Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

NCT05473793 | Recruiting

• 1 other identifier: NL80274.091.22
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Function Dissatisfaction

Keywords

bowel function issues; constipation; gut microbiota; fiber intake; vegetable; intrinsic fiber

Outcome Measures

Primary Outcomes (5)

• 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").

  Change after the intervention of 4 weeks

• 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").

  Change after the intervention of 4 weeks

• 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").

  Change after the intervention of 4 weeks

• 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).

  Change after the intervention of 4 weeks

• Bowel function (differences highest dose vs placebo) - stool frequency

  Stool frequency is measured by counting number of bowel movements per week.

  Change after the intervention of 4 weeks

Secondary Outcomes (9)

• Fecal gut microbiota (between dose differences)

  Change after the intervention of 4 weeks

• Fecal gut microbiota activity (between dose differences)

  Change after the intervention of 4 weeks

• Quality of Life (between dose differences)

  Change after the intervention of 4 weeks

• Constipation-related symptoms (between dose differences)

  Change after the intervention of 4 weeks

• Bowel function (between dose differences) - bowel function satisfaction

  Change after the intervention of 4 weeks

Other Outcomes (7)

• Bowel function (weekly changes) - bowel function satisfaction

  Weekly development for a period of 4 weeks

• Bowel function (weekly changes) - ease of defecation

  Weekly development for a period of 4 weeks

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

  Weekly development for a period of 4 weeks

Study Arms (4)

Highest fiber dose

EXPERIMENTAL

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

Medium fiber dose

EXPERIMENTAL

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

Lowest fiber dose

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

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).

Also known as: brand name: WholeFiber™

Highest fiber dose; Lowest fiber dose; Medium fiber dose

Placebo OTHER

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

Also known as: Rice puff particles

Control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• 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

Study Sites (1)

Wageningen University & Research, Division of Human Nutrition & Health

Wageningen, Gelderland, 6708 WE, Netherlands

RECRUITING

Related Publications (2)

• Puhlmann ML, de Vos WM. Back to the Roots: Revisiting the Use of the Fiber-Rich Cichorium intybusL. Taproots. Adv Nutr. 2020 Jul 1;11(4):878-889. doi: 10.1093/advances/nmaa025.

  PMID: 32199025 BACKGROUND

• Puhlmann ML, Jokela R, van Dongen KCW, Bui TPN, van Hangelbroek RWJ, Smidt H, de Vos WM, Feskens EJM. Dried chicory root improves bowel function, benefits intestinal microbial trophic chains and increases faecal and circulating short chain fatty acids in subjects at risk for type 2 diabetes. Gut Microbiome (Camb). 2022 Apr 28;3:e4. doi: 10.1017/gmb.2022.4. eCollection 2022.

  PMID: 39295776 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Edith JM Feskens, Prof. dr

CONTACT

+31317482567; edith.feskens@wur.nl

Sofie CC van der Zalm, MSc

CONTACT

+31618417162; vezel@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Edith Feskens

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

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 26, 2022
• Study Start: August 22, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)