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

NCT ID: NCT02671214

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

100 g high fibre flour

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

100 g high fibre flour

Active 1

85 g high fibre flour + 15 g legume flour

Group Type ACTIVE_COMPARATOR

Active 1

Intervention Type OTHER

85 g high fibre flour + 15 g legume flour

Active 2

98 g high fibre flour + 2 g guar gum

Group Type ACTIVE_COMPARATOR

Active 2

Intervention Type OTHER

98 g high fibre flour + 2 g guar gum

Active 3

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

Group Type ACTIVE_COMPARATOR

Active 3

Intervention Type OTHER

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

Active 4

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

Group Type ACTIVE_COMPARATOR

Active 4

Intervention Type OTHER

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

Active 5

96 g high fibre flour + 4 g guar gum

Group Type ACTIVE_COMPARATOR

Active 5

Intervention Type OTHER

96 g high fibre flour + 4 g guar gum

Active 6

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

Group Type ACTIVE_COMPARATOR

Active 6

Intervention Type OTHER

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

Active 7

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

Group Type ACTIVE_COMPARATOR

Active 7

Intervention Type OTHER

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

Active 8

94 g high fibre flour + 6 g guar gum

Group Type ACTIVE_COMPARATOR

Active 8

Intervention Type OTHER

94 g high fibre flour + 6 g guar gum

Active 9

98 g high fibre flour + 2 g konjac mannan

Group Type ACTIVE_COMPARATOR

Active 9

Intervention Type OTHER

98 g high fibre flour + 2 g konjac mannan

Active 10

96 g high fibre flour + 4 g konjac mannan

Group Type ACTIVE_COMPARATOR

Active 10

Intervention Type OTHER

96 g high fibre flour + 4 g konjac mannan

Active 11

100 g low fibre flour

Group Type ACTIVE_COMPARATOR

Active 11

Intervention Type OTHER

100 g low fibre flour

Interventions

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Control

100 g high fibre flour

Intervention Type OTHER

Active 2

98 g high fibre flour + 2 g guar gum

Intervention Type OTHER

Active 3

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

Intervention Type OTHER

Active 4

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

Intervention Type OTHER

Active 5

96 g high fibre flour + 4 g guar gum

Intervention Type OTHER

Active 6

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

Intervention Type OTHER

Active 7

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

Intervention Type OTHER

Active 8

94 g high fibre flour + 6 g guar gum

Intervention Type OTHER

Active 9

98 g high fibre flour + 2 g konjac mannan

Intervention Type OTHER

Active 10

96 g high fibre flour + 4 g konjac mannan

Intervention Type OTHER

Active 11

100 g low fibre flour

Intervention Type OTHER

Active 1

85 g high fibre flour + 15 g legume flour

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Hull

Role: PRINCIPAL_INVESTIGATOR

Leatherhead Food Research UK

Locations

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Leatherhead Food Research UK

Leatherhead, Randalls Road, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

References

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Boers HM, MacAulay K, Murray P, Seijen Ten Hoorn J, Hoogenraad AR, Peters HPF, Vente-Spreeuwenberg MAM, Mela DJ. Efficacy of different fibres and flour mixes in South-Asian flatbreads for reducing post-prandial glucose responses in healthy adults. Eur J Nutr. 2017 Sep;56(6):2049-2060. doi: 10.1007/s00394-016-1242-9. Epub 2016 Jun 21.

Reference Type DERIVED
PMID: 27324141 (View on PubMed)

Other Identifiers

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10020V

Identifier Type: -

Identifier Source: org_study_id

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