Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Carbohydrate based food mix 2; Dietary Supplement: Carbohydrate based food mix 1; Dietary Supplement: Control carbohydrate based food

• Registration Number: NCT01734590
• Lead Sponsor: Unilever R&D

Brief Summary

Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.

The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to the control.

Detailed Description

Twelve volunteers will participate in the study; each person will be studied on three different occasions at least one week apart, consuming the three different test products in a randomized order. Test products are carbohydrate-based food made from different flour mixes differing in their expected rate of intestinal starch digestion. The products are labeled with 13C starch.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carbohydrate based food mix 1	Carbohydrate based food mix 2	Slowly digestible carbohydrate
Carbohydrate based food mix 1	Control carbohydrate based food	Slowly digestible carbohydrate
Carbohydrate based food mix 2	Carbohydrate based food mix 1	Slowly digestible carbohydrate
Carbohydrate based food mix 2	Control carbohydrate based food	Slowly digestible carbohydrate
Control carbohydrate based food	Carbohydrate based food mix 1	Rapidly digestible carbohydrate
Control carbohydrate based food	Carbohydrate based food mix 2	Rapidly digestible carbohydrate

Primary Outcome Measures

Name	Time	Method
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.	Measured during 360 min for 3 periods

Secondary Outcome Measures

Name	Time	Method
Total blood glucose and insulin	Measured during 360 min for 3 periods

Trial Locations

Locations (1)

QPS; 🇳🇱 Groningen, Hanzeplein 1, Netherlands