Physiological, Microbiological and Metabolomic Effects of Fruit Products

June 21, 2021 updated by: King's College London

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9NH
        • Recruiting
        • King's College London
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention fruit products 1
Three servings of fruit products per day for 4 weeks.
Other: Fruit Products
Fruit Products with the potential to improve constipation-related outcomes
EXPERIMENTAL: Intervention fruit products 2
Three servings of fruit products per day for 4 weeks.
Other: Fruit Products
Fruit Products with the potential to improve constipation-related outcomes
PLACEBO_COMPARATOR: Control fruit products
Three servings of control fruit products per day for 4 weeks.
Other: Fruit Products
Fruit Products with the potential to improve constipation-related outcomes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in faecal weight between baseline and week 4
Time Frame: week 4
Change in 7-day faecal weight
week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Faecal microbiome diversity
Time Frame: week 0 and 4
Global microbiota composition (α-diversity, β-diversity)
week 0 and 4
Faecal microbiome
Time Frame: week 0 and 4
Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).
week 0 and 4
Faecal metabolomic profile
Time Frame: week 0 and 4
Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
week 0 and 4
Urine metabolomic profile
Time Frame: week 0 and 4
Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
week 0 and 4
Faecal short-chain fatty acids
Time Frame: week 0 and 4
Faecal short-chain fatty acids concentration (absolute and change)
week 0 and 4
Faecal water content
Time Frame: week 0 and 4
Faecal water content (absolute and change) measured through lyophilisation
week 0 and 4
Faecal pH
Time Frame: week 0 and 4
Faecal pH (absolute and change)
week 0 and 4
Stool output
Time Frame: week 0 and 4
Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..
week 0 and 4
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
week 0 and 4
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).
week 0 and 4
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).
week 0 and 4
Dietary intake
Time Frame: week 0 and 4
Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries
week 0 and 4
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".
week 0 and 4
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)
week 0 and 4
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
week 0 and 4
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.
week 0 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Imperial College London
Queen Mary University of London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Whelan, MSc, PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR-17/18-7858

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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