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 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.

Study Overview

• Status: Recruiting
• Conditions: Intervention
• Intervention / Treatment: Dietary supplement: NCT/NFT

Detailed Description

To study the impact of bioactive compound supplementation on fasting blood glucose.

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

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anoop Misra; Phone Number: 49101222; Email: anoopmisra@gmail.com

Study Locations

• India
  • Delhi, India, 110016
    • Recruiting
    • National Diabetes, obesity and cholesterol foundation (NDOC)
    • Contact: Seema Gulati; Phone Number: 09312069151; Email: seemagulati2007@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention; bioactive compound from black pepper and hemp hull	Dietary supplement: NCT/NFT; extract from black pepper and hemp hull
Placebo Comparator: control; Placebo	Dietary supplement: NCT/NFT; extract from black pepper and hemp hull

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fasting blood glucose	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Body weight	30 days

Collaborators and Investigators

• Sponsor: Diabetes Foundation, India
• Collaborators: Brightseed

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: F.No 1.4 FCDOC/EC/HAO/2024-25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No