Actively Recruiting
Impact of Bioactive Compounds From Hemp Hull and Black Pepper on Fasting Blood Glucose in People With Pre-diabetes: A Randomized Placebo-Controlled Trial
Led by Diabetes Foundation, India · Updated on 2024-06-12
130
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
D
Diabetes Foundation, India
Lead Sponsor
B
Brightseed
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of bioactive compounds extracted from hemp hull and black pepper on fasting blood glucose levels in people with pre-diabetes. This randomized, double-blind, placebo-controlled trial involves free-living Asian Indian adults aged 25 to 60 years who meet specific criteria related to BMI, waist circumference, and fasting blood glucose. The study aims to understand how this dietary supplement impacts various measures of blood sugar control and body measurements over a 30-day period. Participants will first complete a one-week run-in period during which they maintain their usual diet and exercise routines. After this, those who meet the study's inclusion and exclusion criteria will be randomly assigned to receive either the bioactive compound supplement or a placebo. The intervention involves daily consumption of the extract from black pepper and hemp hull, while the control group receives a placebo. The study will monitor changes in fasting blood glucose and body weight as primary and secondary outcomes. Throughout the study, participants will undergo various assessments including 24-hour diet recalls, food frequency questionnaires, measurements of height, weight, waist circumference, and blood tests for fasting glucose, insulin, HbA1c, and lipid profiles. Continuous glucose monitoring is also used to evaluate post-meal glucose regulation. Researchers will track adherence and safety, with the total study duration around one month. This comprehensive monitoring helps understand the supplement's impact on blood sugar and related metabolic measures.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prediabetic individuals with BMI between 25 and 30 kg/m2
- Waist circumference at least 80 cm for women and 90 cm for men
- Fasting blood glucose between 100 and 125 mg/dL
- Age between 25 and 60 years
- Able to maintain usual diet and exercise during run-in period
You will not qualify if you...
- Weight loss or gain of 4.5 kg or more within 90 days before the first visit
- Use of weight loss medications within 90 days before the first visit
- History of gastrointestinal surgery or cosmetic fat reduction procedures
- Use of dietary supplements affecting weight or appetite within 30 days before the first visit
- History of extreme diets or eating disorders diagnosed by a health professional
- Current diagnosis of type 1 or type 2 diabetes
- HbA1c 6.5% or higher at first visit
- Chronic gastrointestinal disorders except mild lactose intolerance or reflux
- Signs or symptoms of active infection within 5 days before first visit
- Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception
- Any condition interfering with consent, protocol compliance, result interpretation, or safety
- Excessive alcohol consumption over 2 drinks (60 ml whisky) per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants take bioactive compound supplements extracted from hemp hull and black pepper or placebo to study their impact on fasting blood glucose and other health measures.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
National Diabetes, obesity and cholesterol foundation (NDOC)
Delhi, India, 110016
Actively Recruiting
Research Team
A
Anoop Misra
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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