Clinical study toevaluate the effect of flavoured oats and blended oil with antioxidants in preâ??diabetes subjects
Phase 4
- Conditions
- Health Condition 1: null- Pre-Diabetics
- Registration Number
- CTRI/2015/12/006429
- Lead Sponsor
- Spectrum Clinical Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
• Subjects of either sex in the age group between 30 to 45 years
• Pre-diabetics
• Willingness to maintain current activity levels and follow the prescribed diet.
• Preferably non-smokers, non-alcoholic and non- tobacco users
Exclusion Criteria
• Recent history (past 12 months) of drug abuse or alcohol abuse
• Current smoker
• Women who are pregnant, lactating, or planning to become pregnant.
• Liver disorders.
• Congestive cardiac failure, acute myocardial infarction within last 1 month
• Subjects who are unlikely to comply with Protocol requirements e.g. uncooperative attitude, subjects who are frequent travelers, inability to return for follow up visits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of flavoured oats in pre diabetic subjects as an integral part of breakfast using Ambulatory glucose profile (AGP) & glycemic variabilityTimepoint: 14 Days from Baseline Visit
- Secondary Outcome Measures
Name Time Method To evaluate the effect of oats on satiety using satiety index. <br/ ><br>Hunger using food frequency questionnaire and fullness questionnaire. <br/ ><br>To measure body fat composition and body mass index. <br/ ><br>Effect of flavoured oats and blended oils with antioxidants on FBG and PP and Lipid profile. <br/ ><br>To evaluate 2nd Meal EffectTimepoint: 14 and 105 Days from Baseline Visit