Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

Sponsor

Wageningen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05473793

Collaborator

WholeFiber BV (Other)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Function Dissatisfaction	Dietary Supplement: Dried chicory root particles Other: Placebo	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: 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). Other Names: brand name: WholeFiber™
Experimental: 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.	Dietary Supplement: 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). Other Names: brand name: WholeFiber™
Experimental: 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.	Dietary Supplement: 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). Other Names: brand name: WholeFiber™
Placebo Comparator: 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).	Other: Placebo The control arm receives a placebo consisting of rice puff particles. Other Names: Rice puff particles

Outcome Measures

Primary Outcome Measures

Bowel function (differences highest dose vs placebo) - bowel function satisfaction [Change after the intervention of 4 weeks]
Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - ease of defecation [Change after the intervention of 4 weeks]
Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying [Change after the intervention of 4 weeks]
Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (differences highest dose vs placebo) - stool consistency [Change after the intervention of 4 weeks]
Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).
Bowel function (differences highest dose vs placebo) - stool frequency [Change after the intervention of 4 weeks]
Stool frequency is measured by counting number of bowel movements per week.

Secondary Outcome Measures

Fecal gut microbiota (between dose differences) [Change after the intervention of 4 weeks]
Measured in fecal samples using DNA sequencing. Compared between different fiber dosages and placebo.
Fecal gut microbiota activity (between dose differences) [Change after the intervention of 4 weeks]
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.
Quality of Life (between dose differences) [Change after the intervention of 4 weeks]
Quality of life is measured using the questionnaire Patient Assessment of Constipation - Quality of Life. Compared between different fiber dosages and placebo.
Constipation-related symptoms (between dose differences) [Change after the intervention of 4 weeks]
Constipation symptoms is measured using the questionnaire Patient Assessment of Constipation - Symptoms. Compared between different fiber dosages and placebo.
Bowel function (between dose differences) - bowel function satisfaction [Change after the intervention of 4 weeks]
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.
Bowel function (between dose differences) - ease of defecation [Change after the intervention of 4 weeks]
Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely"). Compared between different fiber dosages and placebo.
Bowel function (between dose differences) - feeling of incomplete bowel emptying [Change after the intervention of 4 weeks]
Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely"). Compared between different fiber dosages and placebo.
Bowel function (between dose differences) - stool consistency [Change after the intervention of 4 weeks]
Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea). Compared between different fiber dosages and placebo.
Bowel function (between dose differences) - stool frequency [Change after the intervention of 4 weeks]
Stool frequency is measured by counting number of bowel movements per week. Compared between different fiber dosages and placebo.

Other Outcome Measures

Bowel function (weekly changes) - bowel function satisfaction [Weekly development for a period of 4 weeks]
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.
Bowel function (weekly changes) - ease of defecation [Weekly development for a period of 4 weeks]
Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (weekly changes) - feeling of incomplete bowel emptying [Weekly development for a period of 4 weeks]
Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").
Bowel function (weekly changes) - stool consistency [Weekly development for a period of 4 weeks]
Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).
Bowel function (weekly changes) - stool frequency [Weekly development for a period of 4 weeks]
Stool frequency is measured by counting number of bowel movements per week.
Fecal gut microbiota (weekly changes) [Weekly development for a period of 4 weeks]
Measured in fecal samples using DNA sequencing.
Fecal gut microbiota activity (weekly changes) [Weekly development for a period of 4 weeks]
Fecal gut microbiota activity is determined by measuring microbial metabolites in fecal samples among which fermentation products (short-chain fatty acids) using HPLC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

20 - 80 years old
Unsatisfied with bowel functions (self-reported)
Four or less bowel movements per week
Hard or lumpy stools (Bristol stool form 1-2) during more than 25% of bowel movements
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., irritable bowel syndrome (IBS) or inflammatory bowel disease (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 1 month before the screening
Chronic use of blood glucose lowering medication
Consumption of supplements containing fibers, pro-/ post-/ synbiotics 1 month before the screening
Not willing to provide fecal 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 > 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 & 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