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Fiber and Water Improve Bowel Habit in Humans

Primary Purpose

Dietary Habits, Bowel Dysfunction

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fiber
Fiber and Water
Sponsored by
Universidade de Passo Fundo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dietary Habits

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • non-obese
  • absence of abdominal complaints

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Fiber

    Fiber and Water

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

    Abdominal symptoms
    self report of any abdominal symptom (yes/not) during treatment with fiber or fiber+water, including: pain, discomfort, distension, defecation urgency, backpain
    Stool characteristics: fecal weight
    A sample of feces was collected at the end of 14 days treatment and analyzed for fecal weight (g)
    Stool characteristics: percentage of water
    A sample of feces was collected at the end of 14 days treatment and analyzed for water percentage
    Stool characteristics: pH
    A sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH
    Intestinal microbiota
    A sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.

    Full Information

    First Posted
    July 11, 2016
    Last Updated
    July 16, 2016
    Sponsor
    Universidade de Passo Fundo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02838849
    Brief Title
    Fiber and Water Improve Bowel Habit in Humans
    Official Title
    Fiber and Water Improve Bowel Habit and Stool Microbiota in Healthy Participants: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade de Passo Fundo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Demographic and clinical data were collected and recorded in the first interview after signing the informed consent. The protocol was composed of two phases. The baseline phase lasted 7 days, when participants reported their usual diet on a food dairy in the first 3 days, between Sunday and Tuesday. Calculation of nutrient intake was performed using ADS nutri software (UFPEL, Pelotas, Brazil). Participants approved for the next phase were then randomized to fiber and fiber+water groups, which lasted 14 days. During this period participants were asked to report their intestinal habits including bowel movements, graduation of straining and subjective stool consistency. Participants were instructed to rank straining using a Likert scale from 1 (minimum) to 5 (maximum), and the Bristol scale for stool consistency. In the last day of treatment phase (Saturday) participants collected feces and urine of 24 hours, and responded a symptoms questionnaire. Food and liquid intake were recorded on a diary during the last 3 days of treatment for comparison with the baseline phase stage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dietary Habits, Bowel Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fiber
    Arm Type
    Sham Comparator
    Arm Description
    Participants were treated with 2 sachets of fiber orally a day for 14 days, after baseline characterization of bowel habit and stool features.
    Arm Title
    Fiber and Water
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fiber
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fiber and Water
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    bowel habit: evacuation frequency
    Description
    The patient reported in a diary the number of evacuations per day during 14 days of experimental use of fiber or fiber+water
    Time Frame
    14 days
    Title
    bowel habit: straining
    Description
    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
    Time Frame
    14 days
    Title
    bowel habit: stool consistency
    Description
    The patient reported the stool consistency of evacuations using a Bristol scale during 14 days of experimental use of fiber or fiber+water
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Abdominal symptoms
    Description
    self report of any abdominal symptom (yes/not) during treatment with fiber or fiber+water, including: pain, discomfort, distension, defecation urgency, backpain
    Time Frame
    14 days
    Title
    Stool characteristics: fecal weight
    Description
    A sample of feces was collected at the end of 14 days treatment and analyzed for fecal weight (g)
    Time Frame
    14 days
    Title
    Stool characteristics: percentage of water
    Description
    A sample of feces was collected at the end of 14 days treatment and analyzed for water percentage
    Time Frame
    14 days
    Title
    Stool characteristics: pH
    Description
    A sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH
    Time Frame
    14 days
    Title
    Intestinal microbiota
    Description
    A sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: non-obese absence of abdominal complaints Exclusion Criteria: use of medications that interfere with the gastrointestinal tract function past of abdominal surgery any acute or chronic disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Fornari, Professor
    Organizational Affiliation
    Universidade de Passo Fundo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35603590
    Citation
    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.
    Results Reference
    derived

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    Fiber and Water Improve Bowel Habit in Humans

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