Apple Intake Effect on Faecal Metabolome

NCT07499960 | Completed

• 1 other identifier: EK/81/2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot dietary intervention study aimed to investigate whether short-term consumption of apples influences the human faecal metabolomic profile. Apples are a commonly consumed source of dietary fibre, particularly pectin, which undergoes microbial fermentation in the colon and may lead to measurable metabolic changes. Healthy adult volunteers were instructed to consume three apples per day for three consecutive days under free-living conditions. Faecal samples were collected before and after the intervention and analysed using proton nuclear magnetic resonance (¹H NMR) spectroscopy to assess changes in metabolite concentrations. The study sought to explore whether metabolomic profiling can detect functional microbial responses to increased fruit intake and provide preliminary insight into the metabolic impact of short-term dietary fibre exposure.

Conditions

Healthy Adult Participants

Keywords

Apples; Dietary fiber; Pectin fermentation; Faecal metabolome; NMR

Outcome Measures

Primary Outcomes (1)

• Change from baseline in faecal metabolomic profile assessed by ¹H NMR spectroscopy

  The outcome measure represents the change in concentrations of detected faecal metabolites between pre- and post-intervention samples, reflecting potential alterations in gut microbial metabolic activity associated with increased fruit intake.

  Baseline and immediately after completion of the 3-day dietary intervention

Study Arms (1)

Apple Dietary Intervention

EXPERIMENTAL

Participants consumed three fresh apples per day for three consecutive days under free-living conditions while maintaining their habitual diet. Faecal samples were collected before and after the intervention to assess changes in metabolomic profiles.

Other: Apple consumption

Interventions

Apple consumption OTHER

The intervention consisted of short-term added intake of fruit-derived dietary fibre through consumption of three whole apples daily over a three-day period. Participants were asked to maintain habitual dietary patterns apart from the prescribed apple consumption.

Apple Dietary Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18-30 years
• Able and willing to consume apples daily during the intervention period
• Willing to provide stool samples before and after the intervention
• Not following a specific prescribed diet
• Physically able to maintain usual daily activities during the study
• Able to provide written informed consent

You may not qualify if:

• Diagnosed gastrointestinal, metabolic, or chronic systemic disease
• Use of antibiotics, probiotics, or regular medication affecting digestion in the period prior to enrolment
• Known allergy or intolerance to apples or other fruits
• Current participation in another dietary or clinical study
• Following a medically prescribed or restrictive diet
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Czech University of Life Sciences Prague: lead

Study Sites (1)

Czech University of Life Sciences Prague

Prague, Prague, 16500, Czechia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the nature of the dietary intervention, neither participants nor investigators were blinded to the intervention. All participants received the same exposure, and outcome assessment was based on objective metabolomic measurements.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study followed a single-group pre-post intervention design. All participants were exposed to a standardized short-term dietary intervention consisting of daily apple consumption. Outcome assessment was based on paired analysis of pre-intervention and post-intervention faecal metabolomic profiles.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: February 25, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)