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

Launched by BRIGHTSEED · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how a specific bioactive compound can affect fasting blood sugar levels in Asian Indians who have pre-diabetes, a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. The study is looking for participants aged between 18 to 65 years who have a fasting blood glucose level between 100-125 mg/dL and a body mass index (BMI) of 25-30. Participants will be randomly assigned to either receive the bioactive compound or a placebo (a dummy treatment) after a one-week period where they maintain their usual diet and exercise.

If you join the study, you’ll be asked to complete some questionnaires about your eating habits and undergo measurements like height, weight, and waist circumference. Blood tests will also be done to check your fasting blood glucose and other important markers. This trial is currently recruiting participants, and it's important to note that there are specific criteria for eligibility, including no recent weight changes or use of weight loss medications, and no history of diabetes or certain medical conditions. If you’re interested and meet the criteria, this study could provide valuable insights into managing blood sugar levels with dietary changes.

Gender

ALL

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).