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

NCT ID: NCT01734590

Last Updated: 2013-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Carbohydrate based food mix 1

Slowly digestible carbohydrate

Group Type EXPERIMENTAL

Carbohydrate based food mix 2

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food

Control carbohydrate based food

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food

Carbohydrate based food mix 2

Slowly digestible carbohydrate

Group Type EXPERIMENTAL

Carbohydrate based food mix 1

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food

Control carbohydrate based food

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food

Control carbohydrate based food

Rapidly digestible carbohydrate

Group Type ACTIVE_COMPARATOR

Carbohydrate based food mix 1

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food

Carbohydrate based food mix 2

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food

Interventions

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Carbohydrate based food mix 1

Carbohydrate based food

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate based food mix 2

Carbohydrate based food

Intervention Type DIETARY_SUPPLEMENT

Control carbohydrate based food

Carbohydrate based food

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Slowly digestible carbohydrate Slowly digestible carbohydrate Rapidly digestible carbohydrate

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khalid Abd-Elaziz

Role: PRINCIPAL_INVESTIGATOR

QPS Netherlands BV

Locations

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QPS

Groningen, Hanzeplein 1, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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FDS-NAA-0758

Identifier Type: -

Identifier Source: org_study_id

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