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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Active 7; Other: Active 8; Other: Active 1; Other: Active 2; Other: Active 3; Other: Active 4; Other: Active 5; Other: Active 6; Other: Control; Other: Active 9; Other: Active 10; Other: Active 11

• Registration Number: NCT02671214
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-11
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2016-01
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-01
• Last Update Submitted: 2016-02-01
• Study First Posted: 2016-02-02
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Positive incremental area under the curve (iAUC)	120 minutes

Secondary Outcome Measures

Name	Time	Method
Positive incremental area under the curve (iAUC)	180 minutes

Trial Locations

Locations (1)

Leatherhead Food Research UK; 🇬🇧 Leatherhead, Randalls Road, Surrey, United Kingdom