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A study to evaluate effect of consumption of food products on Blood Sugar in healthy human volunteers

A study to evaluate effect of consumption of food products on Glycemic index in healthy human volunteers - GI -Glycemic Index

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048985
Enrollment
14
Registered
2023-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

None listed

Interventions

Intervention1: Product 1 – BDK-01: BDK-01 - 46.875 g in 200 ml water will be given orally to the subjects on Day 4/Visit-3,once during the Study Intervention2: Product 2 - BDK-01: BDK-01 - 21 g + 300

Sponsors

Amway Global Services India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years – male and female (1:1 ratio) 2.Fasting blood glucose levels 3.BMI should be between 18.5 to 25 kg/m2 4.Lipid profile (Total cholesterol) within normal range as applicable 5.Agree to participate in the study 6.Able and willing to follow all study related instructions. 7.Must be willing to give written informed consent and comply with the study procedures. 8.Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.

Exclusion criteria

Exclusion criteria: 1.Subjects with BMI less than 18.5kg/m2 or more than 25kg/m2 will be excluded from the study. 2.Total cholesterol higher than normal range. 3.Subjects particularly on any special diet 4.Subjects suffering from any systemic disorders (diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV) 5.current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 6.Pregnant or lactating women 7.Patient having participated in any other clinical trial within one month prior to screening

Design outcomes

Primary

MeasureTime frame
To assess glycemic index using blood sugar levels measured at fixed intervalsTimepoint: The Glycaemic Index of the test products on Day 4, Day 7, Day 13 and Day 16 will be compared with reference product on day 1 and day 10 at Fixed intervals of -5, 15, 30, 45, 60, 90 and 120 min.—

Secondary

MeasureTime frame
- To assess change in hematological and biochemical parameters from baseline to end of the study. - Assessment adverse events during the study period. Timepoint: at baseline and end of the Study—

Countries

India

Contacts

Public ContactSudha Raj

Amway Global Services India Pvt Ltd

Palaniyamma.Durairaj@Amway.com7022247227

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026