MedPath

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

Not yet recruiting
Conditions
Healthy Human Volunteers
Registration Number
CTRI/2025/05/087621
Lead Sponsor
Amway Global Services India Pvt Ltd
Brief Summary

The glycemic index (GI) is a measure of the blood glucose-raising potential of the Carbohydrate content of a food compared to a reference food

(generally pure glucose) (https://lpi.oregonstate.edu/mic/food-beverages/glycemic-index-glycemic-load). It is measured in a scale of 0-100 where below 55 is considered as low glycemic index, 56- 69 as medium glycemic index and 70 and above as high glycemic index. Foods that have refined sugar contents have generally more glycemic index and might affect the

blood sugar levels whereas foods with typically less sugar and more fibre have less glycemic index. Subjects who fulfil the eligibility criteria will be enrolled in the study after

signing the informed consent form. Present study is aimed to evaluate the glycemic index of Seven food products

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Male
Target Recruitment
16
Inclusion Criteria
  • 1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years male subjects 2.Fasting blood glucose levels less than 100mg per dL.
  • 3.HOMA IR (Homeostasis Model Assessment of Insulin Resistance) less than 2.5 as per American Diabetes Association (ADA) 4.Glycosylated Hemoglobin (HbA1c) less than 5.6 as per American Diabetes Association (ADA 5.BMI should be between 18.5 to 25 kg per m2 6.Lipid profile (Total cholesterol) within normal range as applicable 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
  • 1.Total cholesterol higher than normal range.
  • 2.Subjects particularly on any special diet 3.Subjects suffering from any systemic disorders (diabetes mellitus, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV) 4.current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 5.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
NameTimeMethod
To assess glycemic index using blood sugarTo assess glycemic index using blood sugar | levels measured at fixed intervals at 7 time points (-5, 15, 30, 45, 60, 90 and 120 min)
levels measured at fixed intervals.To assess glycemic index using blood sugar | levels measured at fixed intervals at 7 time points (-5, 15, 30, 45, 60, 90 and 120 min)
Secondary Outcome Measures
NameTimeMethod
- To assess change in hematological andbiochemical parameters from baseline to end of

Trial Locations

Locations (1)

NRR Hospital

🇮🇳

Bangalore, KARNATAKA, India

NRR Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Madhusudan C
Principal investigator
drmadhusudanmadhu123@gmail.com

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