Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 7:58 AM
Study NCT ID:
NCT05190432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taxifolin/ergothioneine and Immune Biomarkers in Healthy Volunteers (TaxEr)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}, {'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003377', 'term': 'taxifolin'}, {'id': 'D004880', 'term': 'Ergothioneine'}], 'ancestors': [{'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006639', 'term': 'Histidine'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Alphabetically labelled treatments, with de-blinding envelope held by an independent researcher at the University of Southampton.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A n=90 study (3 treatment arms, each n=30) providing participants with either 250mg/day Taxifolin/DHQ, 80mg/day Ergothioneine, or control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2021-12-28', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phagocytosis activity by granulocytes ex vivo', 'timeFrame': '8 weeks post intervention', 'description': 'Mean fluorescence intensity per cell will be assessed by flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Percentage phagocytosis by monocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.'}, {'measure': 'Phagocytosis activity by monocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Mean fluorescence intensity per cell will be assessed by flow cytometry.'}, {'measure': 'Percentage phagocytosis by granulocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.'}, {'measure': 'Phagocytosis activity by granulocytes ex vivo', 'timeFrame': '4 weeks, 3 months post intervention', 'description': 'Mean fluorescence intensity per cell will be assessed by flow cytometry.'}, {'measure': 'Percentage oxidative burst by monocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.'}, {'measure': 'Oxidative burst activity by monocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Mean fluorescence intensity per cell will be assessed by flow cytometry.'}, {'measure': 'Percentage oxidative burst by granulocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.'}, {'measure': 'Oxidative burst activity by granulocytes ex vivo', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Mean fluorescence intensity per cell will be assessed by flow cytometry.'}, {'measure': 'Frequencies of naive T cells', 'timeFrame': '8 weeks', 'description': 'The proportion of naive T cells will be assessed by flow cytometry.'}, {'measure': 'Frequencies of memory T cells', 'timeFrame': '8 weeks', 'description': 'The proportion of memory T cells will be assessed by flow cytometry.'}, {'measure': 'CD57 expression upon T cells.', 'timeFrame': '8 weeks', 'description': 'The proportion of T cells expressing CD57 (a marker associated with chronic immune activation) and the mean fluorescence intensity per cell will be assessed by flow cytometry.'}, {'measure': 'CD28 expression upon T cells.', 'timeFrame': '8 weeks', 'description': 'The proportion of T cells expressing CD28 (a cell surface marker required for T cell activation and survival) and the mean fluorescence intensity per cell will be assessed by flow cytometry.'}, {'measure': 'Plasma lipid peroxides', 'timeFrame': '8 weeks', 'description': 'Participant plasma lipid peroxides will be measured by colorimetric analysis.'}, {'measure': 'Urinary isoprostanes', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Participant urinary isoprostanes will be measured by commercially available ELISA.'}, {'measure': 'Plasma isoprostanes', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Participant plasma isoprostanes will be measured by commercially available ELISA.'}, {'measure': 'Cytokine production by cryopreserved peripheral blood mononuclear cells in response to lipopolyssaccharide', 'timeFrame': '4 weeks, 8 weeks', 'description': 'A panel of pro- and anti-inflammatory cytokines secreted by immune cells ex vivo will be assessed by Luminex array.'}, {'measure': 'Cytokine production by cryopreserved peripheral blood mononuclear cells in response to influenza or coronavirus vaccine products', 'timeFrame': '4 weeks, 8 weeks', 'description': 'A panel of pro- and anti-inflammatory cytokines secreted by immune cells ex vivo will be assessed by Luminex array.'}, {'measure': 'Metabolomic analysis of urine samples', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Full metabolic profiling of first-morning urine samples will be used to assess changes to metabolic activity of participants and their microbiome.'}, {'measure': 'Metabolomic analysis of serum samples', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Full metabolic profiling of serum samples will be used to assess changes to metabolic activity of participants.'