Antioxidative StressTaxErNCT05190432
Taxifolin/Ergothioneine and Immune Biomarkers in Healthy Volunteers (TaxEr)
A study testing Taxifolin and Ergothioneine in people with Antioxidative Stress and Cold, run by University of Southampton at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Antioxidative Stress, Cold, Influenza
- What is being tested?
- Taxifolin and Ergothioneine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 50-65yr
- BMI 18.5-30kg/m2
- Willing to avoid consumption of foods rich in Taxifolin/DHQ and Ergothioneine during the study period
- Willing to avoid taking any other food supplements or high doses of vitamins during the study period
- Able to provide written informed consent.
Who cannot join
- Use of prescription medication which may influence immune function, such as anti-inflammatory or immunosuppressant medication
- Diabetes requiring any medication
- Liver cirrhosis
- A history of drug or alcohol misuse
- Asplenia or other acquired or congenital immunodeficiencies
- Any autoimmune disease including connective tissue diseases
Show all 9Show fewer
- Malignancy
- Laboratory confirmed SARS-CoV-2 infection within last 3 months
- self-reported symptoms of acute or recent infection (including use of antibiotics within the last 3 months)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Southampton Biomedical Research Centre
Southampton, Hampshire, SO16 6YD
About this study
Official title: A Pilot Study of Dietary Taxifolin/Dihydroquercetin and Ergothioneine and Immune Biomarkers in Healthy Volunteers
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.
Read the detailed description
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.
Human 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).
Taxifolin/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.
Though 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.
- Conditions
- Antioxidative Stress, Cold, Influenza, Aging, Inflammation
- Being tested
- Taxifolin, Ergothioneine, Control
- Keywords
- Phagocytosis, Immunosenecence, Cytokine, Antioxidant, Metabolome, Microbiome
- Medical subject headings
- Common Cold, Influenza, Human, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxifolinDietary supplement
Also called Dihydroquercetin
A naturally occurring polyphenol found in apples, onions and other fruits and bark extracts.
ErgothioneineDietary supplement
An amino acid found in mushrooms, oats and some bean varieties.
ControlDietary supplement
Microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| Taxifolin/Dihydroquercetin | Experimental | 250mg/day Taxifolin (also known as Dihydroquercetin). One capsule in the morning for 8 weeks. Receives: Dietary Supplement: Taxifolin |
| Ergothioneine | Experimental | 80mg/day Ergothioneine. One capsule in the morning for 8 weeks. Receives: Dietary Supplement: Ergothioneine |
| Control | Placebo comparator | One capsule in the morning for 8 weeks. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phagocytosis activity by granulocytes ex vivo
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Measured: 8 weeks post intervention
Secondary outcomes (24)
Percentage phagocytosis by monocytes ex vivo
Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Phagocytosis activity by monocytes ex vivo
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Percentage phagocytosis by granulocytes ex vivo
Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Phagocytosis activity by granulocytes ex vivo
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Measured: 4 weeks, 3 months post intervention
Percentage oxidative burst by monocytes ex vivo
Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Oxidative burst activity by monocytes ex vivo
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Percentage oxidative burst by granulocytes ex vivo
Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Oxidative burst activity by granulocytes ex vivo
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Frequencies of naive T cells
The proportion of naive T cells will be assessed by flow cytometry.
Measured: 8 weeks
Frequencies of memory T cells
The proportion of memory T cells will be assessed by flow cytometry.
Measured: 8 weeks
CD57 expression upon T cells.
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.
Measured: 8 weeks
CD28 expression upon T cells.
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.
Measured: 8 weeks
Plasma lipid peroxides
Participant plasma lipid peroxides will be measured by colorimetric analysis.
Measured: 8 weeks
Urinary isoprostanes
Participant urinary isoprostanes will be measured by commercially available ELISA.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Plasma isoprostanes
Participant plasma isoprostanes will be measured by commercially available ELISA.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Cytokine production by cryopreserved peripheral blood mononuclear cells in response to lipopolyssaccharide
A panel of pro- and anti-inflammatory cytokines secreted by immune cells ex vivo will be assessed by Luminex array.
Measured: 4 weeks, 8 weeks
Cytokine production by cryopreserved peripheral blood mononuclear cells in response to influenza or coronavirus vaccine products
A panel of pro- and anti-inflammatory cytokines secreted by immune cells ex vivo will be assessed by Luminex array.
Measured: 4 weeks, 8 weeks
Metabolomic analysis of urine samples
Full metabolic profiling of first-morning urine samples will be used to assess changes to metabolic activity of participants and their microbiome.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Metabolomic analysis of serum samples
Full metabolic profiling of serum samples will be used to assess changes to metabolic activity of participants.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Faecal microbiome analysis
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.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Incidence of self-reported seasonal cold, coronavirus and influenza-like illness.
A daily online form will be completed by participants to log any seasonal cold, coronavirus and influenza-like illness.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Duration of self-reported illness.
A daily online form will be completed by participants to log any self-reported illness.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Severity of self-reported illness.
A daily online form will be completed by participants to log any self-reported illness.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Self-reported medication use.
A daily online form will be completed by participants to log any medication use.
