Fiber and Water Improve Bowel Habit in Humans
- Conditions
- Dietary HabitsBowel Dysfunction
- Interventions
- Dietary Supplement: FiberDietary Supplement: Fiber and Water
- Registration Number
- NCT02838849
- Lead Sponsor
- Universidade de Passo Fundo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- non-obese
- absence of abdominal complaints
- use of medications that interfere with the gastrointestinal tract function
- past of abdominal surgery
- any acute or chronic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fiber Fiber Participants were treated with 2 sachets of fiber orally a day for 14 days, after baseline characterization of bowel habit and stool features. Fiber and Water 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.
- Primary Outcome Measures
Name Time Method bowel habit: straining 14 days 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 14 days The patient reported the stool consistency of evacuations using a Bristol scale during 14 days of experimental use of fiber or fiber+water
bowel habit: evacuation frequency 14 days The patient reported in a diary the number of evacuations per day during 14 days of experimental use of fiber or fiber+water
- Secondary Outcome Measures
Name Time Method Stool characteristics: fecal weight 14 days A sample of feces was collected at the end of 14 days treatment and analyzed for fecal weight (g)
Stool characteristics: percentage of water 14 days A sample of feces was collected at the end of 14 days treatment and analyzed for water percentage
Abdominal symptoms 14 days self report of any abdominal symptom (yes/not) during treatment with fiber or fiber+water, including: pain, discomfort, distension, defecation urgency, backpain
Stool characteristics: pH 14 days A sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH
Intestinal microbiota 14 days A sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.