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

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ClinicalTrials.gov Identifier: NCT02671214
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Control Other: Active 2 Other: Active 3 Other: Active 4 Other: Active 5 Other: Active 6 Other: Active 7 Other: Active 8 Other: Active 9 Other: Active 10 Other: Active 11 Other: Active 1 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses
Study Start Date : November 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Positive incremental area under the curve (iAUC) [ Time Frame: 120 minutes ]

Secondary Outcome Measures :
  1. Positive incremental area under the curve (iAUC) [ Time Frame: 180 minutes ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671214


Locations
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United Kingdom
Leatherhead Food Research UK
Leatherhead, Randalls Road, Surrey, United Kingdom, KT22 7RY
Sponsors and Collaborators
Unilever R&D
Investigators
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Principal Investigator: Sarah Hull Leatherhead Food Research UK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT02671214     History of Changes
Other Study ID Numbers: 10020V
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Keywords provided by Unilever R&D:
guar gum
konjac mannan
blood glucose
legume flour
Additional relevant MeSH terms:
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(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents