NCT04086134

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

June 20, 2019

Last Update Submit

June 21, 2021

Conditions

Constipation - Functional

Keywords

constipation

Outcome Measures

Primary Outcomes (1)

  • Change in faecal weight between baseline and week 4

    Change in 7-day faecal weight

    week 4

Secondary Outcomes (16)

  • Faecal microbiome diversity

    week 0 and 4

  • Faecal microbiome

    week 0 and 4

  • Faecal metabolomic profile

    week 0 and 4

  • Urine metabolomic profile

    week 0 and 4

  • Faecal short-chain fatty acids

    week 0 and 4

  • +11 more secondary outcomes

Study Arms (3)

Intervention fruit products 1

EXPERIMENTAL

Three servings of fruit products per day for 4 weeks.

Other: Fruit Products

Intervention fruit products 2

EXPERIMENTAL

Three servings of fruit products per day for 4 weeks.

Other: Fruit Products

Control fruit products

PLACEBO COMPARATOR

Three servings of control fruit products per day for 4 weeks.

Other: Fruit Products

Interventions

Fruit ProductsOTHER

Fruit Products with the potential to improve constipation-related outcomes

Control fruit productsIntervention fruit products 1Intervention fruit products 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Whelan, MSc, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoi Katsirma, MSc

CONTACT

020 7848 4552zoi.katsirma@kcl.ac.uk

Eirini Dimidi, MSc, PhD

CONTACT

020 7848 4552eirini.dimidi@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

September 11, 2019

Study Start

October 25, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)