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

Unilever logo

Unilever

Status

Completed

Conditions

Healthy

Treatments

Other: barley
Other: Control (market standard)
Other: chickpea flour
Other: guar gum
Other: wheat flour

Study type

Interventional

Funder types

Industry

Identifiers

NCT02814357
FDS-NAA-0224

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

50 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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