Physiological, Microbiological and Metabolomic Effects of Fruit Products

Overview

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.

Full Title of Study: “The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 31, 2021

Interventions

  • Other: Fruit Products
    • Fruit Products with the potential to improve constipation-related outcomes

Arms, Groups and Cohorts

  • Experimental: Intervention fruit products 1
    • Three servings of fruit products per day for 4 weeks.
  • Experimental: Intervention fruit products 2
    • Three servings of fruit products per day for 4 weeks.
  • Placebo Comparator: Control fruit products
    • Three servings of control fruit products per day for 4 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change in faecal weight between baseline and week 4
    • Time Frame: week 4
    • Change in 7-day faecal weight

Secondary Measures

  • Faecal microbiome diversity
    • Time Frame: week 0 and 4
    • Global microbiota composition (α-diversity, β-diversity)
  • Faecal microbiome
    • Time Frame: week 0 and 4
    • Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).
  • Faecal metabolomic profile
    • Time Frame: week 0 and 4
    • Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
  • Urine metabolomic profile
    • Time Frame: week 0 and 4
    • Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
  • Faecal short-chain fatty acids
    • Time Frame: week 0 and 4
    • Faecal short-chain fatty acids concentration (absolute and change)
  • Faecal water content
    • Time Frame: week 0 and 4
    • Faecal water content (absolute and change) measured through lyophilisation
  • Faecal pH
    • Time Frame: week 0 and 4
    • Faecal pH (absolute and change)
  • Stool output
    • Time Frame: week 0 and 4
    • Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..
  • Individual gastrointestinal symptoms
    • Time Frame: week 0 and 4
    • 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
  • Gastrointestinal symptoms – PAC-SYM
    • Time Frame: week 0 and 4
    • The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).
  • Gastrointestinal symptom severity questionnaire – CCCS
    • Time Frame: week 0 and 4
    • The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).
  • Dietary intake
    • Time Frame: week 0 and 4
    • Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries
  • Constipation-related quality of life
    • Time Frame: week 0 and 4
    • 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”.
  • Whole and regional gut transit time/pH
    • Time Frame: week 0 and 4
    • 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)
  • Acceptability of interventions
    • Time Frame: week 0 and 4
    • Acceptability of the interventions measured using a questionnaire that included 3- and 4-point likert scales and open-text answers
  • Compliance
    • Time Frame: week 0 and 4
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • King’s College London
  • Collaborator
    • Queen Mary University of London
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kevin Whelan, MSc, PhD, Principal Investigator, King’s College London
  • Overall Contact(s)
    • Zoi Katsirma, MSc, 020 7848 4552, zoi.katsirma@kcl.ac.uk

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