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

NCT ID: NCT02814357

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control (market standard)

100 g wheat flour (atta)

Group Type PLACEBO_COMPARATOR

Control (market standard)

Intervention Type OTHER

High fibre 1

81% wheat flour (atta) + 15% chickpea + 4% guar gum

Group Type ACTIVE_COMPARATOR

wheat flour

Intervention Type OTHER

chickpea flour

Intervention Type OTHER

guar gum

Intervention Type OTHER

High fibre 2

80% wheat flour (atta) + 15% chickpea + 2% guar gum + 3% barley

Group Type ACTIVE_COMPARATOR

wheat flour

Intervention Type OTHER

chickpea flour

Intervention Type OTHER

guar gum

Intervention Type OTHER

barley

Intervention Type OTHER

High fibre 3

77% wheat flour (atta) + 15% chickpea + 3% guar gum + 5% barley

Group Type ACTIVE_COMPARATOR

wheat flour

Intervention Type OTHER

chickpea flour

Intervention Type OTHER

guar gum

Intervention Type OTHER

barley

Intervention Type OTHER

Interventions

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Control (market standard)

Intervention Type OTHER

wheat flour

Intervention Type OTHER

chickpea flour

Intervention Type OTHER

guar gum

Intervention Type OTHER

barley

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rakesh Patel, Dr.

Role: PRINCIPAL_INVESTIGATOR

Lambda Therapeutic Research Ltd.

Locations

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Lambda Therapeutics Research Ltd (LTRL)

Ahmedabad, Near Gujrat High Court, SG Highway, Gota, India

Site Status

Countries

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India

Other Identifiers

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FDS-NAA-0224

Identifier Type: -

Identifier Source: org_study_id

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