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Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning

This study has been completed.
Sponsor:
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01034293
First received: December 16, 2009
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.


Condition Intervention
Insulin
Glucose Metabolism
 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glucose and insulin metabolism [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Substrate partitioning and metabolic markers [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low feeding frequency (3x) Dietary Supplement: low feeding frequency (3x)
3 meals a day
Experimental: High feeding frequency (14x) Dietary Supplement: High feeding frequency (14x)
14 meals a day

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI: 18.5-25 kg/m2 (lean)
  • Gender: Male
  • Age: subjects has to be older than 18 and including 35 years old
  • Caucasian

Exclusion Criteria:

  • Metabolic abnormalities such as:

    1. Lactose intolerant
    2. Diabetes Mellitus
    3. Hypertension
    4. Hypotension
    5. Cardiovascular diseases
    6. Asthma and other obstructive pulmonary diseases
    7. Elevated fasting blood glucose level
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034293

Locations
Netherlands
University of Maastricht
Maastricht, Limburg, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
Nederlandse Zuivel Organisatie
Investigators
Principal Investigator: WHM Saris, Prof. Dr. Maastricht University
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. dr. WHM Saris, University of Maastricht
ClinicalTrials.gov Identifier: NCT01034293     History of Changes
Other Study ID Numbers: MEC 09-3-032
Study First Received: December 16, 2009
Last Updated: July 22, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
feeding frequency
insulin metabolism
glucose metabolism
substrate partitioning

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013