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
About this trial
This is an interventional prevention trial for Metabolic Syndrome X
Eligibility Criteria
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
NCT ID
NCT00695825
First Posted
June 4, 2008
Last Updated
April 25, 2018
Sponsor
Maastricht University Medical Center
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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