- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957318
Effect of Potato Fiber on Appetite and Fecal Fat Excretion (POFIBA)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 1958
- University of Copenhagen, Department of Nutrition, Exercise and Sports
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy Men
- BMI between 18.5 and 27.0 kg/m2
- Age 20-40 years
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Low-fiber control
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Experimental: FiberBind
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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).
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Experimental: RG-I fiber
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Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal fat excretion
Time Frame: Based on total feces collection the last 3 days of the 21-day intervention periods
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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)
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Assessed on 3-hour meal test on last day of the 21-day intervention periods
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ad libitum energy intake
Time Frame: Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods
|
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
|
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
|
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
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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
|
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
|
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
|
on day 1, 7, 14 and 22 of the 21-day intervention periods
|
Body weight
Time Frame: up to 21-day intervention periods
|
up to 21-day intervention periods
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Blood pressure
Time Frame: up to 21-day intervention periods
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up to 21-day intervention periods
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Breath hydrogen
Time Frame: up to 21-day intervention periods
|
up to 21-day intervention periods
|
Gut microbiota
Time Frame: Measured in a fresh feces sample from day 19-21 of the intervention periods
|
Measured in a fresh feces sample from day 19-21 of the intervention periods
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B 326
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