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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02814357
Enrollment
50
Registered
2016-06-27
Start date
2011-07-31
Completion date
2011-07-31
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Blood glucose, serum insulin

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.

Interventions

OTHERControl (market standard)
OTHERchickpea flour
OTHERbarley

Sponsors

Unilever R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Positive incremental area under blood glucose curve0-120 minutes

Secondary

MeasureTime frame
Total area under the serum insulin curve0-120 minutes

Other

MeasureTime frame
Slope to Cmax0-120 minutes
Glucose concentration180 minutes
Cmax glucose0-120 minutes
Total area under the glucose curve0-180 minutes
Total area under the curve of appetite and mood0-120 minutes
Insulin concentration180 minutes
Tmax glucose0-120 minutes

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026