[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601055":3},{"organization":4,"outcomesModule":7,"designInfo":182,"detailedDescription":195,"studyPopulation":185,"armGroups":196,"interventions":208,"overallOfficials":216,"centralContacts":221,"locations":227,"responsibleParty":247,"collaborators":250,"id":255,"slug":185,"hasResults":256,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":262,"sex":263,"minAge":264,"maxAge":265,"enrollmentInfo":266,"targetDuration":185,"studyType":269,"phases":270,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":230,"whyStopped":185,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},{"fullName":5,"class":6},"Glostrup University Hospital, Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":111},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement\u002Fplacebo dose).",{"measure":14,"description":15,"timeFrame":12},"Brain-derived neurotrophic factor (second primary outcome)","Brain-derived neurotrophic factor measured in platelet-free plasma samples using ELISA or mesoscale.",[17,20,23,26,30,33,36,39,42,46,49,53,56,59,62,65,68,71,74,77,81,84,87,90,93,96,99,102,105,108],{"measure":18,"description":19,"timeFrame":12},"Th1\u002FTh2 ratio in PBMCs","Th1\u002FTh2 ratio calculated from T cell profiling of freshly isolated peripheral blood mononuclear cells (PBMCs) using a Symphony A3 flowcytometer.\n\nTh1 cells are defined as the CXCR3+CCR4-CCR6-CCR10- non-Treg population and expressed as a percentage of single, live CD3+CD4+CD8-CD45RA- lymphocytes.\n\nTh2 cells are defined as the CXCR3-CCR4+CCR6-CCR10- non-Treg population and expressed as a percentage of single, live CD3+CD4+CD8-CD45RA- lymphocytes.\n\nPanel antigens: FVS780, CD3, CD4, CD8, CD45RA, CCR7, CXCR3, CCR6, CCR4, CCR10, CD25, CD127, FoxP3.",{"measure":21,"description":22,"timeFrame":12},"Th17\u002FmTreg ratio in PBMCs","Th17\u002FmTreg ratio calculated from T cell profiling of freshly isolated peripheral blood mononuclear cells (PBMCs) using a Symphony A3 flowcytometer.\n\nTh17 cells are defined as the CXCR3-CCR4+CCR6+CCR10- non-Treg population and expressed as a percentage of single, live CD3+CD4+CD8-CD45RA- lymphocytes.\n\nmTreg (memory Tregs) are defined as the FoxP3+CD25+CD127-CD45RA- population and expressed as a percentage of single, live CD3+CD4+CD8-CD45RA- lymphocytes\n\nPanel antigens: FVS780, CD3, CD4, CD8, CD45RA, CCR7, CXCR3, CCR6, CCR4, CCR10, CD25, CD127, FoxP3.",{"measure":24,"description":25,"timeFrame":12},"Th17.1 cells in PBMCs","Th17.1 cells in freshly isolated peripheral blood mononuclear cells (PBMCs) characterized using a Symphony A3 flowcytometer.\n\nTh17.1 cells are defined as the CXCR3+CCR4-CCR6+CCR10- non-Treg population and expressed as a percentage of single, live CD3+CD4+CD8-CD45RA- lymphocytes\n\nPanel antigens: FVS780, CD3, CD4, CD8, CD45RA, CCR7, CXCR3, CCR6, CCR4, CCR10, CD25, CD127, FoxP3.",{"measure":27,"description":28,"timeFrame":29},"CRP","C-reactive protein (CRP) measured in plasma (mg\u002FL) as a biomarker of infection and systemic inflammation. Lower-limit of quantification: 0,4 mg\u002FL. Values below 0,4 mg\u002FL are imputed as 0,2 mg\u002FL.","Results from blood samples taken on day 15 (just before last supplement\u002Fplacebo dose) and adjusted for results from day 1 (just before first supplement\u002Fplacebo dose).",{"measure":31,"description":32,"timeFrame":12},"Triglycerides","Plasma triglycerides (mmol\u002Fl).",{"measure":34,"description":35,"timeFrame":12},"non-HDL cholesterol","Non-HDL cholesterol calculated as total cholesterol minus HDL cholesterol (mmol\u002Fl)",{"measure":37,"description":38,"timeFrame":12},"C-peptide","Proinsulin C-peptide (pmol\u002Fl) measured in plasma.",{"measure":40,"description":41,"timeFrame":12},"Fasting glucose","Plasma glucose (mmol\u002Fl). 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.",{"measure":43,"description":44,"timeFrame":45},"F2-isoprostanes","F2-isoprostanes with a specific focus on 8-iso-prostaglandin F2α measured in blood or morningurine samples as a marker of lipid oxidation.","Results from samples taken on day 15 and adjusted for results from day 1.",{"measure":47,"description":48,"timeFrame":45},"8-oxo-dG","8-oxo-dG (8-Oxo-2'-deoxyguanosine) measured in blood or morningurine samples as a marker of DNA-related stress damage.",{"measure":50,"description":51,"timeFrame":52},"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.","Four samples in total. Day 1 prior to and again 1.5 hour after intake of first