Fiber and Water Improve Bowel Habit in Humans

Dietary Habits Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838849
• Other study ID #: MASTERUFRGSGROSA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 11, 2016
• Last updated: July 16, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Dysfunction
• Dietary Habits
• Intestinal Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade de Passo Fundo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Stool characteristics: pH	A sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH	14 days	No
Secondary	Intestinal microbiota	A sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.	14 days	No