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

Not Applicable

Registration Number: CTRI/2023/01/048985

Lead Sponsor: Amway Global Services India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years â?? male and female (1:1 ratio)

2.Fasting blood glucose levels < 100mg/dL.

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.Subjectâ??s complete blood count parameters to be within clinically acceptable range by Investigator.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
-To assess change in hematological and biochemical parameters from baseline to end of the study. <br/ ><br>-Assessment adverse events during the study period. <br/ ><br>Timepoint: at baseline and end of the Study