NCT02957318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

September 13, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

November 1, 2016

Last Update Submit

September 12, 2017

Conditions

Fecal Fat IncreasedObesityAppetite

Outcome Measures

Primary Outcomes (2)

  • Fecal fat excretion

    Based on total feces collection the last 3 days of the 21-day intervention periods

  • 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 Outcomes (11)

  • Ad libitum energy intake

    Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods

  • Fecal energy excretion

    Measured based on total feces collection the last 3 days of the 21-day intervention periods

  • Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)

    Measured before and after the 21-day intervention periods

  • 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

  • Gut permeability marker

    Measured before and after the 21-day intervention periods

  • +6 more secondary outcomes

Study Arms (3)

FiberBind

EXPERIMENTAL
Dietary Supplement: FiberBind

RG-I fiber

EXPERIMENTAL
Dietary Supplement: RG-I fiber

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

FiberBindDIETARY_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).

FiberBind
RG-I fiberDIETARY_SUPPLEMENT

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

RG-I fiber
PlaceboDIETARY_SUPPLEMENT

Low-fiber control

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Men
  • BMI between 18.5 and 27.0 kg/m2
  • Age 20-40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 1958, Denmark

Location

MeSH Terms

Conditions

SteatorrheaObesity

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 7, 2016

Study Start

September 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

September 13, 2017

Record last verified: 2017-05

Locations

DK(1)