Effect of Potato Fiber on Appetite and Fecal Fat Excretion

Obesity Clinical Trial

— POFIBA  

Official title:

Effect of Potato Fiber on Appetite and Fecal Fat Excretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957318
• Other study ID #: B 326
• Status: Completed
• Phase: N/A
• First received: November 1, 2016
• Last updated: September 12, 2017
• Start date: September 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite
• Fecal Fat Increased
• Obesity
• Steatorrhea

Intervention

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

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Nutrition, Exercise and Sports	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal fat excretion		Based on total feces collection the last 3 days of the 21-day intervention periods
Primary	Subjective appetite sensations	Assessed by visual analogue scales (VAS)	Assessed on 3-hour meal test on last day of the 21-day intervention periods
Secondary	Ad libitum energy intake		Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods
Secondary	Fecal energy excretion		Measured based on total feces collection the last 3 days of the 21-day intervention periods
Secondary	Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)		Measured before and after the 21-day intervention periods
Secondary	Insulin and glucose		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
Secondary	Gut permeability marker		Measured before and after the 21-day intervention periods
Secondary	Gastric emptying rate (w. paracetamol)		Measured every 30 minutes during the 3-hour meal test on last day of the 21-day intervention periods
Secondary	Gastrointestinal symptoms (questionnaire)		on day 1, 7, 14 and 22 of the 21-day intervention periods
Secondary	Body weight		up to 21-day intervention periods
Secondary	Blood pressure		up to 21-day intervention periods
Secondary	Breath hydrogen		up to 21-day intervention periods
Secondary	Gut microbiota		Measured in a fresh feces sample from day 19-21 of the intervention periods