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

Intervention Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06454773
• Other study ID #: F.No 1.4 FCDOC/EC/HAO/2024-25
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Diabetes Foundation, India
• Contact: Anoop Misra
• Phone: 49101222
• Email: anoopmisra[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Intervention
• Prediabetic State

Intervention

Dietary Supplement:
• NCT/NFT
extract from black pepper and hemp hull

Locations

Country	Name	City	State
India	National Diabetes, obesity and cholesterol foundation (NDOC)	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Foundation, India	Brightseed

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting blood glucose		30 days
Secondary	Body weight		30 days