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Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
low feeding frequency (3x)
High feeding frequency (14x)
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glucose Intolerance focused on measuring Insulin Metabolism, Glucose Metabolism, Substrate Partitioning, Muscle Biopsies, Feeding Frequency, Insulin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

  1. Lactose intolerant
  2. Diabetes Mellitus
  3. Cardiovascular diseases
  4. Stomach and intestinal diseases
  5. Normal glucose levels after 2 hours
  6. Anticoagulants
  7. Medication that has a effect on energy and glucose homeostasis and absorption of foods
  8. Conditions or situations when subjects can't lose 500 ml blood

Sites / Locations

  • University of Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High feeding frequency (14x)

low feeding frequency (3x)

Arm Description

Outcomes

Primary Outcome Measures

Glucose metabolism
Insulin metabolism

Secondary Outcome Measures

Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
Metabolic markers (FFA and TG metabolism)

Full Information

First Posted
September 26, 2011
Last Updated
December 14, 2011
Sponsor
Maastricht University Medical Center
Collaborators
Nederlandse Zuivel Organisatie
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1. Study Identification

Unique Protocol Identification Number
NCT01456754
Brief Title
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
Official Title
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Nederlandse Zuivel Organisatie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance
Keywords
Insulin Metabolism, Glucose Metabolism, Substrate Partitioning, Muscle Biopsies, Feeding Frequency, Insulin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High feeding frequency (14x)
Arm Type
Experimental
Arm Title
low feeding frequency (3x)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
low feeding frequency (3x)
Intervention Description
3 meals a day
Intervention Type
Dietary Supplement
Intervention Name(s)
High feeding frequency (14x)
Intervention Description
14 meals a day
Primary Outcome Measure Information:
Title
Glucose metabolism
Time Frame
24 hour profile
Title
Insulin metabolism
Time Frame
24 hour profile
Secondary Outcome Measure Information:
Title
Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets
Time Frame
24 hour profiles
Title
Metabolic markers (FFA and TG metabolism)
Time Frame
24 hour profile

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Saris, Prof. MD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maastricht
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

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Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

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