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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671214
• Other study ID #: 10020V
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: February 1, 2016
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2016
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Control
100 g high fibre flour
• Active 2
98 g high fibre flour + 2 g guar gum
• Active 3
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
• Active 5
96 g high fibre flour + 4 g guar gum
• Active 6
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
• Active 8
94 g high fibre flour + 6 g guar gum
• Active 9
98 g high fibre flour + 2 g konjac mannan
• Active 10
96 g high fibre flour + 4 g konjac mannan
• Active 11
100 g low fibre flour
• Active 1
85 g high fibre flour + 15 g legume flour

Locations

Country	Name	City	State
United Kingdom	Leatherhead Food Research UK	Leatherhead	Randalls Road, Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive incremental area under the curve (iAUC)		120 minutes	No
Secondary	Positive incremental area under the curve (iAUC)		180 minutes	No