Physiological, Microbiological and Metabolomic Effects of Fruit Products

Constipation - Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04086134
• Other study ID #: HR-17/18-7858
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: King's College London
• Contact: Zoi Katsirma, MSc
• Phone: 020 7848 4552
• Email: zoi.katsirma[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Other:
• Fruit Products
Fruit Products with the potential to improve constipation-related outcomes

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Imperial College London, Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in faecal weight between baseline and week 4	Change in 7-day faecal weight	week 4
Secondary	Faecal microbiome diversity	Global microbiota composition (a-diversity, ß-diversity)	week 0 and 4
Secondary	Faecal microbiome	?ndividual phyla, family, genera, species and strains of the faecal gut microbiome (absolute and change).	week 0 and 4
Secondary	Faecal metabolomic profile	Faecal metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance	week 0 and 4
Secondary	Urine metabolomic profile	Urine metabolomic profile (absolute and change) measured using proton nuclear magnetic resonance	week 0 and 4
Secondary	Faecal short-chain fatty acids	Faecal short-chain fatty acids concentration (absolute and change)	week 0 and 4
Secondary	Faecal water content	Faecal water content (absolute and change) measured through lyophilisation	week 0 and 4
Secondary	Faecal pH	Faecal pH (absolute and change)	week 0 and 4
Secondary	Stool output	Assessed using 7-day diaries and the Bristol Stool Form Scale (absolute and change)..	week 0 and 4
Secondary	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	week 0 and 4
Secondary	Gastrointestinal symptoms - PAC-SYM	The validated questionnaire Patient Assessment of Constipation Symptoms (PAC-SYM) will be used (absolute and change).	week 0 and 4
Secondary	Gastrointestinal symptom severity questionnaire - CCCS	The validated questionnaire Cleveland Clinic Constipation Score (CCCS) will be used (absolute and change).	week 0 and 4
Secondary	Dietary intake	Dietary intake (absolute and change) will be recorded in 7-day food and drink diaries	week 0 and 4
Secondary	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".	week 0 and 4
Secondary	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)	week 0 and 4
Secondary	Acceptability of interventions	Acceptability of the interventions measured using a questionnaire that included 3- and 4-point likert scales and open-text answers	week 0 and 4
Secondary	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.	week 0 and 4