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Completed

NCT Number: NCT02814357

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

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.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lambda Therapeutics Research Ltd (LTRL)

Ahmedabad, Near Gujrat High Court, SG Highway, Gota, 380 061 Gujrat, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control (market standard)

Other

wheat flour

Other

chickpea flour

Other

guar gum

Other

barley

Other

Primary outcomes

  1. Positive incremental area under blood glucose curve

    Time frame: 0-120 minutes

Secondary outcomes

  1. Total area under the serum insulin curve

    Time frame: 0-120 minutes

Other outcomes

  1. Cmax glucose

    Time frame: 0-120 minutes

  2. Tmax glucose

    Time frame: 0-120 minutes

  3. Slope to Cmax

    Time frame: 0-120 minutes

  4. Glucose concentration

    Time frame: 180 minutes

  5. Insulin concentration

    Time frame: 180 minutes

  6. Total area under the glucose curve

    Time frame: 0-180 minutes

  7. Total area under the curve of appetite and mood

    Time frame: 0-120 minutes

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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