Suspended
The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
What is being tested
Fruit Products
Other
Who is being recruted
Constipation+1
+ Signs and Symptoms
+ Signs and Symptoms, Digestive
From 18 to 65 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-Controlled
Interventional
Study Start: October 2019
Summary
Principal SponsorKing's College London
Study ContactZoi Katsirma, MScMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: October 25, 2019
Actual date on which the first participant was enrolled.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 TitleThe FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
Principal SponsorKing's College London
Study ContactZoi Katsirma, MScMore contacts
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ConstipationSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms
Criteria
6 inclusion criteria required to participate
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
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8 exclusion criteria prevent from participating
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboThree servings of control fruit products per day for 4 weeks.
Group II
ExperimentalThree servings of fruit products per day for 4 weeks.
Group III
ExperimentalThree servings of fruit products per day for 4 weeks.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center