Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
This study has been completed.
Sponsor:
Maastricht University Medical Center
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
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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 (Adult, Senior) |
| 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:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01456754
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
| 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, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016