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Effects the Glycemic Index on Metabolic Risk Markers

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Low GI+high GI
High GI+low GI
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome X

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy and obese men

Exclusion Criteria:

  • smoking

Sites / Locations

  • University Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A1

A2

Arm Description

Consumption of low GI food product on day 1 Consumption of high GI food product on day 2

Consumption of high GI food product on day 1 Consumption of low GI food product on day 2

Outcomes

Primary Outcome Measures

inflammation markers

Secondary Outcome Measures

glucose response

Full Information

First Posted
June 4, 2008
Last Updated
April 25, 2018
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00695825
Brief Title
Effects the Glycemic Index on Metabolic Risk Markers
Official Title
Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2006 (Actual)
Primary Completion Date
November 30, 2006 (Actual)
Study Completion Date
December 31, 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recent population studies have shown that the glycemic index (GI) of food products is positively associated with the risk of developing type 2 diabetes and cardiovascular disease (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of developing the metabolic syndrome. People, however, spent most of their time in the postprandial period. Therefore, there is a need to study the postprandial effects of low-GI vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in lean subjects, while especially overweight and obese people suffer from metabolic aberrations related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A second research objective is to compare these effects with those in lean subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Description
Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
Arm Title
A2
Arm Type
Experimental
Arm Description
Consumption of high GI food product on day 1 Consumption of low GI food product on day 2
Intervention Type
Dietary Supplement
Intervention Name(s)
Low GI+high GI
Intervention Description
Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
Intervention Type
Dietary Supplement
Intervention Name(s)
High GI+low GI
Intervention Description
Consumption of high GI food product on day 1 Consumption of low GI food product on day 2
Primary Outcome Measure Information:
Title
inflammation markers
Time Frame
postprandial effect
Secondary Outcome Measure Information:
Title
glucose response
Time Frame
postprandial

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy and obese men Exclusion Criteria: smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Vrolix, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Maastricht
City
Maastricht
ZIP/Postal Code
6229 ER
Country
Netherlands

12. IPD Sharing Statement

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Effects the Glycemic Index on Metabolic Risk Markers

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