Fiber and Water Improve Bowel Habit in Humans

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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Habits; Bowel Dysfunction
• Intervention / Treatment: Dietary supplement: Fiber; Dietary supplement: Fiber and Water

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Fiber; 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 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
Active Comparator: Fiber and Water; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade de Passo Fundo
• Investigators: Principal Investigator: Fernando Fornari, Professor, Universidade de Passo Fundo

Publications and helpful links

General Publications

• Gonçalves 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 16, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 16, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: MASTERUFRGSGROSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No