Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

NCT ID: NCT01456754

Last Updated: 2011-12-15

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.

Detailed Description

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Conditions

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Glucose Intolerance

Keywords

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Insulin Metabolism Glucose Metabolism Substrate Partitioning Muscle Biopsies Feeding Frequency Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High feeding frequency (14x)

Group Type EXPERIMENTAL

High feeding frequency (14x)

Intervention Type DIETARY_SUPPLEMENT

14 meals a day

low feeding frequency (3x)

Group Type EXPERIMENTAL

low feeding frequency (3x)

Intervention Type DIETARY_SUPPLEMENT

3 meals a day

Interventions

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low feeding frequency (3x)

3 meals a day

Intervention Type DIETARY_SUPPLEMENT

High feeding frequency (14x)

14 meals a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI: 20-35 kg/m2
* Gender: Male
* Age: subjects has to be older than 18 and younger than 70 years old
* Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l.
* Caucasian

Exclusion Criteria

1. Lactose intolerant
2. Diabetes Mellitus
3. Cardiovascular diseases
4. Stomach and intestinal diseases
5. Normal glucose levels after 2 hours
6. Anticoagulants
7. Medication that has a effect on energy and glucose homeostasis and absorption of foods
8. Conditions or situations when subjects can't lose 500 ml blood
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Nederlandse Zuivel Organisatie

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wim Saris, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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University of Maastricht

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC 10-3-057

Identifier Type: -

Identifier Source: org_study_id