Metabolic EffectsMETAKIDNCT06951581
Impact of SCFA Supplementation on Metabolic Profiles in Serum and Urine of Kidney Transplant Recipients.
A study testing Short Chain Fatty Acid in people with Metabolic Effects and Immunosuppressive Agents, run by University Hospital, Martin at 1 site in Slovakia.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical trial evaluating the impact of short-chain fatty acid (SCFA) supplementation on the serum and urinary metabolome in stable kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Effects, Immunosuppressive Agents, Adverse Events
- What is being tested?
- Short Chain Fatty Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Jan 2024to 30 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Stable kidney transplant recipients (≥ 6 months post-transplantation)
- Stable graft function defined as eGFR ≥ 30 mL/min/1.73 m² with no significant change (>15%) in the last 3 months
- No episodes of acute rejection within the last 6 months
- On stable immunosuppressive therapy for at least 3 months
- Ability to provide written informed consent
- Willingness and ability to comply with study procedures and sample collection
Who cannot join
- Use of antibiotics or probiotics within 4 weeks prior to enrollment
- Known gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, short bowel syndrome)
- Uncontrolled diabetes mellitus (HbA1c > 9%)
- Current infection or active malignancy
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within the past 30 days
Show all 9Show fewer
- Known allergy or intolerance to SCFA formulations or study components (lactose intolerance)
- Severe hepatic impairment (Child-Pugh class C)
- Any condition that, in the opinion of the investigator, may interfere with the participant's ability to complete the study or affect the interpretation of results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled Trial Investigating the Effect of Short-chain Fatty Acid (SCFA) Supplementation on Serum and Urinary Metabolome in Kidney Transplant Recipients (METAKID Study)
This is a randomized, double-blind, placebo-controlled clinical trial evaluating the impact of short-chain fatty acid (SCFA) supplementation on the serum and urinary metabolome in stable kidney transplant recipients. A total of eligible patients will be randomized 1:1 to receive either SCFA or placebo for a period of 12 weeks. Metabolomic profiling of serum and urine will be performed at three time points: at baseline, after 12 weeks of intervention, and after a 12-week washout period without supplementation. The primary objective of the study is to investigate whether SCFA supplementation leads to measurable changes in systemic and renal metabolomic profiles. Secondary outcomes include assessment of tolerability, safety, and potential immunometabolic correlations and also impact on the serum level of immunossupresants (tacrolimus). This study aims to explore the potential of microbiota-targeted therapies in modulating post-transplant metabolic homeostasis.
- Conditions
- Metabolic Effects, Immunosuppressive Agents, Adverse Events, Imunological Effects, Inflamatory Markers, Metabolomic Effects
- Being tested
- Short Chain Fatty Acid, Placebo Capsule(s)
- Keywords
- short chain fatty acids, urine and serum metabolomics, kidney transplant recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Chain Fatty AcidDietary supplement
Participants in this arm will receive an oral formulation of short-chain fatty acids (SCFAs) daily for 12 weeks. SCFAs are administered as a dietary supplement to investigate their potential impact on the systemic and urinary metabolome in kidney transplant recipients.
Placebo Capsule(s)Dietary supplement
Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day.
| Study group | Role | What they receive |
|---|---|---|
| SCFA Group | Active comparator | Participants will receive an oral formulation of short-chain fatty acids (SCFA) in dose 200 mg daily for 12 weeks Receives: Dietary Supplement: Short Chain Fatty Acid |
| Placebo Group | Placebo comparator | Participants will receive a placebo orally (sacharosis in dose 200 mg), matching the SCFA formulation in appearance and administration schedule, for 12 weeks. Receives: Dietary Supplement: Placebo Capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of serum metabolites after SCFA supplementation
Quantitative and qualitative changes in the concentration of serum metabolites assessed using targeted metabolomic techniques NMR.
Measured: Baseline to Week 12 and Week 12 to washout period
Change in concentration of urine metabolites after SCFA supplementation
Quantitative and qualitative changes in the concentration of urine metabolites assessed using targeted metabolomic techniques NMR.
Measured: Baseline to Week 12 and Week 12 to washout period
Secondary outcomes (7)
Incidence of adverse events (AEs) in the contexte of SCFA supplementation
Number, type, and severity of AEs assessed through questionnaire, clinical assessment, and lab tests.
Measured: Baseline to Week 12
Change in inflammatory biomarkers
Exploratory analysis of inflammatory markers (CRP, leukocytosis) to assess potential immunomodulatory effects of SCFA.
Measured: Baseline to Week 12
Changes in estimated glomerular filtration rate (eGFR).
Monitoring renal function using eGFR (ml/min/1.73m2) calculated by CKD-EPI.
Measured: Baseline to Week 12 and Week 24
Tolerability of SCFA supplementation
The patient tolerability of SCFA suplementation or placebo assessed through questionnaire.
Measured: Baseline to Week 12
Change in immunological biomarkers
Exploratory analysis of immunological markers (T cell subsets) to assess potential immunomodulatory effects of SCFA.
Measured: Baseline to Week 12
Changes in urine albumine cretinine ratio (UACR).
Monitoring renal function using UACR in the context of using SCFA or placebo.
Measured: Baseline to Week 12 and Week 24
Changes in the serum level of tacrolimus.
Monitoring the serum level of tacrolimus (ng/l) in the context of SCFA supplementation.
Measured: Baseline to Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start15 Jan 2024
- Primary completion15 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic EffectsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951581
- Sponsor's protocol ID
- TNO_UNM_SCFA1
- Acronym
- METAKID
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Trial Investigating the Effect of Short-chain Fatty Acid (SCFA) Supplementation on Serum and Urinary Metabolome in Kidney Transplant Recipients (METAKID Study)
- ClinicalTrials.gov ID
- NCT06951581
- Acronym / sponsor ID
- METAKID / TNO_UNM_SCFA1
- Conditions
- Metabolic Effects, Immunosuppressive Agents, Adverse Events, Imunological Effects, Inflamatory Markers, Metabolomic Effects
- Keywords
- short chain fatty acids, urine and serum metabolomics, kidney transplant recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Collaborators
- Comenius University
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 30 Apr 2025 (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 is a randomized, double-blind, placebo-controlled clinical trial evaluating the impact of short-chain fatty acid (SCFA) supplementation on the serum and urinary metabolome in stable kidney transplant recipients. A total of eligible patients will be randomized 1:1 to receive either SCFA or placebo for a period of 12 weeks. Metabolomic profiling of serum and urine will be performed at three time points: at baseline, after 12 weeks of intervention, and after a 12-week washout period without supplementation. The primary objective of the study is to investigate whether SCFA supplementation leads to measurable changes in systemic and renal metabolomic profiles. Secondary outcomes include assessment of tolerability, safety, and potential immunometabolic correlations and also impact on the serum level of immunossupresants (tacrolimus). This study aims to explore the potential of microbiota-targeted therapies in modulating post-transplant metabolic homeostasis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCFA Group | Active comparator | Dietary Supplement: Short Chain Fatty AcidParticipants will receive an oral formulation of short-chain fatty acids (SCFA) in dose 200 mg daily for 12 weeks |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo Capsule(s)Participants will receive a placebo orally (sacharosis in dose 200 mg), matching the SCFA formulation in appearance and administration schedule, for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Stable kidney transplant recipients (≥ 6 months post-transplantation)
- Stable graft function defined as eGFR ≥ 30 mL/min/1.73 m² with no significant change (>15%) in the last 3 months
- No episodes of acute rejection within the last 6 months
- On stable immunosuppressive therapy for at least 3 months
Key exclusion criteria (9 listed)
- Use of antibiotics or probiotics within 4 weeks prior to enrollment
- Known gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, short bowel syndrome)
- Uncontrolled diabetes mellitus (HbA1c > 9%)
- Current infection or active malignancy
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Short Chain Fatty AcidParticipants in this arm will receive an oral formulation of short-chain fatty acids (SCFAs) daily for 12 weeks. SCFAs are administered as a dietary supplement to investigate their potential impact on the systemic and urinary metabolome in kidney transplant recipients. | Dietary supplement | SCFA Group |
| Placebo Capsule(s)Oral capsules with sacharosa (200 mg) matching SCFA appearance, administered once a day. | Dietary supplement | Placebo Group |
Primary outcome
Change in concentration of serum metabolites after SCFA supplementation
Time frame: Baseline to Week 12 and Week 12 to washout period
Quantitative and qualitative changes in the concentration of serum metabolites assessed using targeted metabolomic techniques NMR.
Change in concentration of urine metabolites after SCFA supplementation
Time frame: Baseline to Week 12 and Week 12 to washout period
Quantitative and qualitative changes in the concentration of urine metabolites assessed using targeted metabolomic techniques NMR.
7 secondary outcomes
Incidence of adverse events (AEs) in the contexte of SCFA supplementation
Time frame: Baseline to Week 12
Change in inflammatory biomarkers
Time frame: Baseline to Week 12
Changes in estimated glomerular filtration rate (eGFR).
Time frame: Baseline to Week 12 and Week 24
Tolerability of SCFA supplementation
Time frame: Baseline to Week 12
Change in immunological biomarkers
Time frame: Baseline to Week 12
Changes in urine albumine cretinine ratio (UACR).
Time frame: Baseline to Week 12 and Week 24
Changes in the serum level of tacrolimus.
Time frame: Baseline to Week 12 and Week 24
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 12 Jun 2025.
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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 Short Chain Fatty Acid in people with Metabolic Effects and Immunosuppressive Agents, run by University Hospital, Martin at 1 site in Slovakia.
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 7 inclusion and 9 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 12 Jun 2025. 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 Slovakia. 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. Some participants in this study may receive a placebo. 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 in concentration of serum metabolites after SCFA supplementation (time frame: Baseline to Week 12 and Week 12 to washout period). The study lists 2 primary outcomes in all. 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 12 Jun 2025.