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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

June 4, 2008
December 11, 2008
February 2008
November 2008   (final data collection date for primary outcome measure)
inflammation markers [ Time Frame: postprandial effect ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00695825 on ClinicalTrials.gov Archive Site
glucose response [ Time Frame: postprandial ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects the Glycemic Index on Metabolic Risk Markers
Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Metabolic Syndrome X
  • Dietary Supplement: Low GI+high GI
    Consumption of low GI food product on day 1 Consumption of high 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
  • Experimental: A1
    Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
    Intervention: Dietary Supplement: Low GI+high GI
  • Experimental: A2
    Consumption of high GI food product on day 1 Consumption of low GI food product on day 2
    Intervention: Dietary Supplement: High GI+low GI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy and obese men

Exclusion Criteria:

  • smoking
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00695825
073101
Yes
Ronald P. Mensink, Prof., Maastricht University
Maastricht University Medical Center
Not Provided
Principal Investigator: Ruth Vrolix, PhD Maastricht University
Maastricht University Medical Center
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP