To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: wheat flour; Other: Control (market standard); Other: chickpea flour; Other: guar gum; Other: barley

• Registration Number: NCT02814357
• Lead Sponsor: Unilever R&D

Brief Summary

Double-blind, randomized, controlled, cross-over design with 3 test products and one control product.

To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-27
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy male and female subjects between > 20 and < 50 years of age
• BMI of >18 and < 23 kg/m2
• Fasting blood glucose value of volunteer is > 3.4 and <6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening

Exclusion Criteria

• Chronic smokers, tobacco chewers and drinkers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fibre 2	guar gum	80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley
High fibre 3	wheat flour	77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley
High fibre 3	guar gum	77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley
Control (market standard)	Control (market standard)	100 g wheat flour (atta)
High fibre 1	chickpea flour	81% wheat flour (atta) + 15% chickpea + 4% guar gum
High fibre 2	barley	80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley
High fibre 3	barley	77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley
High fibre 1	wheat flour	81% wheat flour (atta) + 15% chickpea + 4% guar gum
High fibre 2	wheat flour	80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley
High fibre 2	chickpea flour	80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley
High fibre 1	guar gum	81% wheat flour (atta) + 15% chickpea + 4% guar gum
High fibre 3	chickpea flour	77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley

Primary Outcome Measures

Name	Time	Method
Positive incremental area under blood glucose curve	0-120 minutes

Secondary Outcome Measures

Name	Time	Method
Total area under the serum insulin curve	0-120 minutes

Trial Locations

Locations (1)

Lambda Therapeutics Research Ltd (LTRL); 🇮🇳 Ahmedabad, Near Gujrat High Court, SG Highway, Gota, India