Physiological, Microbiological and Metabolomic Effects of Fruit Products

King's College London

Status: Unknown

Conditions: Constipation - Functional

Treatments: Other: Fruit Products

Study type: Interventional

Funder types: Other

Identifiers

NCT04086134

HR-17/18-7858

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Intervention fruit products 1

Experimental group

Description:

Three servings of fruit products per day for 4 weeks.

Treatment:

Other: Fruit Products

Intervention fruit products 2

Experimental group

Description:

Three servings of fruit products per day for 4 weeks.

Treatment:

Other: Fruit Products

Control fruit products

Placebo Comparator group

Description:

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

Treatment:

Other: Fruit Products