Health TrialsbyHealthPanel

Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

ConditionBowel Function Dissatisfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorWageningen University

About this trial

A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

20 - 80 years old

Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6

Four or less bowel movements per week (low stool frequency) and/or

Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)

Disqualifiers

Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and subjects with medically diagnosed constipation (i.e., constipation related to anatomic, medication-related, or readily identifiable physiological causes.)

Less than one bowel movement per week during the screening

Antibiotic use within 3 months of the study screenings day

Chronic use of antacids and PPI's

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dried chicory root particles

    Dietary supplement

    The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (\~3mm).

  • Placebo

    Other intervention

    The control arm receives a placebo consisting of rice puff particles.

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Highest fiber doseExperimental treatment 1 intervention
Group B: Medium fiber doseExperimental treatment 1 intervention
Group C: Lowest fiber doseExperimental treatment 1 intervention
Group D: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bowel function (differences highest dose vs placebo) - bowel function satisfaction

Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely").

Time frame
Change after the intervention of 4 weeks
2

Bowel function (differences highest dose vs placebo) - ease of defecation

Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").

Time frame
Change after the intervention of 4 weeks
3

Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying

Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").

Time frame
Change after the intervention of 4 weeks
4

Bowel function (differences highest dose vs placebo) - stool consistency

Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).

Time frame
Change after the intervention of 4 weeks

Secondary outcomes

1

Fecal gut microbiota (between dose differences)

Measured in fecal samples using DNA sequencing. Compared between different fiber dosages and placebo.

Time frame
Change after the intervention of 4 weeks
2

Fecal gut microbiota activity (between dose differences)

Fecal gut microbiota activity is determined by measuring microbial metabolites in fecal samples among which fermentation products (short-chain fatty acids) using HPLC. Compared between different fiber dosages and placebo.

Time frame
Change after the intervention of 4 weeks
3

Quality of Life (between dose differences)

Quality of life is measured using the questionnaire Patient Assessment of Constipation - Quality of Life. Compared between different fiber dosages and placebo.

Time frame
Change after the intervention of 4 weeks
4

Constipation-related symptoms (between dose differences)

Constipation symptoms is measured using the questionnaire Patient Assessment of Constipation - Symptoms. Compared between different fiber dosages and placebo.

Time frame
Change after the intervention of 4 weeks

Other outcomes

1

Bowel function (weekly changes) - bowel function satisfaction

Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely"). Compared between different fiber dosages and placebo.

Time frame
Weekly development for a period of 4 weeks
2

Bowel function (weekly changes) - ease of defecation

Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").

Time frame
Weekly development for a period of 4 weeks
3

Bowel function (weekly changes) - feeling of incomplete bowel emptying

Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").

Time frame
Weekly development for a period of 4 weeks
4

Bowel function (weekly changes) - stool consistency

Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).

Time frame
Weekly development for a period of 4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wageningen University

Lead sponsor

WholeFiber BV

Collaborator

Wageningen University and Research, Laboratory of Microbiology

Collaborator

Wageningen University and Research, Division of Human Nutrition & Health

Collaborator

Wageningen University and Research

Collaborator

Source ClinicalTrials.gov
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