. Clinically relevant changes in glucose (mmol/L) after supplementation. |
| Clinically relevant changes in red blood cell count | Day 0 to 14 | Part 1. Clinically relevant changes in red blood cell count (x 10\^12/L) after supplementation |
| Clinically relevant changes in white blood cell count | Day 0 to 14 | Part 1. Clinically relevant changes in white blood cell count (x 10\^9/L) after supplementation |
| Clinically relevant changes in platelet count | Day 0 to 14 | Part 1. Clinically relevant changes in platelet count (x 10\^9/L) after supplementation |
| Clinically relevant changes in hemoglobin | Day 0 to 14 | Part 1. Clinically relevant changes in hemoglobin (g/L) after supplementation |
| Clinically relevant changes in hematocrit | Day 0 to 14 | Part 1. Clinically relevant changes in hematocrit (L/L) after supplementation |
| Clinically relevant changes in red blood cell indices (MCV - Mean Corpuscular Volume) | Day 0 to 14 | Part 1. Clinically relevant changes in MCV (fL) after supplementation |
| Clinically relevant changes in red blood cell indices (MCH - Mean Corpuscular Hemoglobin) | Day 0 to 14 | Part 1. Clinically relevant changes in MCH (pg) after supplementation |
| Clinically relevant changes in red blood cell indices (MCHC - Mean Corpuscular Hemoglobin Concentration) | Day 0 to 14 | Part 1. Clinically relevant changes in MCHC (g/L) after supplementation |
| Clinically relevant changes in RDW - Red Cell Distribution Width | Day 0 to 14 | Part 1. Clinically relevant changes in RDW (%) after supplementation |
| Clinically relevant changes in red blood cell indices (MPV - Mean Platelet Volume) | Day 0 to 14 | Part 1. Clinically relevant changes in MPV (fL) after supplementation |
| The difference in postprandial glucose between Lembas Edge and placebo | Visit 2 (day 1) to Visit 5 (day 22) | Part 2. The difference in postprandial glucose, as assessed by incremental area under the curve (iAUC) (0-120 min), between Lembas Edge (high dose, medium dose, low dose) and placebo. |
| The height of the postprandial glucose peak and nadir post meal between Lembas Edge and placebo | Visit 2 (day 1) to Visit 5 (day 22) | Part 2. The height of the postprandial glucose peak and nadir post meal between Lembas Edge (high dose, medium dose, low dose) and placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in postprandial glucose iAUC (0-240 min) between Lembas Edge and placebo | Visit 2 (day 1) to Visit 5 (day 22) | Part 2. The difference in postprandial glucose, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo |
| The difference in postprandial insulin between Lembas Edge and placebo | Visit 2 (day 1) to Visit 5 (day 22) | Part 2. The difference in postprandial insulin, as assessed by iAUC (0-120 min) and iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo |
| The difference in self-reported satiety scores between Lembas Edge and placebo | Visit 2 (day 1) to Visit 5 (day 22) | Part 2. The difference in self-reported satiety scores, as assessed by iAUC (0-240 min), between Lembas Edge (high dose, medium dose, low dose) and placebo |
Countries
Canada
Contacts
CONTACTErin Lewis
Outcome results
None listed