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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Fruit Products with the potential to improve constipation-related outcomes
King's College London
London, United Kingdom
RECRUITINGChange in faecal weight between baseline and week 4
Change in 7-day faecal weight
Time frame: week 4
Faecal microbiome diversity
Global microbiota composition (α-diversity, β-diversity)
Time frame: week 0 and 4
Faecal microbiome
Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).
Time frame: week 0 and 4
Faecal metabolomic profile
Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Time frame: week 0 and 4
Urine metabolomic profile
Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Time frame: week 0 and 4
Faecal short-chain fatty acids
Faecal short-chain fatty acids concentration (absolute and change)
Time frame: week 0 and 4
Faecal water content
Faecal water content (absolute and change) measured through lyophilisation
Time frame: week 0 and 4
Faecal pH
Faecal pH (absolute and change)
Time frame: week 0 and 4
Stool output
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Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..
Time frame: 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
Time frame: week 0 and 4
Gastrointestinal symptoms - PAC-SYM
The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).
Time frame: week 0 and 4
Gastrointestinal symptom severity questionnaire - CCCS
The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).
Time frame: week 0 and 4
Dietary intake
Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries
Time frame: 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".
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: week 0 and 4