Evaluating the effects of hemp and black pepper compounds on blood sugar levels in pre-diabetic individuals

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

This study is testing whether compounds from hemp and black pepper can help lower blood sugar levels in people who are pre-diabetic.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 25 Years to 60 Years
• Sex: All
• Sponsor: Diabetes Foundation, India (Academic / other)
• Locations: 1 site (Delhi)
• Trial ID: NCT06454773 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the impact of bioactive compounds extracted from hemp hull and black pepper on fasting blood glucose levels in pre-diabetic individuals. Participants will undergo a one-week run-in period while maintaining their usual diet and exercise routines before being randomized into either an intervention or control group. Key measurements will include blood glucose levels, insulin, HbA1c, and various anthropometric data. The study will utilize a randomized, placebo-controlled parallel arm design to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates for this study are pre-diabetic individuals with a BMI of 25-30 kg/m2 and specific waist circumference measurements.

Not a fit: Patients who have experienced significant weight changes or have a history of gastrointestinal surgery or eating disorders may not benefit from this study.

Why it matters

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

How similar studies have performed: While the specific combination of hemp and black pepper is novel, similar studies on dietary interventions for blood glucose management have shown promising results.

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).

Where this trial is running

Delhi

• National Diabetes, obesity and cholesterol foundation (NDOC) — Delhi, India (Recruiting)

Study contacts

• Study coordinator: Anoop Misra

Conditions Intervention