HealthyiPROACT-pilotNCT06674018
Indole-3-PROpionic Acid Clinical Trials - a Pilot Study
A study testing Indole-3-propionic acid in people with Healthy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The goal of this pilot intervention trial is to investigate the biological effects of daily supplementation with different doses of indole-3-propionic acid (IPA) in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Indole-3-propionic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Nov 2024to 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women and men ≥18 and ≤65 years of age
- Deemed mentally and physically able to participate
Who cannot join
- Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders
- Use of antibiotics within the last month
- Pregnant or lactating women or birth within the last five months
- Use of medicine that requires prescription
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup
Glostrup Municipality, 2600
About this study
Official title: Indole-3-PROpionic Acid Clinical Trials - a Pilot Study (iPROACT-pilot)
The goal of this pilot intervention trial is to investigate the biological effects of daily supplementation with different doses of indole-3-propionic acid (IPA) in healthy adults. The main scientific questions are:
- Does supplementation with IPA increase the abundance regulatory T cells in the blood? Regulatory T cells are believed to play an important role in preventing autoimmune diseases.
- Does supplementation with IPA increase the concentration of brain-derived neurotrophic factor (BDNF) in the blood? BDNF is believed to play an important role in maintaining brain health.
- Does supplementation with IPA affect blood analyses commonly performed to assess the risk of metabolic disorders like type 2 diabetes and cardiovascular diseases?
- How big a dose of IPA is necessary to achieve the above benefits?
Read more
Participants will:
- Take 50 mg IPA or 120 mg IPA or 500 mg IPA or placebo every morning for 14 days.
- Visit the clinic at the beginning (day 1) and at the end (day 15) of IPA supplementation to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.
Read the detailed description
Indole-3-propionic acid (IPA) is a gut bacterial metabolite with the amino acid tryptophan as substrate. In vitro and animal studies, suggest that IPA could contribute to regulating inflammation and metabolic function, preventing oxidative damage and upregulating expression of brain-derived neurotrophic factor. With this study we aim to investigate the biochemical effects of IPA at supraphysiological levels in humans.
- Conditions
- Healthy
- Being tested
- Indole-3-propionic acid, Placebo
- Keywords
- Indole-3-propionic acid, gut bacterial metabolite, regulatory T cells, brain-derived neurotrophic factor, dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indole-3-propionic acidDietary supplement
A dosis of either 50 mg IPA, 120 mg IPA or 500 mg IPA (two capsules) will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days.
PlaceboDietary supplement
Two capsules of placebo will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| 50 mg IPA | Experimental | 50 mg indole-3-propionic acid Receives: Dietary Supplement: Indole-3-propionic acid |
| 120 mg IPA | Experimental | 120 mg indole-3-propionic acid Receives: Dietary Supplement: Indole-3-propionic acid |
| 500 mg IPA | Experimental | 500 mg indole-3-propionic acid Receives: Dietary Supplement: Indole-3-propionic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regulatory T cells (first primary outcome)
FoxP3+CD25+CD127- regulatory T cells expressed as a percentage of single, live CD3+CD4+CD8- lymphocytes. Analysed in freshly isolated peripheral blood mononuclear cells using a Symphony A3 flowcytometer.
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Brain-derived neurotrophic factor (second primary outcome)
Brain-derived neurotrophic factor measured in plasma samples using ELISA or mesoscale.
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Secondary outcomes (27)
Flowcytometric profiling of T cells
T cell profiling of freshly isolated peripheral blood mononuclear cells using a Symphony A3 flowcytometer. Panel antigens: CD3, CD4, CD8, CD45RA, CCR7, CXCR3, CCR6, CCR4, CCR10, CD25, CD127, FoxP3.
Target populations Th1: CXCR3+CCR4-CCR6-CCR10- Th2: CXCR3-CCR4+CCR6-CCR10- Th17: CXCR3-CCR4+CCR6+CCR10- Th17.1: CXCR3+CCR4-CCR6+CCR10- Th22: CXCR3-CCR4+CCR6+CCR10+ all of the above expressed as a percentage of single, live CD3+CD4+CD8-CD45RA- lymphocytes.
Furthermore, Th1/Th2 and Th17/Treg ratios will be calculated and the expression of CCR7 will be analysed within the target populations.
In addition, the expression of the above chemokine receptors will be explored within the population of FoxP3+CD25+C1D127- T regulatory cells. This will allow for monitoring of newly identified T cells subsets such as Th1-like Tregs.
Lastly, an untargetted approach may be employed to allow for unbiased identification of changes in novel, yet uncharacterized populations.
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
CRP
C-reactive protein (CRP) measured in plasma (mg/L) as a biomarker of infection and systemic inflammation. Lower-limit of quantification: 0,4 mg/L. Values below 0,4 mg/L are imputed as 0,2 mg/L.
Measured: Results from blood samples taken on day 15 (just before last supplement/placebo dosis) and adjusted for results from day 1 (just before first supplement/placebo dosis).
Triglycerides
Plasma triglycerides (mmol/l).
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
non-HDL cholesterol
Non-HDL cholesterol calculated as total cholesterol minus HDL cholesterol (mmol/l)
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
C-peptide
Proinsulin C-peptide (pmol/l) measured in plasma.
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Fasting glucose
Plasma glucose (mmol/l). Participants abstain from eating and drinking after 22.00 the day before. Only water is allowed. Fasting blood samples are taken between 8.00-10.00 in the morning.
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Isoprostane-F2-alpha
Isoprostane-F2-alpha measured in blood or morningurine samples as a marker of lipid oxidation.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
8-oxo-dG
8-oxo-dG (8-Oxo-2'-deoxyguanosine) measured in blood or morningurine samples as a marker of DNA-related stress damage.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Serum metabolomics
Targetted and untargetted liquid-chromatography mass-spectrometry-based metabolomics of serum samples. Targetted analyses aim to quantify indole-3-propionic acid and its metabolites (biomarker of compliance as well as absorptive and metabolic capacity), other bacterial- and host metabolites of tryptophan as well as short-chain fatty acids.
Measured: Four samples in total. Day 1 prior to and again 1.5 hour after intake of first capsule of IPA/ placeblo. Day 15 prior to and again 1.5 hour after intake of last capsule of IPA/ placebo.
Total cholesterol
Plasma cholesterol (mmol/l).
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
VLDL cholesterol
Plasma very low-density lipoproteins (mmol/l).
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
LDL cholesterol
Plasma low-density lipoprotein (LDL) (mmol/l).
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
HDL cholesterol
Plasma high-density lipoprotein (HDL) (mmol/l).
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Malondialdehyde
Malondialdehyde measured in blood or morningurine samples as a marker of oxidative stress.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Protein carbonyls
Protein carbonyls measured in blood or morningurine samples as a marker of protein oxidation.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Glycated hemoglobin (HbA1c)
HbA1c (IFCC, mmol/mol) measured in whole blood. Estimated average glucose values (mmol/l) are also calculated automatically from HbA1c by our laboratory.
Measured: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Changes in the gut microbiome
Characterization of the gut microbiome using molecular biology methods such as 16s rRNA sequencing.
Measured: Fecal samples are collected at three time points: prior to supplementation (earliest 48 hours prior to first visit (day 1)), short after initiation of supplementation (day 3 or soonest thereafter) and again earliest 48 hours prior to last visit.
Characterization of the metabolic activity of the gut microbiota
Targetted and untargetted liquid-chromatography mass-spectrometry-based metabolomics. Targetted analyses aim to quantify indole-3-propionic acid, other bacterial- and host metabolites of tryptophan as well as short-chain fatty acids.
Measured: Fecal samples are collected at three time points: prior to supplementation (earliest 48 hours prior to first visit (day 1)), short after initiation of supplementation (day 3 or soonest thereafter) and again earliest 48 hours prior to last visit.
Bacterial polysaccharides
Endotoxin, capsular polysaccharides or other bacterial polysaccharides measured in blood samples as biomarker of bacterial translocation across the intestinal epithelium.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Pre-haptoglobin 2
Measurement of pre-haptoglobin 2 in blood samples as a biomarker of intestinal permeability.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Intestinal fatty acid binding protein
Measurements of intestinal fatty acid binding protein in blood samples as a biomarker of enterocyte damage.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Citrulline
Measurement of citrulline in blood samples as a biomarker of intestinal function.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Calprotectin
Calprotectin measured in fecal samples as a biomarker of intestinal inflammation.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Neopterin
Neopterin measured in morningurine samples as a biomarker of systemic inflammation.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
suPAR
Soluble urokinase plasminogen activator receptor (suPAR) measured in blood samples.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Microvesicles
Flow cytometric analyses of microvesicles/ microparticles in platelet-free plasma as biomarker of systemic inflammation.
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Endothelial progenitor cells
Flow cytometric analyses of endothelial progenitor cells measured in platelet-free plasma as biomarker of systemic inflammation
Measured: Results from samples taken on day 15 and adjusted for results from day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start14 Nov 2024
- Primary completion25 Feb 2025
- 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 HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Southampton
- Responsible party
- Principal investigator, Jette Lautrup Frederiksen, Glostrup University Hospital, Copenhagen
- Investigators
- Jette Lautrup Frederiksen, Prof, DMSc, MD, Principal investigator, Jette Lautrup Frederiksen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674018
- Sponsor's protocol ID
- H-24008127
- Acronym
- iPROACT-pilot
- Status last verified
- Mar 2025
- First submitted
- 2 Nov 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indole-3-PROpionic Acid Clinical Trials - a Pilot Study (iPROACT-pilot)
- ClinicalTrials.gov ID
- NCT06674018
- Acronym / sponsor ID
- iPROACT-pilot / H-24008127
- Conditions
- Healthy
- Keywords
- Indole-3-propionic acid, gut bacterial metabolite, regulatory T cells, brain-derived neurotrophic factor, dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Southampton
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 5 Nov 2024 (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.
