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

December 14, 2011 updated by: Maastricht University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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
      • Maastricht, Netherlands
        • University of Maastricht

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High feeding frequency (14x)
Dietary supplement: High feeding frequency (14x)
14 meals a day
EXPERIMENTAL: low feeding frequency (3x)
Dietary supplement: low feeding frequency (3x)
3 meals a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose metabolism
Time Frame: 24 hour profile
24 hour profile
Insulin metabolism
Time Frame: 24 hour profile
24 hour profile

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
Time Frame: 24 hour profiles
24 hour profiles
Metabolic markers (FFA and TG metabolism)
Time Frame: 24 hour profile
24 hour profile

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Nederlandse Zuivel Organisatie

Investigators

  • Principal Investigator: Wim Saris, Prof. MD, Maastricht University

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

December 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (ESTIMATE)

October 21, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2011

Last Update Submitted That Met QC Criteria

December 14, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 10-3-057

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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