Physiological, Microbiological and Metabolomic Effects of Fruit Products

Not Applicable

• Conditions: Constipation - Functional
• Interventions: Other: Fruit Products

• Registration Number: NCT04086134
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Study Start: 2019-10-25
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-22
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention fruit products 2	Fruit Products	Three servings of fruit products per day for 4 weeks.
Intervention fruit products 1	Fruit Products	Three servings of fruit products per day for 4 weeks.
Control fruit products	Fruit Products	Three servings of control fruit products per day for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in faecal weight between baseline and week 4	week 4	Change in 7-day faecal weight

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom