Bowel Function DissatisfactionHappYFiberNCT05473793
Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
A study testing Dried chicory root particles in people with Bowel Function Dissatisfaction, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Function Dissatisfaction
- What is being tested?
- Dried chicory root particles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Aug 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 \& 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University & Research, Division of Human Nutrition & Health
Wageningen, Gelderland, 6708 WE
Sofie CC van der Zalm, MSc, +31 6 18 41 71 62, sofie.vanderzalm@wur.nl
Marie-Luise Puhlmann, MSc, +31 6 38 03 11 29, marie-luise.puhlmann@wur.nl
About this study
Official title: The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues
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.
Read the 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.
- Conditions
- Bowel Function Dissatisfaction
- Being tested
- Dried chicory root particles, Placebo
- Keywords
- bowel function issues, constipation, gut microbiota, fiber intake, vegetable, intrinsic fiber
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried chicory root particlesDietary supplement
Also called brand name: WholeFiber™
The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (~3mm).
PlaceboOther
Also called Rice puff particles
The control arm receives a placebo consisting of rice puff particles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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").
Measured: 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").
Measured: 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).
Measured: 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.
Measured: Change after the intervention of 4 weeks
Secondary outcomes (9)
Fecal gut microbiota (between dose differences)
Measured in fecal samples using DNA sequencing. Compared between different fiber dosages and placebo.
Measured: Change after the intervention of 4 weeks
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.
Measured: Change after the intervention of 4 weeks
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.
Measured: Change after the intervention of 4 weeks
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.
Measured: Change after the intervention of 4 weeks
Bowel function (between dose differences) - 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.
Measured: Change after the intervention of 4 weeks
Bowel function (between dose differences) - ease of defecation
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.
Measured: Change after the intervention of 4 weeks
Bowel function (between dose differences) - 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"). Compared between different fiber dosages and placebo.
Measured: Change after the intervention of 4 weeks
Bowel function (between dose differences) - stool consistency
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.
Measured: Change after the intervention of 4 weeks
Bowel function (between dose differences) - stool frequency
Stool frequency is measured by counting number of bowel movements per week. Compared between different fiber dosages and placebo.
Measured: Change after the intervention of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start22 Aug 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bowel Function DissatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and one control (placebo) arm.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- WholeFiber BV, Wageningen University and Research, Laboratory of Microbiology, Wageningen University and Research, Division of Human Nutrition & Health, Wageningen University and Research
- Responsible party
- Principal investigator, Edith Feskens, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473793
- Sponsor's protocol ID
- NL80274.091.22
- Acronym
- HappYFiber
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the data contains sensitive personal information researchers interested in the data can contact the principal investigator.
Publications
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.
PubMed 32199025Puhlmann 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.
PubMed 39295776
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues
- ClinicalTrials.gov ID
- NCT05473793
- Acronym / sponsor ID
- HappYFiber / NL80274.091.22
- Conditions
- Bowel Function Dissatisfaction
- Keywords
- bowel function issues, constipation, gut microbiota, fiber intake, vegetable, intrinsic fiber
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- WholeFiber BV, Wageningen University and Research, Laboratory of Microbiology, Wageningen University and Research, Division of Human Nutrition & Health, Wageningen University and Research
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and one control (placebo) arm.
| Arm | Type | Receives |
|---|---|---|
| Highest fiber dose | Experimental | Dietary Supplement: Dried chicory root particlesThis 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. |
| Medium fiber dose | Experimental | Dietary Supplement: Dried chicory root particlesThis 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. |
| Lowest fiber dose | Experimental | Dietary Supplement: Dried chicory root particlesThis 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. |
| Control | Placebo comparator | Other: PlaceboThis 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). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
- Consumption of supplements containing fibres (other than laxatives), pro-/ post-/ synbiotics 1 month before the screening
- Not willing to provide faecal samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried chicory root particlesAlso: brand name: WholeFiber™The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (~3mm). | Dietary supplement | Highest fiber dose, Lowest fiber dose, Medium fiber dose |
| PlaceboAlso: Rice puff particlesThe control arm receives a placebo consisting of rice puff particles. | Other | Control |
Primary outcome
Bowel function (differences highest dose vs placebo) - bowel function satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change after the intervention of 4 weeks
Stool frequency is measured by counting number of bowel movements per week.
9 secondary outcomes
Fecal gut microbiota (between dose differences)
Time frame: Change after the intervention of 4 weeks
Fecal gut microbiota activity (between dose differences)
Time frame: Change after the intervention of 4 weeks
Quality of Life (between dose differences)
Time frame: Change after the intervention of 4 weeks
Constipation-related symptoms (between dose differences)
Time frame: Change after the intervention of 4 weeks
Bowel function (between dose differences) - bowel function satisfaction
Time frame: Change after the intervention of 4 weeks
Bowel function (between dose differences) - ease of defecation
Time frame: Change after the intervention of 4 weeks
Bowel function (between dose differences) - feeling of incomplete bowel emptying
Time frame: Change after the intervention of 4 weeks
Bowel function (between dose differences) - stool consistency
Time frame: Change after the intervention of 4 weeks
Bowel function (between dose differences) - stool frequency
Time frame: Change after the intervention of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 32199025Puhlmann 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.
- Background: PubMed 39295776Puhlmann 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.
- Individual participant dataSharing planned: No. As the data contains sensitive personal information researchers interested in the data can contact the principal investigator.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried chicory root particles in people with Bowel Function Dissatisfaction, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edith JM Feskens, Prof. dr (+31317482567, edith.feskens@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function (differences highest dose vs placebo) - bowel function satisfaction (time frame: Change after the intervention of 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.