To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes: A Randomized Placebo-Controlled Parallel Arm Trial

Launched by DIABETES FOUNDATION, INDIA · Jun 6, 2024

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ClinConnect Summary

This clinical trial is studying the effects of natural compounds from hemp hull and black pepper on blood sugar levels in people who are at risk of developing diabetes, known as pre-diabetes. Participants will follow their normal diet and exercise for a week before being randomly assigned to either the treatment group, which will receive the bioactive compounds, or a control group that will receive a placebo (a non-active substance). The trial aims to understand if these compounds can help lower fasting blood glucose levels, which is important for preventing diabetes.

To be eligible for the trial, participants should be adults with a body mass index (BMI) between 25 and 30, and specific waist measurements, indicating they are overweight. They must also have fasting blood glucose levels between 100-125 mg/dL. However, individuals with certain health conditions, recent significant weight changes, or those taking specific medications or supplements will not be eligible. Throughout the trial, participants will have their diet, weight, and blood sugar levels monitored to assess the effects of the treatment. This study is currently recruiting participants, and it is a great opportunity for those who meet the criteria to contribute to important research on diabetes prevention.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
• Exclusion Criteria:
• • Prediabetic individuals of BMI range 25-30 kg/m2 and waist circumference ≥80cm for women and ≥90cm for men with Fasting Blood Glucose between 100-125 mg/dL.
• • 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).