capsule of IPA\u002F placeblo. Day 15 prior to and again 1.5 hour after intake of last capsule of IPA\u002F placebo.",{"measure":54,"description":55,"timeFrame":12},"Total cholesterol","Plasma cholesterol (mmol\u002Fl).",{"measure":57,"description":58,"timeFrame":12},"VLDL cholesterol","Plasma very low-density lipoproteins (mmol\u002Fl).",{"measure":60,"description":61,"timeFrame":12},"LDL cholesterol","Plasma low-density lipoprotein (LDL) (mmol\u002Fl).",{"measure":63,"description":64,"timeFrame":12},"HDL cholesterol","Plasma high-density lipoprotein (HDL) (mmol\u002Fl).",{"measure":66,"description":67,"timeFrame":45},"Malondialdehyde","Malondialdehyde measured in blood or morningurine samples as a marker of oxidative stress.",{"measure":69,"description":70,"timeFrame":45},"Protein carbonyls","Protein carbonyls measured in blood or morningurine samples as a marker of protein oxidation.",{"measure":72,"description":73,"timeFrame":12},"Glycated hemoglobin (HbA1c)","HbA1c (IFCC, mmol\u002Fmol) measured in whole blood. Estimated average glucose values (mmol\u002Fl) are also calculated automatically from HbA1c by our laboratory.",{"measure":75,"description":76,"timeFrame":12},"T cell profiling","Targetted and untargetted T cell profiling of freshly isolated peripheral blood mononuclear cells (PBMCs) using a Symphony A3 flowcytometer. Panel antigens: FVS780, CD3, CD4, CD8, CD45RA, CCR7, CXCR3, CCR6, CCR4, CCR10, CD25, CD127, FoxP3.\n\nTarget populations:\n\nNaïve: CD45RA+CCR7+, Central memory: CD45RA-CCR7+, Effector memory: CD45RA-CCR7-, TEMRA: CD45RA+CCR7-, 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+, as well as expression of chemokine receptors on cytotoxic T cells and regulatory T cells.\n\nAn untargetted approach may be employed to allow for unbiased identification of changes in novel, yet uncharacterized populations.",{"measure":78,"description":79,"timeFrame":80},"Changes in the gut microbiome","Characterization of the gut microbiome using molecular biology methods such as 16s rRNA sequencing.","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.",{"measure":82,"description":83,"timeFrame":80},"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.",{"measure":85,"description":86,"timeFrame":45},"Bacterial polysaccharides","Endotoxin, capsular polysaccharides or other bacterial polysaccharides measured in blood samples as biomarker of bacterial translocation across the intestinal epithelium.",{"measure":88,"description":89,"timeFrame":45},"Pre-haptoglobin 2","Measurement of pre-haptoglobin 2 in blood samples as a biomarker of intestinal permeability.",{"measure":91,"description":92,"timeFrame":45},"Intestinal fatty acid binding protein","Measurements of intestinal fatty acid binding protein in blood samples as a biomarker of enterocyte damage.",{"measure":94,"description":95,"timeFrame":45},"Citrulline","Measurement of citrulline in blood samples as a biomarker of intestinal function.",{"measure":97,"description":98,"timeFrame":45},"Calprotectin","Calprotectin measured in fecal samples as a biomarker of intestinal inflammation.",{"measure":100,"description":101,"timeFrame":45},"Neopterin","Neopterin measured in morningurine samples as a biomarker of systemic inflammation.",{"measure":103,"description":104,"timeFrame":45},"suPAR","Soluble urokinase plasminogen activator receptor (suPAR) measured in blood samples.",{"measure":106,"description":107,"timeFrame":45},"Microvesicles","Flow cytometric analyses of microvesicles\u002F microparticles in platelet-free plasma as biomarker of systemic inflammation.",{"measure":109,"description":110,"timeFrame":45},"Endothelial progenitor cells","Flow cytometric analyses of endothelial progenitor cells measured in platelet-free plasma as biomarker of systemic inflammation",[112,116,120,124,128,131,135,138,141,144,147,150,153,156,159,162,166,169,172,175,178],{"measure":113,"description":114,"timeFrame":115},"Gastrointestinal comfort","Self-reported (questionnaire) gastrointestinal symptoms of bloating, pain, rumbling, flatulence, constipation, hard stools and diarrhea evaluated using a visual analogue scale as well as a question on the frequency of defecation.","Gastrointestinal symptoms are assessed on day 1 and day 15.",{"measure":117,"description":118,"timeFrame":119},"Gastrointestinal transit time","Measurement of transit time through the digestive system using a so-called maize test. Participants consume 100 grams of sweet maize in the morning between 5.30-10.00 while