Physiological, Microbiological and Metabolomic Effects of Fruit Products

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation - Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention fruit products 1

Three servings of fruit products per day for 4 weeks.

Group Type EXPERIMENTAL

Fruit Products

Intervention Type OTHER

Fruit Products with the potential to improve constipation-related outcomes

Intervention fruit products 2

Three servings of fruit products per day for 4 weeks.

Group Type EXPERIMENTAL

Fruit Products

Intervention Type OTHER

Fruit Products with the potential to improve constipation-related outcomes

Control fruit products

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

Group Type PLACEBO_COMPARATOR

Fruit Products

Intervention Type OTHER

Fruit Products with the potential to improve constipation-related outcomes

Interventions

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Fruit Products

Fruit Products with the potential to improve constipation-related outcomes

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No