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

Primary Purpose

Fecal Fat Increased, Obesity, Appetite

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
FiberBind
RG-I fiber
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fecal Fat Increased

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

FiberBind

RG-I fiber

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Fecal fat excretion
Subjective appetite sensations
Assessed by visual analogue scales (VAS)

Secondary Outcome Measures

Ad libitum energy intake
Fecal energy excretion
Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)
Insulin and glucose
Gut permeability marker
Gastric emptying rate (w. paracetamol)
Gastrointestinal symptoms (questionnaire)
Body weight
Blood pressure
Breath hydrogen
Gut microbiota

Full Information

First Posted
November 1, 2016
Last Updated
September 12, 2017
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02957318
Brief Title
Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Acronym
POFIBA
Official Title
Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Fat Increased, Obesity, Appetite

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FiberBind
Arm Type
Experimental
Arm Title
RG-I fiber
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
FiberBind
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
RG-I fiber
Intervention Description
Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Low-fiber control
Primary Outcome Measure Information:
Title
Fecal fat excretion
Time Frame
Based on total feces collection the last 3 days of the 21-day intervention periods
Title
Subjective appetite sensations
Description
Assessed by visual analogue scales (VAS)
Time Frame
Assessed on 3-hour meal test on last day of the 21-day intervention periods
Secondary Outcome Measure Information:
Title
Ad libitum energy intake
Time Frame
Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods
Title
Fecal energy excretion
Time Frame
Measured based on total feces collection the last 3 days of the 21-day intervention periods
Title
Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)
Time Frame
Measured before and after the 21-day intervention periods
Title
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
Title
Gut permeability marker
Time Frame
Measured before and after the 21-day intervention periods
Title
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
Title
Gastrointestinal symptoms (questionnaire)
Time Frame
on day 1, 7, 14 and 22 of the 21-day intervention periods
Title
Body weight
Time Frame
up to 21-day intervention periods
Title
Blood pressure
Time Frame
up to 21-day intervention periods
Title
Breath hydrogen
Time Frame
up to 21-day intervention periods
Title
Gut microbiota
Time Frame
Measured in a fresh feces sample from day 19-21 of the intervention periods

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Copenhagen, Department of Nutrition, Exercise and Sports
City
Copenhagen
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

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Effect of Potato Fiber on Appetite and Fecal Fat Excretion

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