To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes

Not Applicable

Recruiting

• Conditions: PreDiabetes
• Interventions: Dietary Supplement: Placebo Control; Dietary Supplement: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

• Registration Number: NCT06417840
• Lead Sponsor: Brightseed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-16
• Study Start: 2024-06-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Placebo Control	-
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)	N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)	-

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose	0, and 28 days	Blood Glucose Concentration mg/dL

Secondary Outcome Measures

Name	Time	Method
HbA1c	0, and 28 days	Percent (%) blood HbA1c level
Continuous Glucose Monitoring	0, and 28 days	Continuous Blood Glucose Monitoring mg/dL
Fasting Blood Insulin	0, and 28 days	Blood Insulin Concentration mcIU/mL
Height	0, and 28 days	Height in meters (m)
Waist Circumference	0, and 28 days	Waist Circumference in cm
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
Triglycerides	0, and 28 days	Blood Triglycerides mg/dL
Weight	0, and 28 days	kg of Body Weight
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.

Trial Locations

Locations (1)

Diabetes Foundation (India); 🇮🇳 New Delhi, India