NCT01731366

The Effect of Whole Grain on Gut Microbiome and Metabolic Health

Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health . Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included. Intervention: low vs. high whole grain intake.

Detailed description

The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a diet rich in whole grain in the active treatment period and a refined grain diet during the control period. Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.

Conditions

• Metabolic Disease
• Injury of Gastrointestinal Tract

Interventions

Type	Name	Description
OTHER	Whole grain	Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)
OTHER	Refined grain	Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-02-01
• Completion: 2015-12-01
• First posted: 2012-11-21
• Last updated: 2014-09-03

Locations

1 site across 1 country: Denmark