Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 15, 2011
December 1, 2011
9 months
September 26, 2011
December 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glucose metabolism
24 hour profile
Insulin metabolism
24 hour profile
Secondary Outcomes (2)
Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
24 hour profiles
Metabolic markers (FFA and TG metabolism)
24 hour profile
Study Arms (2)
High feeding frequency (14x)
EXPERIMENTALlow feeding frequency (3x)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maastricht
Maastricht, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wim Saris, Prof. MD
Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2011
First Posted
October 21, 2011
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
November 1, 2011
Last Updated
December 15, 2011
Record last verified: 2011-12