Clinical trial NCT04086134: Physiological, Microbiological and Metabolomic Effects of Fruit Products
Official title: The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation - Functional
Keywords: constipation
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
name: Imperial College London
First posted: 2019-09-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18-65 years.
2. Individuals meeting the Rome IV criteria for functional constipation, in addition to having \<7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as Type 1 \& 2 of the Bristol Stool Form Scale).
3. Individuals who are willing to consume fruit products for 4 weeks.
4. Individuals who consume \<30g of fibre per day
5. Individuals with a BMI of 18.5-29.99 kg/m2.
6. Individuals able to give informed consent.

Exclusion Criteria:

1. Females who report to be pregnant or lactating.
2. Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week).
3. Allergy, intolerance or dislike of the fruit products used in this intervention.
4. Sulphite allergy or sensitivity.
5. Ongoing alcohol, drug or medication abuse.
6. Major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy, appendicectomy and haemorrhoidectomy.
7. Medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them.
8. Frequent use of rescue laxatives.

Primary outcomes:
measure: Change in faecal weight between baseline and week 4
timeFrame: week 4
Secondary outcomes:
measure: Faecal microbiome diversity
timeFrame: week 0 and 4
measure: Faecal microbiome
timeFrame: week 0 and 4
measure: Faecal metabolomic profile
timeFrame: week 0 and 4
measure: Urine metabolomic profile
timeFrame: week 0 and 4
measure: Faecal short-chain fatty acids
timeFrame: week 0 and 4
measure: Faecal water content
timeFrame: week 0 and 4
measure: Faecal pH
timeFrame: week 0 and 4
measure: Stool output
timeFrame: week 0 and 4
measure: Individual gastrointestinal symptoms
timeFrame: week 0 and 4
measure: Gastrointestinal symptoms - PAC-SYM
timeFrame: week 0 and 4
measure: Gastrointestinal symptom severity questionnaire - CCCS
timeFrame: week 0 and 4
measure: Dietary intake
timeFrame: week 0 and 4
measure: Constipation-related quality of life
timeFrame: week 0 and 4
measure: Whole and regional gut transit time/pH
timeFrame: week 0 and 4
measure: Acceptability of interventions
timeFrame: week 0 and 4
measure: Compliance
timeFrame: week 0 and 4
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Kevin Whelan, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: