Physiological, Microbiological and Metabolomic Effects of Fruit Products

Study Overview
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Brief Summary
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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.

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

Conditions
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Constipation - Functional

Intervention / Treatment
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* Other: Fruit Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18-65 years. 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). Individuals who are willing to consume fruit products for 4 weeks. Individuals who consume <30g of fibre per day Individuals with a BMI of 18.5-29.99 kg/m2. Individuals able to give informed consent. Exclusion Criteria: Females who report to be pregnant or lactating. Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week). Allergy, intolerance or dislike of the fruit products used in this intervention. Sulphite allergy or sensitivity. Ongoing alcohol, drug or medication abuse. 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. Medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them. Frequent use of rescue laxatives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention fruit products 1<br>Three servings of fruit products per day for 4 weeks. | Other: Fruit Products<br>* Fruit Products with the potential to improve constipation-related outcomes<br>|
| Experimental: Intervention fruit products 2<br>Three servings of fruit products per day for 4 weeks. | Other: Fruit Products<br>* Fruit Products with the potential to improve constipation-related outcomes<br>|
| Placebo Comparator: Control fruit products<br>Three servings of control fruit products per day for 4 weeks. | Other: Fruit Products<br>* Fruit Products with the potential to improve constipation-related outcomes<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation