Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957318
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Anne Birgitte Raben, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Fecal Fat Increased Obesity Appetite Dietary Supplement: FiberBind Dietary Supplement: RG-I fiber Dietary Supplement: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FiberBind Dietary Supplement: 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 Dietary Supplement: RG-I fiber
Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.

Placebo Comparator: Placebo Dietary Supplement: Placebo
Low-fiber control




Primary Outcome Measures :
  1. Fecal fat excretion [ Time Frame: Based on total feces collection the last 3 days of the 21-day intervention periods ]
  2. 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)


Secondary Outcome Measures :
  1. Ad libitum energy intake [ Time Frame: Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods ]
  2. Fecal energy excretion [ Time Frame: Measured based on total feces collection the last 3 days of the 21-day intervention periods ]
  3. Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) [ Time Frame: Measured before and after the 21-day intervention periods ]
  4. 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 ]
  5. Gut permeability marker [ Time Frame: Measured before and after the 21-day intervention periods ]
  6. 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 ]
  7. Gastrointestinal symptoms (questionnaire) [ Time Frame: on day 1, 7, 14 and 22 of the 21-day intervention periods ]
  8. Body weight [ Time Frame: up to 21-day intervention periods ]
  9. Blood pressure [ Time Frame: up to 21-day intervention periods ]
  10. Breath hydrogen [ Time Frame: up to 21-day intervention periods ]
  11. Gut microbiota [ Time Frame: Measured in a fresh feces sample from day 19-21 of the intervention periods ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957318


Locations
Layout table for location information
Denmark
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Layout table for additonal information
Responsible Party: Anne Birgitte Raben, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02957318    
Other Study ID Numbers: B 326
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Steatorrhea
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases