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Completed

NCT Number: NCT02838849

Fiber and Water Improve Bowel Habit in Humans

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Bowel Dysfunction Digestive System Diseases Feeding Behavior Gastrointestinal Diseases Intestinal Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiber

Dietary Supplement

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

Dietary Supplement

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

Primary outcomes

  1. bowel habit: evacuation frequency

    Time frame: 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

  2. bowel habit: straining

    Time frame: 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

  3. bowel habit: stool consistency

    Time frame: 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

Secondary outcomes

  1. Abdominal symptoms

    Time frame: 14 days

    self report of any abdominal symptom (yes/not) during treatment with fiber or fiber+water, including: pain, discomfort, distension, defecation urgency, backpain

  2. Stool characteristics: fecal weight

    Time frame: 14 days

    A sample of feces was collected at the end of 14 days treatment and analyzed for fecal weight (g)

  3. Stool characteristics: percentage of water

    Time frame: 14 days

    A sample of feces was collected at the end of 14 days treatment and analyzed for water percentage

  4. Stool characteristics: pH

    Time frame: 14 days

    A sample of feces was collected at the end of 14 days treatment and analyzed for measurement of pH

  5. Intestinal microbiota

    Time frame: 14 days

    A sample of feces was collected at the end of 14 days treatment for PCR analyses of 10 bacteria groups.

Sponsors and collaborators

Lead sponsor

Universidade de Passo Fundo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 20, 2016
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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