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

June 18, 2013 updated by: Unilever R&D

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Hanzeplein 1
      • Groningen, Hanzeplein 1, Netherlands, 9713 GZ
        • QPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

  • healthy males
  • Age at start of the study ≥18 and ≤ 50 years
  • Not smoking
  • Body mass index (BMI) ≥ 20 and ≤ 28 kg/m2
  • Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbohydrate based food mix 1
Slowly digestible carbohydrate
Dietary supplement: Carbohydrate based food mix 2
Carbohydrate based food
Other Names:
  • Slowly digestible carbohydrate
Dietary supplement: Control carbohydrate based food
Carbohydrate based food
Other Names:
  • Rapidly digestible carbohydrate
Experimental: Carbohydrate based food mix 2
Slowly digestible carbohydrate
Dietary supplement: Control carbohydrate based food
Carbohydrate based food
Other Names:
  • Rapidly digestible carbohydrate
Dietary supplement: Carbohydrate based food mix 1
Carbohydrate based food
Other Names:
  • Slowly digestible carbohydrate
Active Comparator: Control carbohydrate based food
Rapidly digestible carbohydrate
Dietary supplement: Carbohydrate based food mix 2
Carbohydrate based food
Other Names:
  • Slowly digestible carbohydrate
Dietary supplement: Carbohydrate based food mix 1
Carbohydrate based food
Other Names:
  • Slowly digestible carbohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.
Time Frame: Measured during 360 min for 3 periods
Measured during 360 min for 3 periods

Secondary Outcome Measures

Outcome Measure
Time Frame
Total blood glucose and insulin
Time Frame: Measured during 360 min for 3 periods
Measured during 360 min for 3 periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Investigators

  • Principal Investigator: Khalid Abd-Elaziz, QPS Netherlands BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDS-NAA-0758

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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