NIHR Southampton Biomedical Research Centre
Southampton, Hampshire, SO16 6YD, United Kingdom
NCT Number: NCT05190432
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.
This study is active but is not currently recruiting participants.
Notify Me50 year–65 year
All sexes
Interventional
Not applicable
Southampton, Hampshire, SO16 6YD, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A naturally occurring polyphenol found in apples, onions and other fruits and bark extracts.
Other names: Dihydroquercetin
An amino acid found in mushrooms, oats and some bean varieties.
Microcrystalline cellulose.
Time frame: 8 weeks post intervention
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Percentage of cells undergoing phagocytosis will be assessed by flow cytometry.
Time frame: 4 weeks, 3 months post intervention
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Percentage of cells undergoing oxidative burst will be assessed by flow cytometry.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Mean fluorescence intensity per cell will be assessed by flow cytometry.
Time frame: 8 weeks
The proportion of naive T cells will be assessed by flow cytometry.
Time frame: 8 weeks
The proportion of memory T cells will be assessed by flow cytometry.
Time frame: 8 weeks
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
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
Participant plasma lipid peroxides will be measured by colorimetric analysis.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Participant urinary isoprostanes will be measured by commercially available ELISA.
Time frame: 4 weeks, 8 weeks, 3 months post intervention
Participant plasma isoprostanes will be measured by commercially available ELISA.
Time frame: 4 weeks, 8 weeks
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
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, 3 months post intervention
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
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
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
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
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
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
A daily online form will be completed by participants to log any medication use.
University of Southampton
Other
A Pilot Study of Dietary Taxifolin/Dihydroquercetin and Ergothioneine and Immune Biomarkers in Healthy Volunteers
Acronym: TaxEr
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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