The goal of this pilot intervention trial is to investigate the biological effects of daily supplementation with different doses of indole-3-propionic acid (IPA) in healthy adults. The main scientific questions are:
- Does supplementation with IPA increase the abundance regulatory T cells in the blood? Regulatory T cells are believed to play an important role in preventing autoimmune diseases.
- Does supplementation with IPA increase the concentration of brain-derived neurotrophic factor (BDNF) in the blood? BDNF is believed to play an important role in maintaining brain health.
- Does supplementation with IPA affect blood analyses commonly performed to assess the risk of metabolic disorders like type 2 diabetes and cardiovascular diseases?
- How big a dose of IPA is necessary to achieve the above benefits?
Participants will:
- Take 50 mg IPA or 120 mg IPA or 500 mg IPA or placebo every morning for 14 days.
- Visit the clinic at the beginning (day 1) and at the end (day 15) of IPA supplementation to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.
Detailed description
Indole-3-propionic acid (IPA) is a gut bacterial metabolite with the amino acid tryptophan as substrate. In vitro and animal studies, suggest that IPA could contribute to regulating inflammation and metabolic function, preventing oxidative damage and upregulating expression of brain-derived neurotrophic factor. With this study we aim to investigate the biochemical effects of IPA at supraphysiological levels in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| 50 mg IPA | Experimental | Dietary Supplement: Indole-3-propionic acid50 mg indole-3-propionic acid |
| 120 mg IPA | Experimental | Dietary Supplement: Indole-3-propionic acid120 mg indole-3-propionic acid |
| 500 mg IPA | Experimental | Dietary Supplement: Indole-3-propionic acid500 mg indole-3-propionic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy women and men ≥18 and ≤65 years of age
- Deemed mentally and physically able to participate
Key exclusion criteria (4 listed)
- Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders
- Use of antibiotics within the last month
- Pregnant or lactating women or birth within the last five months
- Use of medicine that requires prescription
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 |
|---|---|---|
| Indole-3-propionic acidA dosis of either 50 mg IPA, 120 mg IPA or 500 mg IPA (two capsules) will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days. | Dietary supplement | 120 mg IPA, 50 mg IPA, 500 mg IPA |
| PlaceboTwo capsules of placebo will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days. | Dietary supplement | Placebo |
Primary outcome
Regulatory T cells (first primary outcome)
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
FoxP3+CD25+CD127- regulatory T cells expressed as a percentage of single, live CD3+CD4+CD8- lymphocytes. Analysed in freshly isolated peripheral blood mononuclear cells using a Symphony A3 flowcytometer.
Brain-derived neurotrophic factor (second primary outcome)
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Brain-derived neurotrophic factor measured in plasma samples using ELISA or mesoscale.
27 secondary outcomes
Flowcytometric profiling of T cells
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
CRP
Time frame: Results from blood samples taken on day 15 (just before last supplement/placebo dosis) and adjusted for results from day 1 (just before first supplement/placebo dosis).
Triglycerides
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
non-HDL cholesterol
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
C-peptide
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Fasting glucose
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Isoprostane-F2-alpha
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
8-oxo-dG
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Serum metabolomics
Time frame: Four samples in total. Day 1 prior to and again 1.5 hour after intake of first capsule of IPA/ placeblo. Day 15 prior to and again 1.5 hour after intake of last capsule of IPA/ placebo.
Total cholesterol
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
VLDL cholesterol
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
LDL cholesterol
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
HDL cholesterol
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Malondialdehyde
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Protein carbonyls
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Glycated hemoglobin (HbA1c)
Time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).
Changes in the gut microbiome
Time frame: Fecal samples are collected at three time points: prior to supplementation (earliest 48 hours prior to first visit (day 1)), short after initiation of supplementation (day 3 or soonest thereafter) and again earliest 48 hours prior to last visit.
Characterization of the metabolic activity of the gut microbiota
Time frame: Fecal samples are collected at three time points: prior to supplementation (earliest 48 hours prior to first visit (day 1)), short after initiation of supplementation (day 3 or soonest thereafter) and again earliest 48 hours prior to last visit.
Bacterial polysaccharides
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Pre-haptoglobin 2
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Intestinal fatty acid binding protein
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Citrulline
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Calprotectin
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Neopterin
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
suPAR
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Microvesicles
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
Endothelial progenitor cells
Time frame: Results from samples taken on day 15 and adjusted for results from day 1.
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 5 Mar 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).
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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.
Jette Lautrup Frederiksen, Prof, DMSc, MD principal investigator
Jette Lautrup Frederiksen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indole-3-propionic acid in people with Healthy, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 2 inclusion and 4 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 5 Mar 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 Denmark. 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?
Regulatory T cells (first primary outcome) (time frame: Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).). 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 5 Mar 2025.