Clinical study to evaluate the effect of flavoured oats and blended oil with antioxidants in preâ??diabetes subjects

A Prospective, Open Label, Parallel Group, Randomized Controlled clinical study to evaluate the effect of flavoured oats and blended oil with antioxidants in preâ??diabetes subjects - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/12/006429

Enrollment

Registered

2015-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pre-Diabetics

Interventions

Intervention1: Flavoured Oats and Blended oil with antioxidants: Subjects will be provided Flavoured Oats for Breakfast, Dose: Equivalent to Breakfast, Frequency: One time a day, Duration: 14 days an

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the effect of oats on satiety using satiety index. Hunger using food frequency questionnaire and fullness questionnaire. To measure body fat composition and body mass index. Effect of flavoured oats and blended oils with antioxidants on FBG and PP and Lipid profile. To evaluate 2nd Meal EffectTimepoint: 14 and 105 Days from Baseline Visit	—

Countries

India

Contacts

Public ContactSanjay Vekariya

Spectrum Healthcare

avelho@spectrumhealthcare.co.in02222846357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026