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Completed

NCT Number: NCT02671214

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

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leatherhead Food Research UK

Leatherhead, Randalls Road, Surrey, KT22 7RY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Control

Other

100 g high fibre flour

Active 2

Other

98 g high fibre flour + 2 g guar gum

Active 3

Other

88 g high fibre flour + 2 g guar gum + 10 g legume flour

Active 4

Other

83 g high fibre flour + 2 g guar gum + 15 g legume flour

Active 5

Other

96 g high fibre flour + 4 g guar gum

Active 6

Other

86 g high fibre flour + 4 g guar gum + 10 g legume flour

Active 7

Other

81 g high fibre flour + 4 g guar gum + 15 g legume flour

Active 8

Other

94 g high fibre flour + 6 g guar gum

Active 9

Other

98 g high fibre flour + 2 g konjac mannan

Active 10

Other

96 g high fibre flour + 4 g konjac mannan

Active 11

Other

100 g low fibre flour

Active 1

Other

85 g high fibre flour + 15 g legume flour

Primary outcomes

  1. Positive incremental area under the curve (iAUC)

    Time frame: 120 minutes

Secondary outcomes

  1. Positive incremental area under the curve (iAUC)

    Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2016
Registry last updated
Feb 2, 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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