Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype — POMFAME  

Overweight and Obesity Clinical Trial

Official title: Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype (POMFAME)

Status Completed

Clinical Trial Summary

The overall aim of this 12-week randomized controlled trial is to investigate if a dietary fiber supplement rich in arabinoxylans (AX) affects weight loss success differently according to baseline gut microbiota composition in subjects who have overweight or obesity.

105 participants will be randomized in a 2:1 ratio to receive 15 g/day of AX or placebo.

Clinical Trial Description

First, we hypothesize that participants who have a predominantly Prevotella enterotype (inferred by a high Prevotella/Bacteroides-ratio) will lose more body weight after AX supplementation compared to participants with a predominantly Bacteroides enterotype (inferred by a low Prevotella/Bacteroides-ratio). Specifically, we hypothesize that weight loss and P/B-ratio will be positively correlated in the AX supplementation-group whereas there will be no such correlation in the control-group. Consequently, we hypothesize that participants with the Bacteroides enterotype - and the lowest P/B-ratio - will have no benefit after AX supplementation while the weight loss effect of the AX supplementation will increase with increasing P/B-ratio.

Second, we hypothesize that the ability to digest starch in the upper gastrointestinal tract

• evaluated by salivary alpha amylase gene (AMY1) copy number - will influence the interactions among AX intake, P/B ratio, and body weight change. Specifically, we hypothesize that there will be an association between body weight change and P/B ratio among subjects with a low AMY1 copy number, but not among the ones with a high AMY1 copy number, when consuming AX. ;

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

• NCT number: NCT05260762
• Study type: Interventional
• Source: University of Copenhagen
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Completion date: June 13, 2023