Effects the Glycemic Index on Metabolic Risk Markers

NCT ID: NCT00695825

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-01
• Study Completion Date: 2008-12-31

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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A1

Consumption of low GI food product on day 1 Consumption of high GI food product on day 2

Group Type: EXPERIMENTAL

Low GI+high GI

Intervention Type: DIETARY_SUPPLEMENT

Consumption of low GI food product on day 1 Consumption of high GI food product on day 2

A2

Consumption of high GI food product on day 1 Consumption of low GI food product on day 2

Group Type: EXPERIMENTAL

High GI+low GI

Intervention Type: DIETARY_SUPPLEMENT

Consumption of high GI food product on day 1 Consumption of low GI food product on day 2

Interventions

Low GI+high GI

Consumption of low GI food product on day 1 Consumption of high GI food product on day 2

Intervention Type: DIETARY_SUPPLEMENT

High GI+low GI

Consumption of high GI food product on day 1 Consumption of low GI food product on day 2

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• healthy and obese men

Exclusion Criteria

• smoking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Maastricht University

Principal Investigators

Ruth Vrolix, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

University Maastricht

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

073101

Identifier Type: -

Identifier Source: org_study_id