Fecal Fat IncreasedPOFIBANCT02957318
Effect of Potato Fiber on Appetite and Fecal Fat Excretion
A study testing FiberBind and RG-I fiber in people with Fecal Fat Increased and Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Results have indicated that some dietary fibers increase fecal fat excretion and particularly viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may contribute to body weight management. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fecal Fat Increased, Obesity, Appetite
- What is being tested?
- FiberBind and RG-I fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to 31 Mar 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Men
- BMI between 18.5 and 27.0 kg/m2
- Age 20-40 years
Who cannot join
- Intake of potatoes with main meals more frequent than 4 times per week
- Chronic diseases (known diabetes, cardiovascular disease, irritable bowels disease, colitis ulcerosa, crohn disease, or other chronic diseases which could affect the results of the present study)
- Gluten allergy
- Use of daily prescription medicine (mild analgesics are allowed)
- Use of lipid-lowering agents (e.g. Becel, HUSK)
- Use of food supplements of relevance to the study (such as pre- and probiotics)
Show all 12Show fewer
- Irregular intake of vitamin /mineral supplements (two weeks prior to and during the entire study period)
- Smoking
- Elite athletes (>10 hours of strenuous physical activity per week)
- Blood donation (<1 month before study commencement and during study period)
- Participation in other clinical studies (<1 month before study commencement and during study period)
- Inability (physically or psychologically) to comply with the procedures required by the protocol judged by the Investigator
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, 1958
About this study
Results have indicated that some dietary fibers increase fecal fat excretion and particularly viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may contribute to body weight management.
Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of secondary endpoints are investigated.
- Conditions
- Fecal Fat Increased, Obesity, Appetite
- Being tested
- FiberBind, RG-I fiber, Placebo
- Medical subject headings
- Steatorrhea, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberBindDietary supplement
Potato pulp consisting of 68% fiber (5.5 soluble, 76.7% insoluble and 17.8% resistant starch), 9.7% water, 0.3% fat, 7.2% protein and 14% carbohydrates (starch).
RG-I fiberDietary supplement
Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.
PlaceboDietary supplement
Low-fiber control
| Study group | Role | What they receive |
|---|---|---|
| FiberBind | Experimental | Not described Receives: Dietary Supplement: FiberBind |
| RG-I fiber | Experimental | Not described Receives: Dietary Supplement: RG-I fiber |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal fat excretion
Measured: Based on total feces collection the last 3 days of the 21-day intervention periods
Subjective appetite sensations
Assessed by visual analogue scales (VAS)
Measured: Assessed on 3-hour meal test on last day of the 21-day intervention periods
Secondary outcomes (11)
Ad libitum energy intake
Measured: Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods
Fecal energy excretion
Measured: Measured based on total feces collection the last 3 days of the 21-day intervention periods
Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)
Measured: Measured before and after the 21-day intervention periods
Insulin and glucose
Measured: Measured before and after the 21-day intervention periods, and every 30 minutes during the 3-hour meal test on last day of the 21-week intervention periods
Gut permeability marker
Measured: Measured before and after the 21-day intervention periods
Gastric emptying rate (w. paracetamol)
Measured: Measured every 30 minutes during the 3-hour meal test on last day of the 21-day intervention periods
Gastrointestinal symptoms (questionnaire)
Measured: on day 1, 7, 14 and 22 of the 21-day intervention periods
Body weight
Measured: up to 21-day intervention periods
Blood pressure
Measured: up to 21-day intervention periods
Breath hydrogen
Measured: up to 21-day intervention periods
Gut microbiota
Measured: Measured in a fresh feces sample from day 19-21 of the intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Fat IncreasedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Birgitte Raben, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957318
- Sponsor's protocol ID
- B 326
- Acronym
- POFIBA
- Status last verified
- May 2017
- First submitted
- 1 Nov 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Potato Fiber on Appetite and Fecal Fat Excretion
- ClinicalTrials.gov ID
- NCT02957318
- Acronym / sponsor ID
- POFIBA / B 326
- Conditions
- Fecal Fat Increased, Obesity, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
Results have indicated that some dietary fibers increase fecal fat excretion and particularly viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may contribute to body weight management.
Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of secondary endpoints are investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FiberBind | Experimental | Dietary Supplement: FiberBind |
| RG-I fiber | Experimental | Dietary Supplement: RG-I fiber |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Men
- BMI between 18.5 and 27.0 kg/m2
- Age 20-40 years
Key exclusion criteria (12 listed)
- Intake of potatoes with main meals more frequent than 4 times per week
- Chronic diseases (known diabetes, cardiovascular disease, irritable bowels disease, colitis ulcerosa, crohn disease, or other chronic diseases which could affect the results of the present study)
- Gluten allergy
- Use of daily prescription medicine (mild analgesics are allowed)
- Use of lipid-lowering agents (e.g. Becel, HUSK)
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 |
|---|---|---|
| FiberBindPotato pulp consisting of 68% fiber (5.5 soluble, 76.7% insoluble and 17.8% resistant starch), 9.7% water, 0.3% fat, 7.2% protein and 14% carbohydrates (starch). | Dietary supplement | FiberBind |
| RG-I fiberSoluble fiber extracted from potato pulp consisting of 95% fiber and 5% water. | Dietary supplement | RG-I fiber |
| PlaceboLow-fiber control | Dietary supplement | Placebo |
Primary outcome
Fecal fat excretion
Time frame: Based on total feces collection the last 3 days of the 21-day intervention periods
Subjective appetite sensations
Time frame: Assessed on 3-hour meal test on last day of the 21-day intervention periods
Assessed by visual analogue scales (VAS)
11 secondary outcomes
Ad libitum energy intake
Time frame: Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods
Fecal energy excretion
Time frame: Measured based on total feces collection the last 3 days of the 21-day intervention periods
Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)
Time frame: Measured before and after the 21-day intervention periods
Insulin and glucose
Time frame: Measured before and after the 21-day intervention periods, and every 30 minutes during the 3-hour meal test on last day of the 21-week intervention periods
Gut permeability marker
Time frame: Measured before and after the 21-day intervention periods
Gastric emptying rate (w. paracetamol)
Time frame: Measured every 30 minutes during the 3-hour meal test on last day of the 21-day intervention periods
Gastrointestinal symptoms (questionnaire)
Time frame: on day 1, 7, 14 and 22 of the 21-day intervention periods
Body weight
Time frame: up to 21-day intervention periods
Blood pressure
Time frame: up to 21-day intervention periods
Breath hydrogen
Time frame: up to 21-day intervention periods
Gut microbiota
Time frame: Measured in a fresh feces sample from day 19-21 of the intervention periods
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 13 Sep 2017.
Related trials for Fecal Fat Increased
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
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 FiberBind and RG-I fiber in people with Fecal Fat Increased and Obesity, 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 3 inclusion and 12 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 13 Sep 2017. 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?
Fecal fat excretion (time frame: Based on total feces collection the last 3 days of the 21-day intervention periods). The study lists 2 primary outcomes in all. 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 13 Sep 2017.