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The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses

Unilever logo

Unilever

Status

Completed

Conditions

Healthy

Treatments

Other: Active 11
Other: Control
Other: Active 3
Other: Active 4
Other: Active 7
Other: Active 6
Other: Active 9
Other: Active 2
Other: Active 5
Other: Active 8
Other: Active 1
Other: Active 10

Study type

Interventional

Funder types

Industry

Identifiers

NCT02671214
10020V

Details and patient eligibility

About

Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.

Full description

This study was a double-blind, randomised, balanced incomplete block design exploratory study of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial glucose (PPG) response in capillary blood (finger prick) over a two and three hours period, relative to the control product. Every subject received the control and 4 out of the 11 treatments on five separate test days.

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Enrollment

42 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m2.
  • Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
  • A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).

Exclusion criteria

  • Use of medication which interferes with study measurements (as judged by the study physician).
  • Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
  • Reported weight loss/gain (>10%) in the last six month before the study

Trial design

42 participants in 12 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
100 g high fibre flour
Treatment:
Other: Control
Active 1
Active Comparator group
Description:
85 g high fibre flour + 15 g legume flour
Treatment:
Other: Active 1
Active 2
Active Comparator group
Description:
98 g high fibre flour + 2 g guar gum
Treatment:
Other: Active 2
Active 3
Active Comparator group
Description:
88 g high fibre flour + 2 g guar gum + 10 g legume flour
Treatment:
Other: Active 3
Active 4
Active Comparator group
Description:
83 g high fibre flour + 2 g guar gum + 15 g legume flour
Treatment:
Other: Active 4
Active 5
Active Comparator group
Description:
96 g high fibre flour + 4 g guar gum
Treatment:
Other: Active 5
Active 6
Active Comparator group
Description:
86 g high fibre flour + 4 g guar gum + 10 g legume flour
Treatment:
Other: Active 6
Active 7
Active Comparator group
Description:
81 g high fibre flour + 4 g guar gum + 15 g legume flour
Treatment:
Other: Active 7
Active 8
Active Comparator group
Description:
94 g high fibre flour + 6 g guar gum
Treatment:
Other: Active 8
Active 9
Active Comparator group
Description:
98 g high fibre flour + 2 g konjac mannan
Treatment:
Other: Active 9
Active 10
Active Comparator group
Description:
96 g high fibre flour + 4 g konjac mannan
Treatment:
Other: Active 10
Active 11
Active Comparator group
Description:
100 g low fibre flour
Treatment:
Other: Active 11

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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