Effect of Potato Fiber on Appetite and Fecal Fat Excretion (POFIBA)

September 12, 2017 updated by: Anne Birgitte Raben, University of Copenhagen

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

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 1958
        • University of Copenhagen, Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Low-fiber control
Experimental: FiberBind
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).
Experimental: RG-I fiber
Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.

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
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)
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
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
Blood pressure
Time Frame: up to 21-day intervention periods
up to 21-day intervention periods
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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