Effects the Glycemic Index on Metabolic Risk Markers

NCT00695825 | Completed DMC

• 1 other identifier: 073101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• inflammation markers

  postprandial effect

Secondary Outcomes (1)

• glucose response

  postprandial

Study Arms (2)

A1

EXPERIMENTAL

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

Dietary Supplement: Low GI+high GI

A2

EXPERIMENTAL

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

Dietary Supplement: High GI+low GI

Interventions

Low GI+high GI DIETARY_SUPPLEMENT

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

A1

High GI+low GI DIETARY_SUPPLEMENT

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

A2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy and obese men

You may not qualify if:

• smoking

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

University Maastricht

Maastricht, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ruth Vrolix, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 12, 2008
• Study Start: April 1, 2006
• Primary Completion: November 30, 2006
• Study Completion: December 31, 2008
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

NL (1)