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

This study has been completed.
Sponsor:
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01456754
First received: September 26, 2011
Last updated: December 14, 2011
Last verified: December 2011
  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: 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:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glucose metabolism [ Time Frame: 24 hour profile ] [ Designated as safety issue: No ]
  • Insulin metabolism [ Time Frame: 24 hour profile ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets [ Time Frame: 24 hour profiles ] [ Designated as safety issue: No ]
  • Metabolic markers (FFA and TG metabolism) [ Time Frame: 24 hour profile ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01456754     History of Changes
Other Study ID Numbers: MEC 10-3-057
Study First Received: September 26, 2011
Last Updated: December 14, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014