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Fiber and Water Improve Bowel Habit in Humans

Fiber and Water Improve Bowel Habit and Stool Microbiota in Healthy Participants: a Randomized Clinical Trial

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838849
Enrollment
20
Registered
2016-07-20
Start date
2015-08-31
Completion date
2016-07-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits, Bowel Dysfunction

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.

Interventions

DIETARY_SUPPLEMENTFiber

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

DIETARY_SUPPLEMENTFiber and Water

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

Sponsors

Universidade de Passo Fundo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
bowel habit: evacuation frequency14 daysThe patient reported in a diary the number of evacuations per day during 14 days of experimental use of fiber or fiber+water
bowel habit: straining14 daysThe 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 consistency14 daysThe patient reported the stool consistency of evacuations using a Bristol scale during 14 days of experimental use of fiber or fiber+water

Secondary

MeasureTime frameDescription
Stool characteristics: pH14 daysA sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH
Abdominal symptoms14 daysself report of any abdominal symptom (yes/not) during treatment with fiber or fiber+water, including: pain, discomfort, distension, defecation urgency, backpain
Intestinal microbiota14 daysA sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.
Stool characteristics: fecal weight14 daysA sample of feces was collected at the end of 14 days treatment and analyzed for fecal weight (g)
Stool characteristics: percentage of water14 daysA sample of feces was collected at the end of 14 days treatment and analyzed for water percentage

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026