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Effects the Glycemic Index on Metabolic Risk Markers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by:
Maastricht University Medical Center Identifier:
First received: June 4, 2008
Last updated: December 11, 2008
Last verified: December 2008
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.

Condition Intervention
Metabolic Syndrome X
Dietary Supplement: Low GI+high GI
Dietary Supplement: High GI+low GI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • inflammation markers [ Time Frame: postprandial effect ]

Secondary Outcome Measures:
  • glucose response [ Time Frame: postprandial ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1
Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
Dietary Supplement: Low GI+high GI
Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
Experimental: A2
Consumption of high GI food product on day 1 Consumption of low GI food product on day 2
Dietary Supplement: High GI+low GI
Consumption of high GI food product on day 1 Consumption of low GI food product on day 2


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy and obese men

Exclusion Criteria:

  • smoking
  Contacts and Locations
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Please refer to this study by its identifier: NCT00695825

University Maastricht
Maastricht, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: Ruth Vrolix, PhD Maastricht University
  More Information

Responsible Party: Ronald P. Mensink, Prof., Maastricht University Identifier: NCT00695825     History of Changes
Other Study ID Numbers: 073101
Study First Received: June 4, 2008
Last Updated: December 11, 2008

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 25, 2017