A study to compare soy and milk protein effects on glucose regulation and appetite among healthy Indians

Completed

• Conditions: Healthy volunteers between 20 and 35 years of age,Normal BMI,without history of soy or whey protein allergy

• Registration Number: CTRI/2018/03/012426
• Lead Sponsor: Dr Neeraj Pandey

Brief Summary

High quality protein intake has been linked to positive outcomes (growth and development, muscle mass improvement etc.,) from children to elderly population. Increased probability of greater fat loss with improvement in lean mass is some of the supporting findings with high protein intake. Data from diabetic population has also supported the role of greater protein intake on glucose homeostasis. However, currently there is lack of understanding, particularly in terms of the type and the level of protein intake on glucose homeostasis in Indian population. This is of relevance particularly in an Indian scenario, where susceptibility to develop chronic diseases like diabetes is high. In addition, majority of the Indians practice vegetarianism and even when they consume non-vegetarian based diet quantity and quality of meal protein is disputed. Current study  is an attempt to explore the effects of 2 types of protein (whey protein (WP) and isolated soy protein (ISP)) and 2 levels of protein (15 and 30% Energy) on glucose homeostasis and satiety in Indian healthy subjects. Any positive outcomes from this pilot study will have wider implication in a clinical setting for instance type 2 diabetes where effects might be far better and of greater relevance. Further, this could also help derive at a standard practice of protein supplementation not only in healthy but also in various clinical states.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-06
• Study Completion: 2015-09-21
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

BMI range 18.5 to 25 Kg/m2.

Exclusion Criteria

• 1.history of diabetes,hypertension, any chronic illness, 2.
• history of soy or whey protein allergy 3.
• acute illness within the last 2 weeks 4.
• involved in competitive sports 5.
• Weight loss or again in the past six months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic and insulinemic response following WP (15% Vs 30%) and ISP (15% Vs 30%).	Blood samples for glycemic and insulinemic response: -10, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300 mins | Satiety test: Basal,10,40,70,100,130,160,190,220,250,300 mins
Satiety scores	Blood samples for glycemic and insulinemic response: -10, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300 mins | Satiety test: Basal,10,40,70,100,130,160,190,220,250,300 mins

Secondary Outcome Measures

Name	Time	Method
Indirect calorimetry (VO2, VCO2, RQ and EE)

Trial Locations

Locations (1)

St.Johns Medical College; 🇮🇳 Bangalore, KARNATAKA, India

St.Johns Medical College

🇮🇳Bangalore, KARNATAKA, India

Dr Sucharita S

Principal investigator

08049466322

sucharita@stjohns.in