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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01456754

First Posted: October 21, 2011

Last Update Posted: December 15, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Nederlandse Zuivel Organisatie

Information provided by (Responsible Party):

Maastricht University Medical Center

Purpose

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.

Condition	Intervention
Glucose Intolerance	Dietary Supplement: low feeding frequency (3x) Dietary Supplement: High feeding frequency (14x)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

Resource links provided by NLM:

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Glucose metabolism [ Time Frame: 24 hour profile ]
Insulin metabolism [ Time Frame: 24 hour profile ]

Secondary Outcome Measures:

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


Enrollment:	11
Study Start Date:	December 2010
Study Completion Date:	November 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

Lactose intolerant
Diabetes Mellitus
Cardiovascular diseases
Stomach and intestinal diseases
Normal glucose levels after 2 hours
Anticoagulants
Medication that has a effect on energy and glucose homeostasis and absorption of foods
Conditions or situations when subjects can't lose 500 ml blood

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456754

Locations


Netherlands
University of Maastricht
Maastricht, Netherlands

Sponsors and Collaborators

Maastricht University Medical Center

Nederlandse Zuivel Organisatie

Investigators


Principal Investigator:	Wim Saris, Prof. MD	Maastricht University

More Information


Responsible Party:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT01456754 History of Changes
Other Study ID Numbers:	MEC 10-3-057
First Submitted:	September 26, 2011
First Posted:	October 21, 2011
Last Update Posted:	December 15, 2011
Last Verified:	December 2011

Keywords provided by Maastricht University Medical Center:


Insulin Metabolism Glucose Metabolism Substrate Partitioning	Muscle Biopsies Feeding Frequency Insulin

Additional relevant MeSH terms:


Glucose Intolerance Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases	Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

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