Clinical trial NCT02838849: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dietary Habits
Bowel Dysfunction
Lead sponsor: Universidade de Passo Fundo
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: bowel habit: evacuation frequency
timeFrame: 14 days
measure: bowel habit: straining
timeFrame: 14 days
measure: bowel habit: stool consistency
timeFrame: 14 days
Secondary outcomes:
measure: Abdominal symptoms
timeFrame: 14 days
measure: Stool characteristics: fecal weight
timeFrame: 14 days
measure: Stool characteristics: percentage of water
timeFrame: 14 days
measure: Stool characteristics: pH
timeFrame: 14 days
measure: Intestinal microbiota
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Universidade de Passo Fundo
name: Fernando Fornari, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.