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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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06454773
Enrollment
130
Registered
2024-06-12
Start date
2024-06-01
Completion date
2024-12-31
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervention

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.

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

Interventions

DIETARY_SUPPLEMENTNCT/NFT

extract from black pepper and hemp hull

Sponsors

Brightseed
CollaboratorINDUSTRY
Diabetes Foundation, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Bioactive extract vs placebo

Intervention model description

double-blind placebo controlled

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
fasting blood glucose30 days

Secondary

MeasureTime frame
Body weight30 days

Countries

India

Contacts

Primary ContactAnoop Misra
anoopmisra@gmail.com49101222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026