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

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ClinicalTrials.gov Identifier: NCT01456754
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : December 15, 2011
Sponsor:
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Glucose Intolerance Dietary Supplement: low feeding frequency (3x) Dietary Supplement: High feeding frequency (14x) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Glucose metabolism [ Time Frame: 24 hour profile ]
  2. Insulin metabolism [ Time Frame: 24 hour profile ]

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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:

  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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01456754     History of Changes
Other Study ID Numbers: MEC 10-3-057
First Posted: October 21, 2011    Key Record Dates
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