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

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Arabinoxylan; Dietary supplement: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1958
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Apparently healthy men or women (self-reported nonpregnant, nonlactating, and not planning a pregnancy in the next 4 months)
• BMI: 25 to 40 kg/m2
• Non-smoker
• Want to maintain or lose weight
• Willing to consume wheat buns on a daily basis

Exclusion Criteria:

• Consumption of whole grain products with every meal
• Use of antibiotics 60 days prior to the start of the study. If a participant uses antibiotics prior to randomization, they will be invited to be re-screened 3 months after the last use of antibiotics, provided that it is realistic to complete the study no later than the scheduled LPLV
• Dietary supplements with pro- and/or prebiotics 6 weeks prior to study
• Self-reported eating disorders
• Being a bodybuilder (>4 strength training sessions per week)
• Alcohol intake above the recommendation from the Danish Health and Medicines Authority (>21 units of alcohol per week)
• Night- or shift work
• Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, thyroid disease, cardiovascular disease, type 1 or 2 diabetes, inflammatory diseases, and celiac disease
• Disorders: neurological, sleep, diagnosed psychiatric disorder and gastrointestinal and liver disorders
• Surgical treatment of obesity and abdominal surgery
• Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible
• Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible
• Simultaneous blood donation for another purpose than this study
• Simultaneous participation in other clinical intervention studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arabinoxylan; Arabinoxylan (15 g AX/d) wheat buns	Dietary supplement: Arabinoxylan; Dietary fiber product
Placebo Comparator: Control; Non-fiber, carbohydrate control (15 g /d) wheat buns	Dietary supplement: Control; Potato starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight change	Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat change	Evaluated by use of Dual X-ray absorptiometry (DXA) scans	Baseline to week 12
Fecal microbiota composition	Changes in relative abundance of gut bacteria	Baseline to week 12
Blood glucose metabolism	Fasting plasma glucose (and insulin) concentrations	Baseline to week 12
Resting energy expenditure	Indirect calorimetry with canopy mode	Baseline to week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Systolic and diastolic blood pressure and pulse rate will be measured using a validated automatic device on the arm after 5-10 min rest in a resting position.	Baseline to week 12
Blood cholesterol concentration	Total, LDL and HDL concentrations	Baseline to week 12
Appetite regulating hormones	ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)	Baseline to week 12
Fecal consistency	Assessment of fecal consistency by 3-day records	Baseline to week 12
Energy and macronutrient intake	Assessment of dietary intake by 3-day dietary records	Baseline to week 12
Subjective gastrointestinal (GI) symptoms	Assessment of subjective GI symptoms via visual analogue scales [1 (low) to 10 (high)]	Baseline to week 12
Subjective appetite sensation	Assessment of subjective appetite sensation via visual analogue scales [1 (low) to 10 (high)]	Baseline to week 12
Assessment of Brown Adipose Tissue (BAT) activity	Thermographic camera	Baseline to week 12
Fecal energy concentration	By bomb calorimeter	Baseline to week 12
Urine metabolome	Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of urine samples	Baseline to week 12
Fecal metabolome	Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF	Baseline to week 12
Plasma metabolome	Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF	Baseline to week 12

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Gut microbiota; Dietary fiber
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Obesity; Weight Loss; Overweight
• Other Study ID Numbers: B-360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No