Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06674018
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2024-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indole-3-PROpionic Acid Clinical Trials - a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-25', 'size': 388714, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-01T03:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization is performed by external party. Each capsule bottle is named with a unique number (1-96) and no other identifier. Capsule bottles have already been randomized by the external party using block randomization with random block sizes of 4 or 8. Study participants receive the next available capsule bottle 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 as well as the identity of the groups. This is a prerequisite for performance of statistical analyses, as the primary analysis is defined as the comparison between the group with the highest treatment dose and placebo.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2024-11-02', 'studyFirstSubmitQcDate': '2024-11-02', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gastrointestinal comfort', 'timeFrame': 'Gastrointestinal symptoms are assessed on day 1 and day 15.', 'description': '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.'}, {'measure': 'Gastrointestinal transit time', 'timeFrame': 'Maize is ingested five days before visit 1 and again five days before visit 2.', 'description': '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.'}, {'measure': 'Stool consistency', 'timeFrame': '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)).', 'description': '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.'}, {'measure': 'Fecal pH', 'timeFrame': '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).', 'description': 'pH of collected fecal samples'}, {'measure': 'Antibody-coating of bacteria', 'timeFrame': '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).', 'description': 'Characterization of IgA, IgG and IgM-coating of bacteria from fecal samples using bacterial flow cytometry.'}, {'measure': 'Immunoglobulin G', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (just before first supplement/placebo dosis).', 'description': 'Plasma immunoglobulin G (g/l)'}, {'measure': 'Immunoglobulin A', 'timeFrame': '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).', 'description': 'Plasma immunoglobulin A (g/l)'}, {'measure': 'Leucocyte counts', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (just before first supplement/placebo dosis).', 'description': '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/l).'}, {'measure': 'Hemoglobin', 'timeFrame': '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).', 'description': 'Hemoglobin measured in whole blood (mmol/l).'}, {'measure': 'Alanine transaminase', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Plasma alanine transaminase (ALT, U/l) as a biomarker of liver function.'}, {'measure': 'Alkaline phosphatase', 'timeFrame': '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).', 'description': 'Alkaline phosphatase (U/l) as a biomarker of liver function.'}, {'measure': 'Aspartate aminotransferase', 'timeFrame': '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).', 'description': 'Aspartate aminotransferase also known as aspartate transaminase measured in plasma (U/l) as a biomarker of liver damage.'}, {'measure': 'Bilirubin', 'timeFrame': '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).', 'description': 'Bilirubins measured in plasma (µmol/L) as a biomarker of liver function.'}, {'measure': 'Coagulation factors II + VII + X', 'timeFrame': '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).', 'description': 'Coagulation factors II + VII + X (INR: International Normalized Ratio) measured in plasma as a biomarker of liver function.'}, {'measure': 'Lactate dehydrogenase (LDH)', 'timeFrame': '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).', 'description': 'Lactate dehydrogenase measured in plasma (U/l).'}, {'measure': 'Creatinine', 'timeFrame': '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)', 'description': 'Plasma creatinine (µmol/L) as a biomarker of kidney function.'}, {'measure': 'eGFR', 'timeFrame': '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).', 'description': 'Estimated glomerular filtration rate (eGFR/ 1,73m² (ml/min)) as a biomarker of kidney function.'}, {'measure': 'Albumin', 'timeFrame': '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).', 'description': 'Albumin measured in plasma (g/l).'}, {'measure': '25-OH-vitamin D', 'timeFrame': '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).', 'description': 'Plasma 25-OH-vitamin D (D3+D2) (nmol/L)'}, {'measure': 'Blood pressure', 'timeFrame': 'Measured on day 1 and then again on day 15', 'description': 'Blood pressure (mm Hg) defined as the lowest value obtained across three measurements.'}], 'primaryOutcomes': [{'measure': 'Regulatory T cells (first primary outcome)', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': '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.'}, {'measure': 'Brain-derived neurotrophic factor (second primary outcome)', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Brain-derived neurotrophic factor measured in plasma samples using ELISA or mesoscale.'}], 'secondaryOutcomes': [{'measure': 'Flowcytometric profiling of T cells', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': '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.\n\nTarget 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.\n\nFurthermore, Th1/Th2 and Th17/Treg ratios will be calculated and the expression of CCR7 will be analysed within the target populations.\n\nIn 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.\n\nLastly, an untargetted approach may be employed to allow for unbiased identification of changes in novel, yet uncharacterized populations.'}, {'measure': 'CRP', 'timeFrame': '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).', 'description': '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.'}, {'measure': 'Triglycerides', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Plasma triglycerides (mmol/l).'}, {'measure': 'non-HDL cholesterol', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Non-HDL cholesterol calculated as total cholesterol minus HDL cholesterol (mmol/l)'}, {'measure': 'C-peptide', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Proinsulin C-peptide (pmol/l) measured in plasma.'}, {'measure': 'Fasting glucose', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': '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.'}, {'measure': 'Isoprostane-F2-alpha', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Isoprostane-F2-alpha measured in blood or morningurine samples as a marker of lipid oxidation.'}, {'measure': '8-oxo-dG', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': "8-oxo-dG (8-Oxo-2'-deoxyguanosine) measured in blood or morningurine samples as a marker of DNA-related stress damage."}, {'measure': 'Serum metabolomics', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Total cholesterol', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Plasma cholesterol (mmol/l).'}, {'measure': 'VLDL cholesterol', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Plasma very low-density lipoproteins (mmol/l).'}, {'measure': 'LDL cholesterol', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Plasma low-density lipoprotein (LDL) (mmol/l).'}, {'measure': 'HDL cholesterol', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'Plasma high-density lipoprotein (HDL) (mmol/l).'}, {'measure': 'Malondialdehyde', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Malondialdehyde measured in blood or morningurine samples as a marker of oxidative stress.'}, {'measure': 'Protein carbonyls', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Protein carbonyls measured in blood or morningurine samples as a marker of protein oxidation.'}, {'measure': 'Glycated hemoglobin (HbA1c)', 'timeFrame': 'Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dosis).', 'description': 'HbA1c (IFCC, mmol/mol) measured in whole blood. Estimated average glucose values (mmol/l) are also calculated automatically from HbA1c by our laboratory.'}, {'measure': 'Changes in the gut microbiome', 'timeFrame': '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.', 'description': 'Characterization of the gut microbiome using molecular biology methods such as 16s rRNA sequencing.'}, {'measure': 'Characterization of the metabolic activity of the gut microbiota', 'timeFrame': '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.', 'description': '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': 'Bacterial polysaccharides', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Endotoxin, capsular polysaccharides or other bacterial polysaccharides measured in blood samples as biomarker of bacterial translocation across the intestinal epithelium.'}, {'measure': 'Pre-haptoglobin 2', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Measurement of pre-haptoglobin 2 in blood samples as a biomarker of intestinal permeability.'}, {'measure': 'Intestinal fatty acid binding protein', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Measurements of intestinal fatty acid binding protein in blood samples as a biomarker of enterocyte damage.'}, {'measure': 'Citrulline', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Measurement of citrulline in blood samples as a biomarker of intestinal function.'}, {'measure': 'Calprotectin', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Calprotectin measured in fecal samples as a biomarker of intestinal inflammation.'}, {'measure': 'Neopterin', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Neopterin measured in morningurine samples as a biomarker of systemic inflammation.'}, {'measure': 'suPAR', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Soluble urokinase plasminogen activator receptor (suPAR) measured in blood samples.'}, {'measure': 'Microvesicles', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Flow cytometric analyses of microvesicles/ microparticles in platelet-free plasma as biomarker of systemic inflammation.'}, {'measure': 'Endothelial progenitor cells', 'timeFrame': 'Results from samples taken on day 15 and adjusted for results from day 1.', 'description': 'Flow cytometric analyses of endothelial progenitor cells measured in platelet-free plasma as biomarker of systemic inflammation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indole-3-propionic acid', 'gut bacterial metabolite', 'regulatory T cells', 'brain-derived neurotrophic factor', 'dietary supplement'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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:\n\n* 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.\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* How big a dose of IPA is necessary to achieve the above benefits?\n\nParticipants will:\n\n* Take 50 mg IPA or 120 mg IPA or 500 mg IPA or placebo every morning for 14 days.\n* 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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* Pregnant or lactating women or birth within the last five months\n* Use of medicine that requires prescription'}, 'identificationModule': {'nctId': 'NCT06674018', 'acronym': 'iPROACT-pilot', 'briefTitle': 'Indole-3-PROpionic Acid Clinical Trials - a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Indole-3-PROpionic Acid Clinical Trials - a Pilot Study (iPROACT-pilot)', 'orgStudyIdInfo': {'id': 'H-24008127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '50 mg IPA', 'description': '50 mg indole-3-propionic acid', 'interventionNames': ['Dietary Supplement: Indole-3-propionic acid']}, {'type': 'EXPERIMENTAL', 'label': '120 mg IPA', 'description': '120 mg indole-3-propionic acid', 'interventionNames': ['Dietary Supplement: Indole-3-propionic acid']}, {'type': 'EXPERIMENTAL', 'label': '500 mg IPA', 'description': '500 mg indole-3-propionic acid', 'interventionNames': ['Dietary Supplement: Indole-3-propionic acid']}], 'interventions': [{'name': 'Indole-3-propionic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['120 mg IPA', '50 mg IPA', '500 mg IPA']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two capsules of placebo will be taken orally, once daily in the morning after an overnight fast for 14 consecutive days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Jette Lautrup Frederiksen, Prof, DMSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jette Lautrup Frederiksen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending 5 years following publication of the article they are presented in.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Researchers who provide a methodologically sound proposal can access the IPD to achieve the aims of the approved proposal. Proposals should be directed to jette.lautrup.battistini@regionh.dk. To gain access, data requestors will need to sign a data access agreement. Data and explanatory files will be made available at a third party website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University of Southampton', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Clinical Consultant, DMSc, MD', 'investigatorFullName': 'Jette Lautrup Frederiksen', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}