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
NCT ID: NCT06454773
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
130 participants
INTERVENTIONAL
2024-06-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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To study the impact of intervention with bioactive compound on following measures of glycaemia:
* 24 hr AUC total from CGM Post-prandial glucose regulation
* iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry
* Fasting Insulin
* HbA1c
* Lipid profile Anthropometry
* Weight
* BMI
* Waist Circumference
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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intervention
bioactive compound from black pepper and hemp hull
NCT/NFT
extract from black pepper and hemp hull
control
Placebo
NCT/NFT
extract from black pepper and hemp hull
Interventions
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NCT/NFT
extract from black pepper and hemp hull
Eligibility Criteria
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Inclusion Criteria
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).
25 Years
60 Years
ALL
Yes
Sponsors
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Brightseed
INDUSTRY
Diabetes Foundation, India
OTHER
Responsible Party
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Dr Anoop Misra
Professor, President
Locations
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National Diabetes, obesity and cholesterol foundation (NDOC)
Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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F.No 1.4 FCDOC/EC/HAO/2024-25
Identifier Type: -
Identifier Source: org_study_id
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