NCT02519127

Metflex: The Effectiveness of a Dietary Intervention

Employing Dynamic Kinetic Responses to Demonstrate the Effectiveness of Dietary Intervention: A Challenge-based Study Using a Low-glycaemic Load Diet

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is testing the effectiveness of a dietary intervention by means of measuring the change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring the kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge before and after a 6-week dietary intervention. The challenges will be applied to investigate whether the kinetic response is a better measure for health and wellbeing when compared to fasting (baseline) levels. In addition, several measures that reflect perceivable benefits like mood, quality of life, sleep quality, cognitive and physical performance will be assessed in a first exploratory attempt to link (changes in) PF to consumer perceivable benefits. Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6 weeks. Before and after the intervention several measurements will take place. The low glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and nuts, and low in glycemic carbohydrates. All these dietary factors have been shown to improve glycemic control and/or to reduce metabolic syndrome risk factors.

Conditions

• Metabolic Flexibility

Interventions

Type	Name	Description
OTHER	Low glycaemic load diet	Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a low glycemic load diet for 6 weeks.
OTHER	Western diet	Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a 'Western' diet for 6 weeks.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-05-12
• Completion: 2017-05-12
• First posted: 2015-08-10
• Last updated: 2017-11-09

Locations

1 site across 1 country: Netherlands