Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism — PRIMA-KOST  

Metabolic Disease Clinical Trial

Official title: Effects of Changing Intestinal Transit Time on Gut Microbial Composition and Metabolism During a Dietary Intervention With Low and High Fiber.

Status Recruiting

Clinical Trial Summary

The aim of this study is to investigate how a short versus a long transit time impacts the gut microbiome's response to a high-fiber and a low-fiber diet, respectively. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.

Clinical Trial Description

The study consists of two parallel arms of whole-meal diets, a low-fiber diet, and a high-fiber diet, respectively. Each arm is designed as a cross-over where participants, in random order, are administered a laxative (Movicol) along with the provided diet to shorten their intestinal transit time or simply consume the provided whole-meal diet (control).

The two intervention periods both involve the following:

• One week of run-in where participants consume the provided whole-meal diet.

• One week where participants either consume Movicol with the provided whole-meal diet or simply continue consuming the provided whole-meal diet (control).

Both arms begin with a screening visit and one week where participants consume and record their habitual diets. Subsequently, the first intervention period follows with one visit before and after each of the two weeks (visit 1-3) followed by the second intervention period with one visit before and after each of the two weeks (visit 4-6). The two cross-over periods are split by a washout of at least two weeks.

The study thus runs for approximately 7-8 weeks depending on the length of the washout and consists of seven visits (one screening visit and six regular visits) in total. ;

Related Conditions & MeSH terms

• Diet, Healthy
• Metabolic Disease
• Metabolic Diseases

• NCT number: NCT06022302
• Study type: Interventional
• Source: University of Copenhagen
• Contact: Henrik M Roager, PhD
• Phone: +4535324928
• Email: hero@nexs.ku.dk
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Completion date: January 2030