Back to resultsPhysiological, Microbiological and Metabolomic Effects of Fruit Products
Primary Purpose
Constipation - Functional
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fruit Products
Sponsored by
About this trial
This is an interventional treatment trial for Constipation - Functional focused on measuring constipation
Eligibility Criteria
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.
Sites / Locations
- King's College LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Intervention fruit products 1
Intervention fruit products 2
Control fruit products
Arm Description
Three servings of fruit products per day for 4 weeks.
Three servings of fruit products per day for 4 weeks.
Three servings of control fruit products per day for 4 weeks.
Outcomes
Primary Outcome Measures
Change in faecal weight between baseline and week 4
Change in 7-day faecal weight
Secondary Outcome Measures
Faecal microbiome diversity
Global microbiota composition (α-diversity, β-diversity)
Faecal microbiome
Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).
Faecal metabolomic profile
Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Urine metabolomic profile
Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Faecal short-chain fatty acids
Faecal short-chain fatty acids concentration (absolute and change)
Faecal water content
Faecal water content (absolute and change) measured through lyophilisation
Faecal pH
Faecal pH (absolute and change)
Stool output
Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..
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
Gastrointestinal symptoms - PAC-SYM
The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).
Gastrointestinal symptom severity questionnaire - CCCS
The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).
Dietary intake
Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries
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".
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)
Acceptability of interventions
Acceptability of the interventions measured using a questionnaire that included 3- and 4-point likert scales and open-text answers
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.
Full Information
NCT ID
NCT04086134
First Posted
June 20, 2019
Last Updated
June 21, 2021
Sponsor
King's College London
Collaborators
Queen Mary University of London, Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT04086134
Brief Title
Physiological, Microbiological and Metabolomic Effects of Fruit Products
Official Title
The FruGut Study: Physiological, Microbiological and Metabolomic Effects of Fruit Products
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Queen Mary University of London, Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional
Keywords
constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention fruit products 1
Arm Type
Experimental
Arm Description
Three servings of fruit products per day for 4 weeks.
Arm Title
Intervention fruit products 2
Arm Type
Experimental
Arm Description
Three servings of fruit products per day for 4 weeks.
Arm Title
Control fruit products
Arm Type
Placebo Comparator
Arm Description
Three servings of control fruit products per day for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Fruit Products
Intervention Description
Fruit Products with the potential to improve constipation-related outcomes
Primary Outcome Measure Information:
Title
Change in faecal weight between baseline and week 4
Description
Change in 7-day faecal weight
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Faecal microbiome diversity
Description
Global microbiota composition (α-diversity, β-diversity)
Time Frame
week 0 and 4
Title
Faecal microbiome
Description
Ιndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).
Time Frame
week 0 and 4
Title
Faecal metabolomic profile
Description
Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Time Frame
week 0 and 4
Title
Urine metabolomic profile
Description
Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance
Time Frame
week 0 and 4
Title
Faecal short-chain fatty acids
Description
Faecal short-chain fatty acids concentration (absolute and change)
Time Frame
week 0 and 4
Title
Faecal water content
Description
Faecal water content (absolute and change) measured through lyophilisation
Time Frame
week 0 and 4
Title
Faecal pH
Description
Faecal pH (absolute and change)
Time Frame
week 0 and 4
Title
Stool output
Description
Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..
Time Frame
week 0 and 4
Title
Individual gastrointestinal symptoms
Description
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
Title
Gastrointestinal symptoms - PAC-SYM
Description
The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).
Time Frame
week 0 and 4
Title
Gastrointestinal symptom severity questionnaire - CCCS
Description
The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).
Time Frame
week 0 and 4
Title
Dietary intake
Description
Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries
Time Frame
week 0 and 4
Title
Constipation-related quality of life
Description
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
Title
Whole and regional gut transit time/pH
Description
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
Title
Acceptability of interventions
Description
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
Title
Compliance
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoi Katsirma, MSc
Phone
020 7848 4552
Email
zoi.katsirma@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Eirini Dimidi, MSc, PhD
Phone
020 7848 4552
Email
eirini.dimidi@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Whelan, MSc, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoi Katsirma
Phone
02078484552
Email
frugut@kcl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physiological, Microbiological and Metabolomic Effects of Fruit Products
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