Clinical trial NCT05473793: Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
Official title: The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Function Dissatisfaction
Keywords: bowel function issues
constipation
gut microbiota
fiber intake
vegetable
intrinsic fiber
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: WholeFiber BV
name: Wageningen University and Research, Laboratory of Microbiology
name: Wageningen University and Research, Division of Human Nutrition & Health
name: Wageningen University and Research
First posted: 2022-07-26
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and one control (placebo) arm.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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;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

Primary outcomes:
measure: Bowel function (differences highest dose vs placebo) - bowel function satisfaction
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (differences highest dose vs placebo) - ease of defecation
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (differences highest dose vs placebo) - stool consistency
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (differences highest dose vs placebo) - stool frequency
timeFrame: Change after the intervention of 4 weeks
Secondary outcomes:
measure: Fecal gut microbiota (between dose differences)
timeFrame: Change after the intervention of 4 weeks
measure: Fecal gut microbiota activity (between dose differences)
timeFrame: Change after the intervention of 4 weeks
measure: Quality of Life (between dose differences)
timeFrame: Change after the intervention of 4 weeks
measure: Constipation-related symptoms (between dose differences)
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (between dose differences) - bowel function satisfaction
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (between dose differences) - ease of defecation
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (between dose differences) - feeling of incomplete bowel emptying
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (between dose differences) - stool consistency
timeFrame: Change after the intervention of 4 weeks
measure: Bowel function (between dose differences) - stool frequency
timeFrame: Change after the intervention of 4 weeks
Other outcomes:
measure: Bowel function (weekly changes) - bowel function satisfaction
timeFrame: Weekly development for a period of 4 weeks
measure: Bowel function (weekly changes) - ease of defecation
timeFrame: Weekly development for a period of 4 weeks
measure: Bowel function (weekly changes) - feeling of incomplete bowel emptying
timeFrame: Weekly development for a period of 4 weeks
measure: Bowel function (weekly changes) - stool consistency
timeFrame: Weekly development for a period of 4 weeks
measure: Bowel function (weekly changes) - stool frequency
timeFrame: Weekly development for a period of 4 weeks
measure: Fecal gut microbiota (weekly changes)
timeFrame: Weekly development for a period of 4 weeks
measure: Fecal gut microbiota activity (weekly changes)
timeFrame: Weekly development for a period of 4 weeks
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research, Division of Human Nutrition & Health
state: Gelderland
Study officials:
References:
citation: 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.
citation: 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.