Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype

Overweight and Obesity Clinical Trial

— POMFAME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260762
• Other study ID #: B-360
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: June 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Arabinoxylan
Dietary fiber product
• Control
Potato starch

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Blood cholesterol concentration	Total, LDL and HDL concentrations	Baseline to week 12
Other	Appetite regulating hormones	ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)	Baseline to week 12
Other	Fecal consistency	Assessment of fecal consistency by 3-day records	Baseline to week 12
Other	Energy and macronutrient intake	Assessment of dietary intake by 3-day dietary records	Baseline to week 12
Other	Subjective gastrointestinal (GI) symptoms	Assessment of subjective GI symptoms via visual analogue scales [1 (low) to 10 (high)]	Baseline to week 12
Other	Subjective appetite sensation	Assessment of subjective appetite sensation via visual analogue scales [1 (low) to 10 (high)]	Baseline to week 12
Other	Assessment of Brown Adipose Tissue (BAT) activity	Thermographic camera	Baseline to week 12
Other	Fecal energy concentration	By bomb calorimeter	Baseline to week 12
Other	Urine metabolome	Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of urine samples	Baseline to week 12
Other	Fecal metabolome	Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF	Baseline to week 12
Other	Plasma metabolome	Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF	Baseline to week 12
Primary	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	Body fat change	Evaluated by use of Dual X-ray absorptiometry (DXA) scans	Baseline to week 12
Secondary	Fecal microbiota composition	Changes in relative abundance of gut bacteria	Baseline to week 12
Secondary	Blood glucose metabolism	Fasting plasma glucose (and insulin) concentrations	Baseline to week 12
Secondary	Resting energy expenditure	Indirect calorimetry with canopy mode	Baseline to week 12