ClinicalTrials.gg
Active, not recruitingNCT05190432TaxErUpdated May 13, 2026

Taxifolin/Ergothioneine and Immune Biomarkers in Healthy Volunteers (TaxEr)

An interventional study of Taxifolin and Ergothioneine in Antioxidative Stress, Cold and Influenza, sponsored by University of Southampton. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 50 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by University of Southampton · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Antioxidative Stress
  • Cold
  • Influenza
  • Aging
  • Inflammation

Keywords

  • Phagocytosis
  • Immunosenecence
  • Cytokine
  • Antioxidant
  • Metabolome
  • Microbiome
03

In context

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

This study's enrollment of 90 is below the median of 150 across 184 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

University of Southampton is the lead sponsor of 122 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 50-65yr
  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Use of prescription medication which may influence immune function, such as anti-inflammatory or medication
  • Diabetes requiring any medication
  • Liver cirrhosis
  • A history of drug or alcohol misuse
  • Asplenia or other acquired or congenital immunodeficiencies
  • Any disease including connective tissue diseases
  • 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)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Taxifolin/Dihydroquercetin

    250mg/day Taxifolin (also known as Dihydroquercetin). One capsule in the morning for 8 weeks.

    Dietary Supplement: Taxifolin

  • Experimental
    Ergothioneine

    80mg/day Ergothioneine. One capsule in the morning for 8 weeks.

    Dietary Supplement: Ergothioneine

  • Placebo comparator
    Control

    One capsule in the morning for 8 weeks.

    Dietary Supplement: Control

Interventions

  • Dietary supplementTaxifolin

    A naturally occurring polyphenol found in apples, onions and other fruits and bark extracts.

    Also known as: Dihydroquercetin

  • Dietary supplementErgothioneine

    An amino acid found in mushrooms, oats and some bean varieties.

  • Dietary supplementControl

    Microcrystalline cellulose.

06

What researchers measure

Primary outcomes

  1. Phagocytosis activity by granulocytes ex vivo

    Mean fluorescence intensity per cell will be assessed by flow cytometry.

    Time frame: 8 weeks post intervention

Secondary outcomes

  1. Percentage phagocytosis by monocytes ex vivo

    Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  2. Phagocytosis activity by monocytes ex vivo

    Mean fluorescence intensity per cell will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  3. Percentage phagocytosis by granulocytes ex vivo

    Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  4. Phagocytosis activity by granulocytes ex vivo

    Mean fluorescence intensity per cell will be assessed by flow cytometry.

    Time frame: 4 weeks, 3 months post intervention

  5. Percentage oxidative burst by monocytes ex vivo

    Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  6. Oxidative burst activity by monocytes ex vivo

    Mean fluorescence intensity per cell will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  7. Percentage oxidative burst by granulocytes ex vivo

    Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  8. Oxidative burst activity by granulocytes ex vivo

    Mean fluorescence intensity per cell will be assessed by flow cytometry.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  9. Frequencies of naive T cells

    The proportion of naive T cells will be assessed by flow cytometry.

    Time frame: 8 weeks

  10. Frequencies of memory T cells

    The proportion of memory T cells will be assessed by flow cytometry.

    Time frame: 8 weeks

  11. 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.

    Time frame: 8 weeks

  12. 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.

    Time frame: 8 weeks

  13. Plasma lipid peroxides

    Participant plasma lipid peroxides will be measured by colorimetric analysis.

    Time frame: 8 weeks

  14. Urinary isoprostanes

    Participant urinary isoprostanes will be measured by commercially available ELISA.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  15. Plasma isoprostanes

    Participant plasma isoprostanes will be measured by commercially available ELISA.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  16. 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.

    Time frame: 4 weeks, 8 weeks

  17. 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.

    Time frame: 4 weeks, 8 weeks

  18. 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.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  19. Metabolomic analysis of serum samples

    Full metabolic profiling of serum samples will be used to assess changes to metabolic activity of participants.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  20. 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.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  21. 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.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  22. Duration of self-reported illness.

    A daily online form will be completed by participants to log any self-reported illness.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  23. Severity of self-reported illness.

    A daily online form will be completed by participants to log any self-reported illness.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

  24. Self-reported medication use.

    A daily online form will be completed by participants to log any medication use.

    Time frame: 4 weeks, 8 weeks, 3 months post intervention

07

Study locations

1 site
  • NIHR Southampton Biomedical Research Centre
    Southampton, Hampshire SO16 6YD, United Kingdom
08

References and documents

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 23902657 ↗
  • 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
  • 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 32625400 ↗
  • 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. PubMed 32625352 ↗
  • 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. PubMed 19267323 ↗
  • 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. PubMed 17616140 ↗
  • 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. PubMed 26985232 ↗
  • Kang 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 18345348 ↗
  • 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. PubMed 4597226 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Sep 2022, 10 months.

Of 49 interventional studies with no phase under Common Cold, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's 10 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2020
First posted
Jan 13, 2022
StartActual
Nov 10, 2021
Primary completionActual
Sep 29, 2022
CompletionEst.
Jul 2026
Last update
May 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05190432
Collaborators
Blue California
Responsible party
Sponsor
First posted
Jan 13, 2022
Start date
Nov 10, 2021
Primary completion
Sep 29, 2022
Completion
Jul 2026 (estimated)
Last update
May 13, 2026

Study contacts

Caroline E Childs, PhD
principal investigator · University of Southampton

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ergothioneine

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