- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034293
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning
July 22, 2010 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 ER
- 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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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:
- Lactose intolerant
- Diabetes Mellitus
- Hypertension
- Hypotension
- Cardiovascular diseases
- Asthma and other obstructive pulmonary diseases
- Elevated fasting blood glucose level
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low feeding frequency (3x)
|
3 meals a day
|
|
Experimental: High feeding frequency (14x)
|
14 meals a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glucose and insulin metabolism
Time Frame: 24 h
|
24 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Substrate partitioning and metabolic markers
Time Frame: 24 h
|
24 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: WHM Saris, Prof. Dr., Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 16, 2009
First Posted (Estimate)
December 17, 2009
Study Record Updates
Last Update Posted (Estimate)
July 23, 2010
Last Update Submitted That Met QC Criteria
July 22, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- MEC 09-3-032
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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