Evaluating a compound's effect on blood sugar levels in pre-diabetic Asian Indians

To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial

This study is testing if two natural compounds can help lower blood sugar levels in Asian Indians who are pre-diabetic.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Brightseed (Industry-sponsored)
• Locations: 1 site (New Delhi)
• Trial ID: NCT06417840 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled, double-blinded study aims to assess the impact of two bioactive compounds, N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT), on fasting blood glucose levels in Asian Indians diagnosed with pre-diabetes. Participants will undergo a one-week run-in period while maintaining their usual diet and exercise before being randomized into either the intervention or control group. Key measurements will include dietary intake, anthropometric data, and various blood parameters such as fasting blood glucose and HbA1c levels.

Who should consider this trial

Good fit: Ideal candidates are Asian Indian adults with fasting blood glucose levels between 100-125 mg/dL and a BMI of 25-30 kg/m2.

Not a fit: Patients with a current diagnosis of type 1 or type 2 diabetes mellitus will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary intervention to help manage blood glucose levels in pre-diabetic patients.

How similar studies have performed: While similar studies have explored dietary interventions for blood glucose management, the specific compounds being tested in this study are novel.

Eligibility criteria

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).

Where this trial is running

New Delhi

• Diabetes Foundation (India) — New Delhi, India (Recruiting)

Study contacts

• Study coordinator: Anoop Misra, PhD

Conditions PreDiabetes