PreDiabetes
Conditions
Brief summary
This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.
Interventions
DIETARY_SUPPLEMENTN-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (\>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products.
DIETARY_SUPPLEMENTPlacebo Control
Placebo Control
Sponsors
Brightseed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Fasting Blood Glucose between 100-125 mg/dL; 2. and BMI range 25-30 kg/m2; 3. and waist circumference ≥80cm for women and ≥90cm for men;
Exclusion criteria
1. Weight loss or gain ≥4.5 kg within 90 days of visit 1. 2. Use of weight loss medications within 90 days of visit 1. 3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes. 4. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1. 5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator. 6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. 7. Current medical diagnosis of type 1 or type 2 diabetes mellitus. 8. HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1. 9. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable). 10. Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1. 11. Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document. 12. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk. 13. Excessive alcohol consumption (\> 2 Drinks, 60 ml of Whisky Per Day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | 0, and 28 days | Blood Glucose Concentration mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Insulin | 0, and 28 days | Blood Insulin Concentration mcIU/mL |
| Continuous Glucose Monitoring | 0, and 28 days | Continuous Blood Glucose Monitoring mg/dL |
| Total Cholesterol | 0, and 28 days | Total blood cholesterol mg/dL |
| Low-density lipoprotein (LDL) cholesterol | 0, and 28 days | Blood Low-density lipoprotein (LDL) cholesterol mg/dL |
| High-density lipoprotein (HDL) cholesterol | 0, and 28 days | Blood High-density lipoprotein (HDL) cholesterol mg/dL |
| HbA1c | 0, and 28 days | Percent (%) blood HbA1c level |
| Weight | 0, and 28 days | kg of Body Weight |
| Height | 0, and 28 days | Height in meters (m) |
| Body Mass Index (BMI) | 0, and 28 days | Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters. |
| Waist Circumference | 0, and 28 days | Waist Circumference in cm |
| Triglycerides | 0, and 28 days | Blood Triglycerides mg/dL |
Countries
India
Contacts
Primary ContactAnoop Misra, PhD
Outcome results
None listed