Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
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ClinicalTrials.gov Identifier: NCT01456754 |
Recruitment Status
:
Completed
First Posted
: October 21, 2011
Last Update Posted
: December 15, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glucose Intolerance | Dietary Supplement: low feeding frequency (3x) Dietary Supplement: High feeding frequency (14x) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
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
|
- Glucose metabolism [ Time Frame: 24 hour profile ]
- Insulin metabolism [ Time Frame: 24 hour profile ]
- Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets [ Time Frame: 24 hour profiles ]
- Metabolic markers (FFA and TG metabolism) [ Time Frame: 24 hour profile ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456754
Netherlands | |
University of Maastricht | |
Maastricht, Netherlands |
Principal Investigator: | Wim Saris, Prof. MD | Maastricht University |
Responsible Party: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT01456754 History of Changes |
Other Study ID Numbers: |
MEC 10-3-057 |
First Posted: | October 21, 2011 Key Record Dates |
Last Update Posted: | December 15, 2011 |
Last Verified: | December 2011 |
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 |