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

NCT06454773 | Recruiting Phase 3 DMC

• 1 other identifier: F.No 1.4 FCDOC/EC/HAO/2024-25
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This is randomized controlled parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. 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.

Conditions

Intervention

Outcome Measures

Primary Outcomes (1)

• fasting blood glucose

  30 days

Secondary Outcomes (1)

• Body weight

  30 days

Study Arms (2)

intervention

ACTIVE COMPARATOR

bioactive compound from black pepper and hemp hull

Dietary Supplement: NCT/NFT

control

PLACEBO COMPARATOR

Placebo

Dietary Supplement: NCT/NFT

Interventions

NCT/NFT DIETARY_SUPPLEMENT

extract from black pepper and hemp hull

control; intervention

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Weight loss or gain ≥4.5 kg within 90 days of visit 1.
• Use of weight loss medications within 90 days of visit 1
• History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
• 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.
• History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
• Current medical diagnosis of type 1 or type 2 diabetes mellitus.
• HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
• History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
• 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.
• 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.
• 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.
• Excessive alcohol consumption (\> 2 Drinks, 60 ml of Whisky Per Day).

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• Brightseed: collaborator

Study Sites (1)

National Diabetes, obesity and cholesterol foundation (NDOC)

Delhi, 110016, India

RECRUITING

Central Study Contacts

Anoop Misra

CONTACT

49101222; anoopmisra@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Bioactive extract vs placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, President

Model Details: double-blind placebo controlled

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

IN (1)