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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive incremental area under the curve (iAUC) |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive incremental area under the curve (iAUC) |  | 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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guar gum, konjac mannan, blood glucose, legume flour