Overweight and ObesityPOMFAMENCT05260762
Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype
A study testing Arabinoxylan in people with Overweight and Obesity and Weight Loss, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Weight Loss
- What is being tested?
- Arabinoxylan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Apr 2022to 13 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Weight Loss
- Being tested
- Arabinoxylan, Control
- Keywords
- Gut microbiota, Dietary fiber
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArabinoxylanDietary supplement
Dietary fiber product
ControlDietary supplement
Potato starch
| Study group | Role | What they receive |
|---|---|---|
| Arabinoxylan | Active comparator | Arabinoxylan (15 g AX/d) wheat buns Receives: Dietary Supplement: Arabinoxylan |
| Control | Placebo comparator | Non-fiber, carbohydrate control (15 g /d) wheat buns Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg
Measured: Baseline to week 12
Secondary outcomes (4)
Body fat change
Evaluated by use of Dual X-ray absorptiometry (DXA) scans
Measured: Baseline to week 12
Fecal microbiota composition
Changes in relative abundance of gut bacteria
Measured: Baseline to week 12
Blood glucose metabolism
Fasting plasma glucose (and insulin) concentrations
Measured: Baseline to week 12
Resting energy expenditure
Indirect calorimetry with canopy mode
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start13 Apr 2022
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faidon Magkos, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260762
- Sponsor's protocol ID
- B-360
- Acronym
- POMFAME
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype (POMFAME)
- ClinicalTrials.gov ID
- NCT05260762
- Acronym / sponsor ID
- POMFAME / B-360
- Conditions
- Overweight and Obesity, Weight Loss
- Keywords
- Gut microbiota, Dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arabinoxylan | Active comparator | Dietary Supplement: ArabinoxylanArabinoxylan (15 g AX/d) wheat buns |
| Control | Placebo comparator | Dietary Supplement: ControlNon-fiber, carbohydrate control (15 g /d) wheat buns |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArabinoxylanDietary fiber product | Dietary supplement | Arabinoxylan |
| ControlPotato starch | Dietary supplement | Control |
Primary outcome
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
4 secondary outcomes
Body fat change
Time frame: Baseline to week 12
Fecal microbiota composition
Time frame: Baseline to week 12
Blood glucose metabolism
Time frame: Baseline to week 12
Resting energy expenditure
Time frame: Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arabinoxylan in people with Overweight and Obesity and Weight Loss, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.