Diabetes Foundation (India)
New Delhi, 110 016, India
Location status: Recruiting
NCT Number: NCT06417840
This is randomized placebo controlled, double-blinded, 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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
New Delhi, 110 016, India
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products.
Placebo Control
Time frame: 0, and 28 days
Blood Glucose Concentration mg/dL
Time frame: 0, and 28 days
Blood Insulin Concentration mcIU/mL
Time frame: 0, and 28 days
Percent (%) blood HbA1c level
Time frame: 0, and 28 days
Continuous Blood Glucose Monitoring mg/dL
Time frame: 0, and 28 days
Total blood cholesterol mg/dL
Time frame: 0, and 28 days
Blood Low-density lipoprotein (LDL) cholesterol mg/dL
Time frame: 0, and 28 days
Blood High-density lipoprotein (HDL) cholesterol mg/dL
Time frame: 0, and 28 days
Blood Triglycerides mg/dL
Time frame: 0, and 28 days
kg of Body Weight
Time frame: 0, and 28 days
Height in meters (m)
Time frame: 0, and 28 days
Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters.
Time frame: 0, and 28 days
Waist Circumference in cm
Contact information is provided by the study sponsor or research team.
Brightseed
Industry
To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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