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

February 1, 2016 updated by: Unilever R&D
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Randalls Road, Surrey
      • Leatherhead, Randalls Road, Surrey, United Kingdom, KT22 7RY
        • Leatherhead Food Research UK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive incremental area under the curve (iAUC)
Time Frame: 120 minutes
120 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Positive incremental area under the curve (iAUC)
Time Frame: 180 minutes
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Investigators

  • Principal Investigator: Sarah Hull, Leatherhead Food Research UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10020V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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