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Effects the Glycemic Index on Metabolic Risk Markers

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ClinicalTrials.gov Identifier: NCT00695825
Recruitment Status : Unknown
Verified December 2008 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2008
Last Update Posted : December 12, 2008
Sponsor:
Information provided by:
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Dietary Supplement: Low GI+high GI Dietary Supplement: High GI+low GI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : February 2008
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. glucose response [ Time Frame: postprandial ]


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

Inclusion Criteria:

  • healthy and obese men

Exclusion Criteria:

  • smoking

Information from the National Library of Medicine

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): NCT00695825


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

Responsible Party: Ronald P. Mensink, Prof., Maastricht University
ClinicalTrials.gov Identifier: NCT00695825     History of Changes
Other Study ID Numbers: 073101
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: December 12, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases