- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07499960
Apple Intake Effect on Faecal Metabolome (AppleNMR)
Impact of Short-term Apple Intake on the Human Faecal Metabolome Assessed by 1H NMR Spectroscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was designed as a single-arm exploratory dietary intervention to evaluate short-term metabolic responses to increased intake of fruit-derived dietary fibre. Participants were instructed to consume three fresh Gala apples per day for three consecutive days while otherwise maintaining their habitual diet and lifestyle. The intervention was conducted under free-living conditions to reflect realistic dietary behaviour.
Faecal samples were collected immediately before the intervention and after completion of the three-day exposure period. Samples were processed using standardized laboratory protocols to obtain aqueous extracts suitable for metabolomic analysis. Proton nuclear magnetic resonance (¹H NMR) spectroscopy was employed to generate quantitative metabolic profiles, enabling detection of metabolites associated with microbial fermentation and host-microbe metabolic interactions.
Metabolite concentrations were quantified using targeted profiling approaches, and both multivariate and univariate statistical analyses were applied to assess intervention-related changes in the faecal metabolome. The study was intended to provide mechanistic insight into how short-term consumption of a commonly consumed fruit may influence gut microbial metabolic activity, and to evaluate the feasibility of metabolomics-based assessment of dietary exposures in small-scale human intervention studies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Prague
-
Prague, Prague, Czechia, 16500
- Czech University of Life Sciences Prague
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Apple Dietary Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in faecal metabolomic profile assessed by ¹H NMR spectroscopy
Time Frame: Baseline and immediately after completion of the 3-day dietary intervention
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EK/81/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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