Effects the Glycemic Index on Metabolic Risk Markers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00695825
First received: June 4, 2008
Last updated: December 11, 2008
Last verified: December 2008
  Purpose

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 (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose response [ Time Frame: postprandial ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy and obese men

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Ronald P. Mensink, Prof., Maastricht University
ClinicalTrials.gov Identifier: NCT00695825     History of Changes
Other Study ID Numbers: 073101
Study First Received: June 4, 2008
Last Updated: December 11, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on August 20, 2014