}, {'measure': 'Faecal microbiome analysis', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'Sequences of ribosomal RNA (rRNA) in participant faecal samples will be measured to assess changes in the numbers or proportions of bacterial genera and species/strains.'}, {'measure': 'Incidence of self-reported seasonal cold, coronavirus and influenza-like illness.', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'A daily online form will be completed by participants to log any seasonal cold, coronavirus and influenza-like illness.'}, {'measure': 'Duration of self-reported illness.', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'A daily online form will be completed by participants to log any self-reported illness.'}, {'measure': 'Severity of self-reported illness.', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'A daily online form will be completed by participants to log any self-reported illness.'}, {'measure': 'Self-reported medication use.', 'timeFrame': '4 weeks, 8 weeks, 3 months post intervention', 'description': 'A daily online form will be completed by participants to log any medication use.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phagocytosis', 'Immunosenecence', 'Cytokine', 'Antioxidant', 'Metabolome', 'Microbiome'], 'conditions': ['Antioxidative Stress', 'Cold', 'Influenza', 'Aging', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '23902657', 'type': 'BACKGROUND', 'citation': 'Albers R, Bourdet-Sicard R, Braun D, Calder PC, Herz U, Lambert C, Lenoir-Wijnkoop I, Meheust A, Ouwehand A, Phothirath P, Sako T, Salminen S, Siemensma A, van Loveren H, Sack U. Monitoring immune modulation by nutrition in the general population: identifying and substantiating effects on human health. Br J Nutr. 2013 Aug;110 Suppl 2:S1-30. doi: 10.1017/S0007114513001505.'}, {'type': 'BACKGROUND', 'citation': 'Childs, C. E., & Calder, P. C. (2017). Modifying the gut microbiome through diet: effects on the immune system of elderly subjects. In T. Fulop, C. Franceschi, K. Hirokawa, & G. Pawelec (Eds.), Handbook of Immunosenescence Cham: Springer International Publishing AG. DOI: 10.1007/978-3-319-64597-1_160-1'}, {'pmid': '32625400', 'type': 'BACKGROUND', 'citation': 'EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle HJ, Naska A, Neuhauser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjodin A, Stern M, Tome D, Vinceti M, Willatts P, Engel KH, Marchelli R, Poting A, Poulsen M, Schlatter J, Gelbmann W, Van Loveren H. Scientific Opinion on taxifolin-rich extract from Dahurian Larch (Larix gmelinii). EFSA J. 2017 Feb 14;15(2):e04682. doi: 10.2903/j.efsa.2017.4682. eCollection 2017 Feb.'}, {'pmid': '32625352', 'type': 'BACKGROUND', 'citation': 'EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S, Heinonen M, Hirsch-Ernst KI, Mangelsdorf I, McArdle HJ, Naska A, Neuhauser-Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjodin A, Stern M, Tome D, Vinceti M, Willatts P, Engel KH, Marchelli R, Poting A, Poulsen M, Schlatter JR, Ackerl R, van Loveren H. Statement on the safety of synthetic l-ergothioneine as a novel food - supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women. EFSA J. 2017 Nov 13;15(11):e05060. doi: 10.2903/j.efsa.2017.5060. eCollection 2017 Nov.'}, {'pmid': '19267323', 'type': 'BACKGROUND', 'citation': 'Vega-Villa KR, Remsberg CM, Ohgami Y, Yanez JA, Takemoto JK, Andrews PK, Davies NM. Stereospecific high-performance liquid chromatography of taxifolin, applications in pharmacokinetics, and determination in tu fu ling (Rhizoma smilacis glabrae) and apple (Malus x domestica). Biomed Chromatogr. 2009 Jun;23(6):638-46. doi: 10.1002/bmc.1165.'}, {'pmid': '17616140', 'type': 'BACKGROUND', 'citation': 'Ey J, Schomig E, Taubert D. Dietary sources and antioxidant effects of ergothioneine. J Agric Food Chem. 2007 Aug 8;55(16):6466-74. doi: 10.1021/jf071328f. Epub 2007 Jul 6.'}, {'pmid': '26985232', 'type': 'BACKGROUND', 'citation': 'Przemska-Kosicka A, Childs CE, Enani S, Maidens C, Dong H, Dayel IB, Tuohy K, Todd S, Gosney MA, Yaqoob P. Effect of a synbiotic on the response to seasonal influenza vaccination is strongly influenced by degree of immunosenescence. Immun Ageing. 2016 Mar 15;13:6. doi: 10.1186/s12979-016-0061-4. eCollection 2016.'}, {'pmid': '2267325', 'type': 'BACKGROUND', 'citation': 'Ohara O. [Rapid cDNA sequencing method using the polymerase chain reaction]. Tanpakushitsu Kakusan Koso. 1990 Oct;35(14):2319-28. No abstract available. Japanese.'