Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype (POMFAME)
Primary Purpose
Overweight and Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Arabinoxylan
Control
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Gut microbiota, Dietary fiber
Eligibility Criteria
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
Sites / Locations
- University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Arabinoxylan
Control
Arm Description
Arabinoxylan (15 g AX/d) wheat buns
Non-fiber, carbohydrate control (15 g /d) wheat buns
Outcomes
Primary Outcome Measures
Body weight change
Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg
Secondary Outcome Measures
Body fat change
Evaluated by use of Dual X-ray absorptiometry (DXA) scans
Fecal microbiota composition
Changes in relative abundance of gut bacteria
Blood glucose metabolism
Fasting plasma glucose (and insulin) concentrations
Resting energy expenditure
Indirect calorimetry with canopy mode
Full Information
NCT ID
NCT05260762
First Posted
January 10, 2022
Last Updated
June 21, 2023
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT05260762
Brief Title
Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype
Acronym
POMFAME
Official Title
Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype (POMFAME)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
June 13, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Weight Loss
Keywords
Gut microbiota, Dietary fiber
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arabinoxylan
Arm Type
Active Comparator
Arm Description
Arabinoxylan (15 g AX/d) wheat buns
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Non-fiber, carbohydrate control (15 g /d) wheat buns
Intervention Type
Dietary Supplement
Intervention Name(s)
Arabinoxylan
Intervention Description
Dietary fiber product
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Potato starch
Primary Outcome Measure Information:
Title
Body weight change
Description
Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Body fat change
Description
Evaluated by use of Dual X-ray absorptiometry (DXA) scans
Time Frame
Baseline to week 12
Title
Fecal microbiota composition
Description
Changes in relative abundance of gut bacteria
Time Frame
Baseline to week 12
Title
Blood glucose metabolism
Description
Fasting plasma glucose (and insulin) concentrations
Time Frame
Baseline to week 12
Title
Resting energy expenditure
Description
Indirect calorimetry with canopy mode
Time Frame
Baseline to week 12
Other Pre-specified Outcome Measures:
Title
Blood Pressure
Description
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.
Time Frame
Baseline to week 12
Title
Blood cholesterol concentration
Description
Total, LDL and HDL concentrations
Time Frame
Baseline to week 12
Title
Appetite regulating hormones
Description
ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)
Time Frame
Baseline to week 12
Title
Fecal consistency
Description
Assessment of fecal consistency by 3-day records
Time Frame
Baseline to week 12
Title
Energy and macronutrient intake
Description
Assessment of dietary intake by 3-day dietary records
Time Frame
Baseline to week 12
Title
Subjective gastrointestinal (GI) symptoms
Description
Assessment of subjective GI symptoms via visual analogue scales [1 (low) to 10 (high)]
Time Frame
Baseline to week 12
Title
Subjective appetite sensation
Description
Assessment of subjective appetite sensation via visual analogue scales [1 (low) to 10 (high)]
Time Frame
Baseline to week 12
Title
Assessment of Brown Adipose Tissue (BAT) activity
Description
Thermographic camera
Time Frame
Baseline to week 12
Title
Fecal energy concentration
Description
By bomb calorimeter
Time Frame
Baseline to week 12
Title
Urine metabolome
Description
Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of urine samples
Time Frame
Baseline to week 12
Title
Fecal metabolome
Description
Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF
Time Frame
Baseline to week 12
Title
Plasma metabolome
Description
Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF
Time Frame
Baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Copenhagen
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
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Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype
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