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OpenTrials
Completed

NCT Number: NCT05260762

Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arabinoxylan

Dietary Supplement

Dietary fiber product

Control

Dietary Supplement

Potato starch

Primary outcomes

  1. Body weight change

    Time frame: Baseline to week 12

    Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg

Secondary outcomes

  1. Body fat change

    Time frame: Baseline to week 12

    Evaluated by use of Dual X-ray absorptiometry (DXA) scans

  2. Fecal microbiota composition

    Time frame: Baseline to week 12

    Changes in relative abundance of gut bacteria

  3. Blood glucose metabolism

    Time frame: Baseline to week 12

    Fasting plasma glucose (and insulin) concentrations

  4. Resting energy expenditure

    Time frame: Baseline to week 12

    Indirect calorimetry with canopy mode

Other outcomes

  1. Blood Pressure

    Time frame: Baseline to week 12

    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.

  2. Blood cholesterol concentration

    Time frame: Baseline to week 12

    Total, LDL and HDL concentrations

  3. Appetite regulating hormones

    Time frame: Baseline to week 12

    ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)

  4. Fecal consistency

    Time frame: Baseline to week 12

    Assessment of fecal consistency by 3-day records

  5. Energy and macronutrient intake

    Time frame: Baseline to week 12

    Assessment of dietary intake by 3-day dietary records

  6. Subjective gastrointestinal (GI) symptoms

    Time frame: Baseline to week 12

    Assessment of subjective GI symptoms via visual analogue scales [1 (low) to 10 (high)]

  7. Subjective appetite sensation

    Time frame: Baseline to week 12

    Assessment of subjective appetite sensation via visual analogue scales [1 (low) to 10 (high)]

  8. Assessment of Brown Adipose Tissue (BAT) activity

    Time frame: Baseline to week 12

    Thermographic camera

  9. Fecal energy concentration

    Time frame: Baseline to week 12

    By bomb calorimeter

  10. Urine metabolome

    Time frame: Baseline to week 12

    Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of urine samples

  11. Fecal metabolome

    Time frame: Baseline to week 12

    Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF

  12. Plasma metabolome

    Time frame: Baseline to week 12

    Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: POMFAME

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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