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Anti-inflammatory supplement to reduce immune ageing

An uncontrolled open label trial of a nutritional supplement to reduce measures of biological and immune ageing and improve physical function and quality of life in healthy older people

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77611378
Enrollment
85
Registered
2024-02-19
Start date
2022-10-01
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age related inflammation and DNA methylation Other

Interventions

This trial will test the hypothesis that a combination of vitamins and nutraceuticals (“Essentials”), all known to have an effect on immune ageing or systemic inflammation will improve both biological

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age =60 years. 2. Ability to provide informed consent. 3. Willing to stop taking multivitamins, and dietary supplements containing vitamins C and D, B3, DHA/EPA, Olive polyphenols, resveratrol and astaxanthin or food/beverage products supplemented with the above ingredients 2 weeks prior to and throughout the study. 4. Able to travel to the clinic for initial and subsequent evaluations.

Exclusion criteria

Exclusion criteria: 1. Current smokers, or ex smokers who have stopped within the last 12 months, or are using nicotine replacement products. 2. History of diabetes, myocardial infarction, congestive heart failure, kidney failure, liver disease or stroke. 3. Untreated thyroid disorder, cancer, active neoplasms. 4. Untreated gastrointestinal, or pulmonary diseases. 5. Surgery or trauma in last 60 days. 6. Inflammatory diseases, auto immune diseases or recent infection in last 60 days. 7. Allergies to any of the ingredients to be studied. 8. Currently taking or using multivitamins or dietary supplements containing vitamins C and D, B3, DHA/EPA, Olive polyphenols, resveratrol and astaxanthin or food/beverage products supplemented with the above ingredients. 9. Currently taking medication known to be metabolised by CYP3A. 10. Currently taking any of the following medications, which confound the effects of inflammation: Tamoxifen, Cyclosporine A, immunosuppressants or Anti TNF inhibitors, NSAIDs. 11. Currently taking any of the following anticoagulant drugs (blood thinners): Warfarin, Direct oral anticoagulant drugs (DOACs), and antiplatelet drugs including aspirin. 12. Individuals at risk of bleeding complications, including those with inherited bleeding disorders (such as haemophilia), or increased risk hemorrhagic stroke or events. 13. Unable or unwilling to maintain current lifestyle throughout study such as eating habits, exercise habits, etc. 14. Assessed as being frail by Fried phenotype criteria.

Design outcomes

Primary

MeasureTime frame
Immune ageing by measuring 51 different serum cytokines, chemokines and growth factors to give an iAGE score (Sayed et al 2021), hs-CRP will also be measured at baseline and 12 weeks

Secondary

MeasureTime frame
At baseline and 12 weeks we will measure 1. Biological ageing by DNA methylation in peripheral blood and saliva; 2. QoL (SF36) and diet (7 day food diary, to confirm there was no significant change in the diet of the participants) from questionnaires; 3. Physical function assessed by the SPPB (Guralink et al. 1994).

Countries

England, United Kingdom

Contacts

Public ContactThomas Jackson
t.jackson@bham.ac.uk+44 121 3713264

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026