Physiological, Microbiological and Metabolomic Effects of Fruit Products

The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products

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.

Study Overview

• Status: Recruiting
• Conditions: Constipation - Functional
• Intervention / Treatment: Other: Fruit Products

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoi Katsirma, MSc; Phone Number: 020 7848 4552; Email: zoi.katsirma@kcl.ac.uk
• Study Contact Backup: Name: Eirini Dimidi, MSc, PhD; Phone Number: 020 7848 4552; Email: eirini.dimidi@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • Recruiting
    • King's College London
    • Contact: Zoi Katsirma; Phone Number: 02078484552; Email: frugut@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention fruit products 1; Three servings of fruit products per day for 4 weeks.	Other: Fruit Products; Fruit Products with the potential to improve constipation-related outcomes
EXPERIMENTAL: Intervention fruit products 2; Three servings of fruit products per day for 4 weeks.	Other: Fruit Products; Fruit Products with the potential to improve constipation-related outcomes
PLACEBO_COMPARATOR: Control fruit products; Three servings of control fruit products per day for 4 weeks.	Other: Fruit Products; Fruit Products with the potential to improve constipation-related outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in faecal weight between baseline and week 4	Change in 7-day faecal weight	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal microbiome diversity	Global microbiota composition (α-diversity, β-diversity)	week 0 and 4
Faecal microbiome	Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).	week 0 and 4
Faecal metabolomic profile	Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance	week 0 and 4
Urine metabolomic profile	Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance	week 0 and 4
Faecal short-chain fatty acids	Faecal short-chain fatty acids concentration (absolute and change)	week 0 and 4
Faecal water content	Faecal water content (absolute and change) measured through lyophilisation	week 0 and 4
Faecal pH	Faecal pH (absolute and change)	week 0 and 4
Stool output	Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..	week 0 and 4
Individual gastrointestinal symptoms	The 7-day diaries contain a short questionnaire for each bowel movement to monitor completeness, spontaneity, straining and need for manual maneuvers. The validated Gastrointestinal Symptom Rating Scale will be used over a 7-day period	week 0 and 4
Gastrointestinal symptoms - PAC-SYM	The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).	week 0 and 4
Gastrointestinal symptom severity questionnaire - CCCS	The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).	week 0 and 4
Dietary intake	Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries	week 0 and 4
Constipation-related quality of life	Constipation-related quality of life (absolute and change) which will be measured with the condition-specific validated Patient Assessment of Constipation Quality of Life (PAC-Qol) questionnaire. PAC-QoL is a self-report 28-item tool that uses a 5-point Likert scale ranging from "Not at all" to "Extremely".	week 0 and 4
Whole and regional gut transit time/pH	Whole gut transit time and regional gut pH (absolute and change) will be assessed in a subset of participants (n=39), by using a motility capsule (SmartPill ®, Medtronic)	week 0 and 4
Acceptability of interventions	Acceptability of the interventions measured using a questionnaire that included 3- and 4-point likert scales and open-text answers	week 0 and 4
Compliance	Compliance to the study interventions will be measured using specific questions relevant to the intervention received in the food and drink diary completed at week 4, by regular phone calls with participants throughout the intervention period, and by the number of unconsumed fruit products returned by the participants after the end of the intervention.	week 0 and 4

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Imperial College London; Queen Mary University of London
• Investigators: Principal Investigator: Kevin Whelan, MSc, PhD, King's College London

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2019
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: HR-17/18-7858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No