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

Not Applicable

Registration Number: CTRI/2023/08/056568

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

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)

-Fasting blood glucose levels less than 100mg/dL.

-BMI should be between 18.5 to 23 kg/m2

-Lipid profile (Total cholesterol) within normal range as applicable

-Agree to participate in the study

-Able and willing to follow all study related instructions.

-Must be willing to give written informed consent and comply with the study procedures.

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

Exclusion Criteria

-Subjects with BMI less than 18.5kg/m2 or more than 23 kg/m2 will be excluded from the study.

-Total cholesterol higher than normal range.

-Subjects particularly on any special diet

-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)

-current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders

-Pregnant or lactating women

-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 <br/ ><br>levels measured at fixed intervalsTimepoint: The Glycaemic Index of the test products on Day-4 Day-7 Day-10 Day-16 Day-19 & Day-22 will be compared with reference product on Day-1 & Day-13 at <br/ ><br>Fixed intervals of -5 15 30 45 60 90 & 120 <br/ ><br>min

Secondary Outcome Measures

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