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

NCT05190432 | Active Not Recruiting

• 1 other identifier: ERGO61222.A1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antioxidative Stress; Cold; Influenza; Aging; Inflammation

Keywords

Phagocytosis; Immunosenecence; Cytokine; Antioxidant; Metabolome; Microbiome

Outcome Measures

Primary Outcomes (1)

• Phagocytosis activity by granulocytes ex vivo

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

  8 weeks post intervention

Secondary Outcomes (24)

• Percentage phagocytosis by monocytes ex vivo

  4 weeks, 8 weeks, 3 months post intervention

• Phagocytosis activity by monocytes ex vivo

  4 weeks, 8 weeks, 3 months post intervention

• Percentage phagocytosis by granulocytes ex vivo

  4 weeks, 8 weeks, 3 months post intervention

• Phagocytosis activity by granulocytes ex vivo

  4 weeks, 3 months post intervention

• Percentage oxidative burst by monocytes ex vivo

  4 weeks, 8 weeks, 3 months post intervention

Study Arms (3)

Taxifolin/Dihydroquercetin

EXPERIMENTAL

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

Dietary Supplement: Taxifolin

Ergothioneine

EXPERIMENTAL

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

Dietary Supplement: Ergothioneine

Control

PLACEBO COMPARATOR

One capsule in the morning for 8 weeks.

Dietary Supplement: Control

Interventions

Taxifolin DIETARY_SUPPLEMENT

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

Also known as: Dihydroquercetin

Taxifolin/Dihydroquercetin

Ergothioneine DIETARY_SUPPLEMENT

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

Ergothioneine

Control DIETARY_SUPPLEMENT

Microcrystalline cellulose.

Control

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Southampton: lead
• Blue California: collaborator

Study Sites (1)

NIHR Southampton Biomedical Research Centre

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 23902657 BACKGROUND

• 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

  BACKGROUND

• 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: 32625400 BACKGROUND

• 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: 32625352 BACKGROUND

• 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: 19267323 BACKGROUND

• 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: 17616140 BACKGROUND

• 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: 26985232 BACKGROUND

• 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: 2267325 BACKGROUND

• 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.

  PMID: 4597226 BACKGROUND

MeSH Terms

Conditions

Common Cold; Influenza, Human; Inflammation

Interventions

taxifolin; Ergothioneine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Histidine; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Caroline E Childs, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Alphabetically labelled treatments, with de-blinding envelope held by an independent researcher at the University of Southampton.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A n=90 study (3 treatment arms, each n=30) providing participants with either 250mg/day Taxifolin/DHQ, 80mg/day Ergothioneine, or control.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 13, 2022
• Study Start: November 10, 2021
• Primary Completion: September 29, 2022
• Study Completion: July 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)