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Completed

NCT Number: NCT02957318

Effect of Potato Fiber on Appetite and Fecal Fat Excretion

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.

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Key information

Conditions

Fecal Fat Increased Appetite Body Weight Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Steatorrhea

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FiberBind

Dietary 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 fiber

Dietary Supplement

Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.

Placebo

Dietary Supplement

Low-fiber control

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Acronym: POFIBA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2016
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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