still in a fasting state. The exact date and time of consumption is registered and so is the exact date and time when maize is observed for the first time in feces. Transit time is expressed as the difference between the ingestion and fecal excretion timepoints in hours.","The maize test is performed at baseline (maize is ingested five days before visit 1) and repeated on day 10 (five days before visit 2).",{"measure":121,"description":122,"timeFrame":123},"Stool consistency","Classification of stool consistency using the Bristol Stool Chart. Numerical scale ranging from 1 (separate hard lumps) to 7 (liquid consistency with no solid pieces) with one-unit increments.","Bristol stool chart is used in association with each maize test and collection of fecal samples (earliest 48 hours prior to first visit and day 3 or soonest thereafter and again earliest 48 hours prior to last visit (day 15)).",{"measure":125,"description":126,"timeFrame":127},"Fecal pH","pH of collected fecal samples","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 (day 15).",{"measure":129,"description":130,"timeFrame":127},"Antibody-coating of bacteria","Characterization of IgA, IgG and IgM-coating of bacteria from fecal samples using bacterial flow cytometry.",{"measure":132,"description":133,"timeFrame":134},"Immunoglobulin G","Plasma immunoglobulin G (g\u002Fl)","Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (just before first supplement\u002Fplacebo dose).",{"measure":136,"description":137,"timeFrame":29},"Immunoglobulin A","Plasma immunoglobulin A (g\u002Fl)",{"measure":139,"description":140,"timeFrame":134},"Leucocyte counts","Total leucocytes as well as basophils, eosinophils, lymphocytes, monocytes, neutrophils as well as the joint group of metamyelo-, myelo- and promyelocytes. All counted in whole blood samples (10\\^9\u002Fl).",{"measure":142,"description":143,"timeFrame":29},"Hemoglobin","Hemoglobin measured in whole blood (mmol\u002Fl).",{"measure":145,"description":146,"timeFrame":12},"Alanine transaminase","Plasma alanine transaminase (ALT, U\u002Fl) as a biomarker of liver function.",{"measure":148,"description":149,"timeFrame":29},"Alkaline phosphatase","Alkaline phosphatase (U\u002Fl) as a biomarker of liver function.",{"measure":151,"description":152,"timeFrame":29},"Aspartate aminotransferase","Aspartate aminotransferase also known as aspartate transaminase measured in plasma (U\u002Fl) as a biomarker of liver damage.",{"measure":154,"description":155,"timeFrame":29},"Bilirubin","Bilirubins measured in plasma (µmol\u002FL) as a biomarker of liver function.",{"measure":157,"description":158,"timeFrame":29},"Coagulation factors II + VII + X","Coagulation factors II + VII + X (INR: International Normalized Ratio) measured in plasma as a biomarker of liver function.",{"measure":160,"description":161,"timeFrame":29},"Lactate dehydrogenase (LDH)","Lactate dehydrogenase measured in plasma (U\u002Fl).",{"measure":163,"description":164,"timeFrame":165},"Creatinine","Plasma creatinine (µmol\u002FL) as a biomarker of kidney function.","Results from blood samples taken on day 15 (just before last supplement\u002Fplacebo dose) and adjusted for results from day 1 (just before first supplement\u002Fplacebo dose)",{"measure":167,"description":168,"timeFrame":29},"eGFR","Estimated glomerular filtration rate (eGFR\u002F 1,73m² (ml\u002Fmin)) as a biomarker of kidney function.",{"measure":170,"description":171,"timeFrame":29},"Albumin","Albumin measured in plasma (g\u002Fl).",{"measure":173,"description":174,"timeFrame":29},"25-OH-vitamin D","Plasma 25-OH-vitamin D (D3+D2) (nmol\u002FL)",{"measure":176,"description":177,"timeFrame":29},"TSH","Thyroid-stimulating hormone (TSH) measured in plasma (mU\u002FL)",{"measure":179,"description":180,"timeFrame":181},"Blood pressure","Blood pressure (mm Hg) defined as the lowest value obtained across three measurements.","Measured on day 1 and then again on day 15",{"allocation":183,"interventionModel":184,"interventionModelDescription":185,"primaryPurpose":186,"observationalModel":185,"timePerspective":185,"maskingInfo":187},"RANDOMIZED","PARALLEL",null,"BASIC_SCIENCE",{"masking":188,"maskingDescription":189,"whoMasked":190},"QUADRUPLE","Randomization is performed by external party. Each capsule container is labelled with a unique number (101-160) and no other identifier. Capsule containers have already been randomized by the external party using block randomization with random block sizes of 2 or 4. Study participants receive the next available capsule container based on their order of recruitment. This way, everyone involved in the study is fully blinded and it is also impossible to guess which participants belong to the same group. Only after all study participants have been recruited and the collected data have been cleaned and quality checked, are the researchers performing the statistical analyses informed about which participants belong to the same group.",[191,192,193,194],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.",[197,202],{"label":198,"type":199,"description":198,"interventionNames":200},"Placebo","PLACEBO_COMPARATOR",[201],"Dietary Supplement: Placebo",{"label":203,"type":204,"description":205,"interventionNames":206},"Indole-3-propionic acid (IPA)","EXPERIMENTAL","IPA: total daily dose of 1000 mg",[207],"Dietary Supplement: Indole-3-propionic acid (IPA)",[209,213],{"type":210,"name":203,"description":211,"armGroupLabels":212,"otherNames":185},"DIETARY_SUPPLEMENT","Two capsules are taken every morning and two capsules are taken every evening for 14 consecutive days. Active capsules are taken orally and contain 250 mg of IPA each.",[203],{"type":210,"name":198,"description":214,"armGroupLabels":215,"otherNames":185},"Two capsules are taken every morning and two capsules are taken every evening for 14 consecutive days. Placebo capsules are taken orally and contain maltodextrin.",[198],[217],{"name":218,"affiliation":219,"role":220},"Jette Frederiksen, Prof, MD","Copenhagen University Hospital, Rigshospitalet-Glostrup","PRINCIPAL_INVESTIGATOR",[222],{"name":223,"role":224,"phone":225,"phoneExt":185,"email":226},"Moschoula Passali, MSc, PhD","CONTACT","+45 38633467","moschoula.passali@regionh.dk",[228],{"facility":229,"status":230,"city":231,"state":185,"zip":232,"country":233,"countryCode":234,"cosmosGeoPoint":235,"geoPoint":240,"contacts":241},"Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup","RECRUITING","Glostrup Municipality","2600","Denmark","DK",{"type":236,"coordinates":237},"Point",[238,239],12.40377,55.6666,{"lat":239,"lon":238},[242,246],{"name":243,"role":224,"phone":244,"phoneExt":185,"email":245},"Jette Lautrup Frederiksen, Prof, MD","+4538633041","jette.lautrup.battistini@regionh.dk",{"name":243,"role":220,"phone":185,"phoneExt":185,"email":185},{"type":220,"investigatorFullName":248,"investigatorTitle":249,"investigatorAffiliation":5,"oldNameTitle":185,"oldOrganization":185},"Jette Lautrup Frederiksen","Prof, DMSc, MD",[251,253],{"name":252,"class":6},"University of Copenhagen",{"name":254,"class":6},"University of Southampton","100601055",false,"NCT07105514","Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2","Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2 (iPROACT-pilot2)","iPROACT-pilot2","Inclusion Criteria:\n\n* Healthy women and men ≥18 and ≤65 years of age\n* Deemed mentally and physically able to participate\n\nExclusion Criteria:\n\n* Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders\n* Use of antibiotics within the last month\n* Pregnancy, lactation or childbirth within the last five months\n* Use of prescription medication",true,"ALL","18 Years","65 Years",{"count":267,"type":268},32,"ESTIMATED","INTERVENTIONAL",[271],"NA","The goal of this trial is to investigate the biological effects of oral supplementation with indole-3-propionic acid (IPA) taken twice daily in healthy adults. The main scientific questions are:\n\n* Does supplementation with IPA increase the abundance of regulatory T cells in the blood? Regulatory T cells are believed to play an important role in preventing autoimmune diseases.\n* 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.\n* Does supplementation with IPA affect blood analyses commonly performed to assess the risk of metabolic disorders like type 2 diabetes and cardiovascular diseases?\n\nParticipants will:\n\n* Take capsules to achieve a total daily dose of 1000 mg of IPA or placebo: 500 mg every morning and 500 mg every evening for 14 days.\n* Visit the clinic at the beginning (day 1) and at the end (day 15) of the supplementation period to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.",[274],"Healthy",[276,277,278,279,280],"indole-3-propionic acid","gut bacterial metabolite","regulatory T cells","brain-derived neurotrophic factor","dietary supplement","2025-08-07",{"date":283,"type":284},"2025-08-08","ACTUAL",{"date":286,"type":284},"2025-08-04",{"date":288,"type":268},"2026-06-30",{"name":5,"class":6},1]