Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Background: Bowel function issues can have a substantial effect on quality of life. Additional fiber intake might modulate bowel function and gut microbiota, thereby increasing stool frequency and consistency. This could improve defecation ease, feeling of incomplete bowel emptying and bowel function satisfaction. We hypothesize that a dried vegetable, that is naturally high in fiber within plant cells could improve bowel function in subjects with bowel function issues.

Objective: The main objective of the study is to assess whether a dried multifiber vegetable improves bowel function assessed by stool frequency, consistency, defecation ease, feeling of incomplete bowel emptying and satisfaction. Secondary objectives are to assess whether these effects are dose-dependent and associated with the modulation of the gut microbiota and activity. Furthermore, the adaption of bowel function and adaptation of the gut microbiota and activity over time will be analyzed.

Study design: A parallel, randomized, double-blind, placebo-controlled trial of four weeks with one placebo control and three intervention arms that differ in intervention product dose.

Study population: Healthy human volunteers, 20 - 80y old, with bowel function issues reflected in low stool frequency/consistency, difficulty to defecate, and dissatisfaction with their current bowel function.

Intervention: A vegetable product consisting of dried chicory root cubes containing 85% dietary fiber is added to the daily diet. The intervention product is consumed twice daily for four weeks with a maximum dose of 15 g/day. The control (placebo) consists of easily digestible rice puff particles and is consumed in the same manner as the intervention.

Main study parameters/endpoints: Main study outcome are endpoint (week 4) differences from baseline between the highest dose (15 g/day) of the treatment intervention and placebo in bowel function assessed by changes in stool frequency, stool consistency, ease of defecation, incomplete feeling of bowel emptying and bowel function satisfaction. Secondary endpoints are gut microbiota composition and differences in bowel function, quality of life and constipation symptoms assessment between all doses and placebo. Finally, changes over time in gut microbiota and bowel function will be assessed.

Conditions

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Bowel Function Dissatisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and one control (placebo) arm.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Subjects not receiving the intervention product will consume a placebo (rice puff particles). Neither the investigator, nor the participants, nor the outcome assessor will know who received what. No Care Provider is included in this trial.

Study Groups

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Highest fiber dose

This arm receives the highest dose of the intervention product, which is 15g dried vegetable per day divided into two portions of each 7.5g, which are consumed during the course of the day in the food of choice.

Group Type EXPERIMENTAL

Dried chicory root particles

Intervention Type DIETARY_SUPPLEMENT

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

Medium fiber dose

This arm receives the highest dose of the intervention product, which is 10g dried vegetable per day divided into two portions of each 5.0g, which are consumed during the course of the day in the food of choice.

Group Type EXPERIMENTAL

Dried chicory root particles

Intervention Type DIETARY_SUPPLEMENT

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

Lowest fiber dose

This arm receives the highest dose of the intervention product, which is 5g dried vegetable per day divided into two portions of each 2.5g, which are consumed during the course of the day in the food of choice.

Group Type EXPERIMENTAL

Dried chicory root particles

Intervention Type DIETARY_SUPPLEMENT

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

Control

This arm is the control arm receiving as placebo rice puff particles each day, whose amount corresponds iso-calorically to the medium fiber dosage (\~ 21 kcal/day).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Dried chicory root particles

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Other Intervention Names

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brand name: WholeFiber™ Rice puff particles

Eligibility Criteria

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Inclusion Criteria

* 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)
* Able to read and understand Dutch or English

Exclusion Criteria

* 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
* Medical drug use:

* Antibiotic use within 3 months of the study screenings day
* Chronic use of antacids and PPI's
* Use of laxatives during the screening
* Chronic use of blood glucose lowering medication
* Consumption of supplements containing fibres (other than laxatives), pro-/ post-/ synbiotics 1 month before the screening
* Not willing to provide faecal samples
* Unable to comply with proper study procedures
* For women of childbearing age: current or planned pregnancy, lactation
* Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.)
* Reported unexplained weight loss or weight gain of greater than 5 kg in the month prior to pre-study screening
* Reported slimming or medically prescribed diet
* Reported macrobiotic lifestyle
* Personnel the Division of Human Nutrition \&amp; Health or the Laboratory of Microbiology
* Current participation in other medical scientific research
* Not having a general practitioner
* Not willing to be informed about accidental discoveries in relation to the subjects health

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes