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

To Evaluate the Effect of 4 Different Flour Compositions of Selected Fibres and Flours, on Post-prandial Plasma Glucose (PPG) and Serum Insulin Levels in Normal Indian Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Control (market standard); Other: wheat flour; Other: chickpea flour; Other: guar gum; Other: barley

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Near Gujrat High Court, SG Highway, Gota
    • Ahmedabad, Near Gujrat High Court, SG Highway, Gota, India, 380 061 Gujrat
      • Lambda Therapeutics Research Ltd (LTRL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control (market standard); 100 g wheat flour (atta)	Other: Control (market standard)
Active Comparator: High fibre 1; 81% wheat flour (atta) + 15% chickpea + 4% guar gum	Other: wheat flour; Other: chickpea flour; Other: guar gum
Active Comparator: High fibre 2; 80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley	Other: wheat flour; Other: chickpea flour; Other: guar gum; Other: barley
Active Comparator: High fibre 3; 77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley	Other: wheat flour; Other: chickpea flour; Other: guar gum; Other: barley

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive incremental area under blood glucose curve	0-120 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Total area under the serum insulin curve	0-120 minutes

Other Outcome Measures

Outcome Measure	Time Frame
Cmax glucose	0-120 minutes
Tmax glucose	0-120 minutes
Slope to Cmax	0-120 minutes
Glucose concentration	180 minutes
Insulin concentration	180 minutes
Total area under the glucose curve	0-180 minutes
Total area under the curve of appetite and mood	0-120 minutes

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Rakesh Patel, Dr., Lambda Therapeutic Research Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Blood glucose, serum insulin
• Other Study ID Numbers: FDS-NAA-0224