}, {'pmid': '4597226', 'type': 'BACKGROUND', 'citation': 'Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The complexities of the immune system make measuring the impact of dietary interventions upon its function challenging. The immune system is highly responsive to environmental influences, including the diet. An individual's diet provides the energy required to mount a strong and protective immune response, the building blocks required for synthesis of immune mediators such as antibodies and cytokines, and can also indirectly affect immune function via changes in the gut microbiome. Immune function varies across the lifecourse, with a well understood decline in immune function with age, resulting in impaired vaccination responses and an increased risk of infections and of severe complications and mortality arising from common communicable diseases such as influenza. This impaired immunity with ageing is known as immunosenescence and this affects both innate and acquired arms of the immune system.", 'detailedDescription': 'Expert guidance is available to inform the design of human nutrition trials to ensure they include the most relevant immunological outcomes (Albers, 2013). In this study, ex vivo phagocytosis and oxidative burst of immune cells will be the primary outcome, supported by other ex vivo immune measures of high clinical relevance including functional assessment of cytokine production and expression of activation markers.\n\nHuman nutritional trials frequently omit to monitor the degree of immunosenescence in participants, even amongst studies conducted amongst older adults. For example, a recent review of pre- and probiotic trials which assessed immune responses in older adults identified that only two of thirty-six studies assessed any marker of immunosenescence (Childs \\& Calder, 2017).\n\nTaxifolin/DHQ is a naturally occurring polyphenol found in apples, onions and other fruits and bark extracts. Ergothioneine is an amino acid found in mushrooms, oats and some bean varieties. We hypothesise that Taxifolin/DHQ and/or Ergothioneine will alter immune function via their established antioxidant effects, and that the effects observed will vary between older adults relative to their degree of immunosenescence.\n\nThough current dietary guidelines advise consumption of 5 portions of fruits and vegetables per day, recent surveys reveal that fewer than 30% of adults achieve this. Antioxidants found within fruits and vegetables are understood to be one of the important aspects by which our diet can influence health. It is important to investigate the effects of such antioxidants through well designed and conducted human trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 50-65yr\n* BMI 18.5-30kg/m2\n* Willing to avoid consumption of foods rich in Taxifolin/DHQ and Ergothioneine during the study period\n* Willing to avoid taking any other food supplements or high doses of vitamins during the study period\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Use of prescription medication which may influence immune function, such as anti-inflammatory or immunosuppressant medication\n* Diabetes requiring any medication\n* Liver cirrhosis\n* A history of drug or alcohol misuse\n* Asplenia or other acquired or congenital immunodeficiencies\n* Any autoimmune disease including connective tissue diseases\n* Malignancy\n* Laboratory confirmed SARS-CoV-2 infection within last 3 months\n* self-reported symptoms of acute or recent infection (including use of antibiotics within the last 3 months)'}, 'identificationModule': {'nctId': 'NCT05190432', 'acronym': 'TaxEr', 'briefTitle': 'Taxifolin/ergothioneine and Immune Biomarkers in Healthy Volunteers (TaxEr)', 'organization': {'class': 'OTHER', 'fullName': 'University of Southampton'}, 'officialTitle': 'A Pilot Study of Dietary Taxifolin/Dihydroquercetin and Ergothioneine and Immune Biomarkers in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ERGO61222.A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taxifolin/Dihydroquercetin', 'description': '250mg/day Taxifolin (also known as Dihydroquercetin). One capsule in the morning for 8 weeks.', 'interventionNames': ['Dietary Supplement: Taxifolin']}, {'type': 'EXPERIMENTAL', 'label': 'Ergothioneine', 'description': '80mg/day Ergothioneine. One capsule in the morning for 8 weeks.', 'interventionNames': ['Dietary Supplement: Ergothioneine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'One capsule in the morning for 8 weeks.', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Taxifolin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dihydroquercetin'], 'description': 'A naturally occurring polyphenol found in apples, onions and other fruits and bark extracts.', 'armGroupLabels': ['Taxifolin/Dihydroquercetin']}, {'name': 'Ergothioneine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'An amino acid found in mushrooms, oats and some bean varieties.', 'armGroupLabels': ['Ergothioneine']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Microcrystalline cellulose.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'NIHR Southampton Biomedical Research Centre', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Caroline E Childs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southampton'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southampton', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue California', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}