Clinical trial NCT02957318: Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Official title: Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Fat Increased
Obesity
Appetite
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Fecal fat excretion
timeFrame: Based on total feces collection the last 3 days of the 21-day intervention periods
measure: Subjective appetite sensations
timeFrame: Assessed on 3-hour meal test on last day of the 21-day intervention periods
Secondary outcomes:
measure: Ad libitum energy intake
timeFrame: Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods
measure: Fecal energy excretion
timeFrame: Measured based on total feces collection the last 3 days of the 21-day intervention periods
measure: Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)
timeFrame: Measured before and after the 21-day intervention periods
measure: Insulin and glucose
timeFrame: 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
measure: Gut permeability marker
timeFrame: Measured before and after the 21-day intervention periods
measure: Gastric emptying rate (w. paracetamol)
timeFrame: Measured every 30 minutes during the 3-hour meal test on last day of the 21-day intervention periods
measure: Gastrointestinal symptoms (questionnaire)
timeFrame: on day 1, 7, 14 and 22 of the 21-day intervention periods
measure: Body weight
timeFrame: up to 21-day intervention periods
measure: Blood pressure
timeFrame: up to 21-day intervention periods
measure: Breath hydrogen
timeFrame: up to 21-day intervention periods
measure: Gut microbiota
timeFrame: Measured in a fresh feces sample from day 19-21 of the intervention periods
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Nutrition, Exercise and Sports
Study officials:
References: