Healthy Adult ParticipantsAppleNMRNCT07499960
Apple Intake Effect on Faecal Metabolome
A study testing Apple consumption in people with Healthy Adult Participants, run by Czech University of Life Sciences Prague at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Apple consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2023to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Short-term Apple Intake on the Human Faecal Metabolome Assessed by 1H NMR Spectroscopy
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.
Read the 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.
- Conditions
- Healthy Adult Participants
- Being tested
- Apple consumption
- Keywords
- Apples, Dietary fiber, Pectin fermentation, Faecal metabolome, NMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple consumptionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Apple consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after completion of the 3-day dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2023
- Primary completion30 Aug 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech University of Life Sciences Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaroslav Havlik, Czech University of Life Sciences Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499960
- Sponsor's protocol ID
- EK/81/2023
- Acronym
- AppleNMR
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level participant data will not be publicly shared due to privacy considerations and ethical restrictions. De-identified summary data supporting the study findings may be available from the investigators upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Short-term Apple Intake on the Human Faecal Metabolome Assessed by 1H NMR Spectroscopy
- ClinicalTrials.gov ID
- NCT07499960
- Acronym / sponsor ID
- AppleNMR / EK/81/2023
- Conditions
- Healthy Adult Participants
- Keywords
- Apples, Dietary fiber, Pectin fermentation, Faecal metabolome, NMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Czech University of Life Sciences PragueUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Apple Dietary Intervention | Experimental | Other: Apple consumptionParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple consumptionThe 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. | Other | Apple Dietary Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. Individual-level participant data will not be publicly shared due to privacy considerations and ethical restrictions. De-identified summary data supporting the study findings may be available from the investigators upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple consumption in people with Healthy Adult Participants, run by Czech University of Life Sciences Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.