Effects the Glycemic Index on Metabolic Risk Markers

Metabolic Syndrome X Clinical Trial

Official title:

Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695825
• Other study ID #: 073101
• Status: Completed
• Phase: N/A
• First received: June 4, 2008
• Last updated: April 25, 2018
• Start date: April 1, 2006
• Est. completion date: December 31, 2008

Study information

• Verified date: April 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2008
• Est. primary completion date: November 30, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy and obese men

Exclusion Criteria:

• smoking

Related Conditions & MeSH terms

• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Low GI+high GI
Consumption of low GI food product on day 1 Consumption of high GI food product on day 2
• High GI+low GI
Consumption of high GI food product on day 1 Consumption of low GI food product on day 2

Locations

Country	Name	City	State
Netherlands	University Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation markers		postprandial effect
Secondary	glucose response		postprandial