A Phase 1/2 interventional study of Fiber and Fiber and Water in Dietary Habits and Bowel Dysfunction, sponsored by Universidade de Passo Fundo. Completed. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by Universidade de Passo Fundo · Phase 1/2, Interventional, and Treatment
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.
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Universidade de Passo Fundo is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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), keeping the usual liquid intake
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
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
Time frame: 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
Time frame: 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
Time frame: 14 days
Abdominal symptoms
self report of any abdominal symptom (yes/not) during treatment with fiber or fiber+water, including: pain, discomfort, distension, defecation urgency, backpain
Time frame: 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)
Time frame: 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
Time frame: 14 days
Stool characteristics: pH
A sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH
Time frame: 14 days
Intestinal microbiota
A sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.
Time frame: 14 days
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Universidade de Passo Fundo