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

Last updated: July 23, 2024
Sponsor: Brightseed
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Placebo Control

N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

Clinical Study ID

NCT06417840
1.4/FCDOC/EC/HAO/2024-25
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 theInvestigator, are likely to markedly affect weight loss or appetite within 30 daysof visit 1.

  5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by theInvestigator.

  6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or bingeeating) 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 ormalabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseasesare acceptable).

  10. Signs or symptoms of an active infection of clinical relevance within 5 days ofvisit 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 ofchildbearing potential and is unwilling to commit to the use of a medically approvedform of contraception throughout the study period. The method of contraception mustbe recorded in the source document.

  12. Any condition the Investigator believes would interfere with his or her ability toprovide informed consent, comply with the study protocol, or which might confoundthe 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

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Placebo Control
Phase:
Study Start date:
June 22, 2024
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Diabetes Foundation (India)

    New Delhi, 110 016
    India

    Active - Recruiting

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