Measured: 4 weeks, 8 weeks, 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Nov 2021
- Primary completion29 Sep 2022
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Antioxidative StressStudies 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
- Model description
- A n=90 study (3 treatment arms, each n=30) providing participants with either 250mg/day Taxifolin/DHQ, 80mg/day Ergothioneine, or control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Blue California
- Responsible party
- Sponsor
- Investigators
- Caroline E Childs, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190432
- Sponsor's protocol ID
- ERGO61222.A1
- Acronym
- TaxEr
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2020
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23902657Childs, 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
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.
PubMed 32625400EFSA 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.
PubMed 32625352Vega-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.
PubMed 19267323Ey 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.
PubMed 17616140Przemska-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.
PubMed 26985232Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.
PubMed 18345348Taves 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.
PubMed 4597226
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Dietary Taxifolin/Dihydroquercetin and Ergothioneine and Immune Biomarkers in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05190432
- Acronym / sponsor ID
- TaxEr / ERGO61222.A1
- Conditions
- Antioxidative Stress, Cold, Influenza, Aging, Inflammation
- Keywords
- Phagocytosis, Immunosenecence, Cytokine, Antioxidant, Metabolome, Microbiome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Blue California
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 Jan 2022 (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 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.
Detailed description
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.
Human 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).
Taxifolin/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.
Though 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A n=90 study (3 treatment arms, each n=30) providing participants with either 250mg/day Taxifolin/DHQ, 80mg/day Ergothioneine, or control.
| Arm | Type | Receives |
|---|---|---|
| Taxifolin/Dihydroquercetin | Experimental | Dietary Supplement: Taxifolin250mg/day Taxifolin (also known as Dihydroquercetin). One capsule in the morning for 8 weeks. |
| Ergothioneine | Experimental | Dietary Supplement: Ergothioneine80mg/day Ergothioneine. One capsule in the morning for 8 weeks. |
| Control | Placebo comparator | Dietary Supplement: ControlOne capsule in the morning for 8 weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 50-65yr
- BMI 18.5-30kg/m2
- Willing to avoid consumption of foods rich in Taxifolin/DHQ and Ergothioneine during the study period
- Willing to avoid taking any other food supplements or high doses of vitamins during the study period
- Able to provide written informed consent.
Key exclusion criteria (9 listed)
- Use of prescription medication which may influence immune function, such as anti-inflammatory or immunosuppressant medication
- Diabetes requiring any medication
- Liver cirrhosis
- A history of drug or alcohol misuse
- Asplenia or other acquired or congenital immunodeficiencies
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 |
|---|---|---|
| TaxifolinAlso: DihydroquercetinA naturally occurring polyphenol found in apples, onions and other fruits and bark extracts. | Dietary supplement | Taxifolin/Dihydroquercetin |
| ErgothioneineAn amino acid found in mushrooms, oats and some bean varieties. | Dietary supplement | Ergothioneine |
| ControlMicrocrystalline cellulose. | Dietary supplement | Control |
Primary outcome
Phagocytosis activity by granulocytes ex vivo
Time frame: 8 weeks post intervention
Mean fluorescence intensity per cell will be assessed by flow cytometry.
24 secondary outcomes
Percentage phagocytosis by monocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Phagocytosis activity by monocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Percentage phagocytosis by granulocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Phagocytosis activity by granulocytes ex vivo
Time frame: 4 weeks, 3 months post intervention
Percentage oxidative burst by monocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Oxidative burst activity by monocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Percentage oxidative burst by granulocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Oxidative burst activity by granulocytes ex vivo
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Frequencies of naive T cells
Time frame: 8 weeks
Frequencies of memory T cells
Time frame: 8 weeks
CD57 expression upon T cells.
Time frame: 8 weeks
CD28 expression upon T cells.
Time frame: 8 weeks
Plasma lipid peroxides
Time frame: 8 weeks
Urinary isoprostanes
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Plasma isoprostanes
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Cytokine production by cryopreserved peripheral blood mononuclear cells in response to lipopolyssaccharide
Time frame: 4 weeks, 8 weeks
Cytokine production by cryopreserved peripheral blood mononuclear cells in response to influenza or coronavirus vaccine products
Time frame: 4 weeks, 8 weeks
Metabolomic analysis of urine samples
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Metabolomic analysis of serum samples
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Faecal microbiome analysis
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Incidence of self-reported seasonal cold, coronavirus and influenza-like illness.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Duration of self-reported illness.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Severity of self-reported illness.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Self-reported medication use.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 23902657Albers 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.
- BackgroundChilds, 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
- Background: PubMed 32625400EFSA 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.
- Background: PubMed 32625352EFSA 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.
- Background: PubMed 19267323Vega-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.
- Background: PubMed 17616140Ey 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.
- Background: PubMed 26985232Przemska-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.
- Background: PubMed 18345348Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.
- Background: PubMed 4597226Taves 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.
- Individual participant dataSharing planned: No
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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.
Caroline E Childs, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taxifolin and Ergothioneine in people with Antioxidative Stress and Cold, run by University of Southampton at 1 site in United Kingdom.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Phagocytosis activity by granulocytes ex vivo (time frame: 8 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190432, which also lists 9 linked publications.
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 13 May 2026.