NCT02838849

Brief Summary

Twenty healthy volunteers had their baseline parameters (symptoms, bowel habit, quality of life, fecal characteristics and microbiota) measured during a week of monitoring followed by randomization to a 14 days course of increased fiber in diet or increased fiber and water intake, with repetition of parameters measuring at the end.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

July 11, 2016

Last Update Submit

July 16, 2016

Conditions

Dietary HabitsBowel Dysfunction

Outcome Measures

Primary Outcomes (3)

  • bowel habit: evacuation frequency

    The patient reported in a diary the number of evacuations per day during 14 days of experimental use of fiber or fiber+water

    14 days

  • bowel habit: straining

    The patient reported the effort for each evacuation using a Likert scale between 1 and 5 (1 = no effort / 5 = maximal) during 14 days of experimental use of fiber or fiber+water

    14 days

  • bowel habit: stool consistency

    The patient reported the stool consistency of evacuations using a Bristol scale during 14 days of experimental use of fiber or fiber+water

    14 days

Secondary Outcomes (5)

  • Abdominal symptoms

    14 days

  • Stool characteristics: fecal weight

    14 days

  • Stool characteristics: percentage of water

    14 days

  • Stool characteristics: pH

    14 days

  • Intestinal microbiota

    14 days

Study Arms (2)

Fiber

SHAM COMPARATOR

Participants were treated with 2 sachets of fiber orally a day for 14 days, after baseline characterization of bowel habit and stool features.

Dietary Supplement: Fiber

Fiber and Water

ACTIVE COMPARATOR

Participants were treated with 2 sachets of fiber orally a day and ingested 2 liters of water a day for 14 days, after baseline characterization of bowel habit and stool features.

Dietary Supplement: Fiber and Water

Interventions

FiberDIETARY_SUPPLEMENT

Fiber composed of wheat bran, pectin and green banana flour (total daily amount of 13 g for women and 20 g for men), keeping the usual liquid intake

Fiber
Fiber and WaterDIETARY_SUPPLEMENT

Fiber composed of wheat bran, pectin and green banana flour (total daily amount of 13 g for women and 20 g for men) plus 2 liter of water/day

Fiber and Water

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-obese
  • absence of abdominal complaints

You may not qualify if:

  • use of medications that interfere with the gastrointestinal tract function
  • past of abdominal surgery
  • any acute or chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Goncalves GVR, Canova R, Callegari-Jacques SM, Frandoloso R, Kreutz LC, Fornari F. Short-term intestinal effects of water intake in fibre supplementation in healthy, low-habitual fibre consumers: a phase 2 clinical trial. Int J Food Sci Nutr. 2022 Sep;73(6):841-849. doi: 10.1080/09637486.2022.2079117. Epub 2022 May 23.

    PMID: 35603590DERIVED

MeSH Terms

Conditions

Feeding BehaviorIntestinal Diseases

Interventions

Dietary FiberWater

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Fernando Fornari, Professor

    Universidade de Passo Fundo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 20, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share