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
About this trial
This is an interventional treatment trial for Dietary Habits
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
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
NCT ID
NCT02838849
First Posted
July 11, 2016
Last Updated
July 16, 2016
Sponsor
Universidade de Passo Fundo
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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