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Immunosenescence clinical trials

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NCT ID: NCT05920148 Recruiting - Aging Clinical Trials

The Immu-KNEE-ty Study

Start date: January 12, 2024
Phase:
Study type: Observational

The goal of this observational study is to determine changes in immune functioning after total knee replacement surgery in elderly. The study population consists of 14 patients aged 65 years or over undergoing primary total knee replacement surgery. Immune functioning will be assessed at multiple timepoints before and after surgery (i.e., ± 6 weeks before, and 1 day, 1 week, ± 2 weeks, and ± 6 weeks after surgery). Each patient will serve as his/her own control. Immune functioning will primarily be assessed by determining the change from baseline in monocyte-derived TNFα production at 1 week after surgery. Changes in monocyte responsiveness are considered indicative for changes in immune functioning. As secondary objective, additional parameters of immune functioning will be assessed. In addition, the course of immune functioning following total knee replacement surgery will be investigated. Burden and potential risks for the patient are estimated to be minor. During the study, 5 blood samples of 20 mL will be collected over a period of ± 12 weeks, resulting in a total blood draw of 100 mL. During surgery a sample of synovial fluid (± 2 mL) will be taken from surgical waste. Before and after surgery patients will report their pain medication intake and the presence of cold and flu-like symptoms in a diary. Patients do not directly benefit from the study.

NCT ID: NCT05322343 Recruiting - Depression Clinical Trials

Biobank and Brain Health in Bordeaux.

B-cube
Start date: March 22, 2022
Phase:
Study type: Observational [Patient Registry]

B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.

NCT ID: NCT04563650 Active, not recruiting - Covid19 Clinical Trials

COVID-19 Serology and Immunosenescence

SERO-CoV-OLD
Start date: September 18, 2020
Phase: N/A
Study type: Interventional

This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors. This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.

NCT ID: NCT04542330 Completed - Covid19 Clinical Trials

Using BCG to Protect Senior Citizens During the COVID-19 Pandemic

Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

Background: The virus SARS-CoV-2 has spread rapidly throughout the world. Seniors are at high risk of severe COVID-19 when infected. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified: "trained innate immunity". The investigators hypothesize that BCG vaccination can reduce the risk of COVID-19 and other infections among senior citizens during the COVID-19 pandemic. Objectives: Primary objective: To reduce senior citizens' risk of acute infection during the COVID-19 pandemic. Secondary objectives: To reduce senior citizens' risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens' risk of self-reported respiratory illness during the COVID-19 pandemic. Study design: A placebo-controlled randomized trial. Study population: 1900 seniors 65 years of age or above. Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline). Outcomes: Primary outcome: "Acute infection" identified either by a doctor, antibiotics use, hospitalization, or death due to infection. Secondary outcomes: Verified SARS-CoV-2 infection and self-reported respiratory illness. With an expected incidence of "acute infection" of 20%, the trial can show a 25% risk reduction in the the intervention group versus the placebo group by including a total of 1900 individuals, 950 individuals in each group. Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. If BCG can reduce the risk of acute infection in seniors by 25% it has tremendous public health importance, both during the COVID-19 pandemic and overall.

NCT ID: NCT04375657 Recruiting - Immunosenescence Clinical Trials

Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

TRIIM-X
Start date: November 23, 2020
Phase: Phase 2
Study type: Interventional

The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally. The study will evaluate biomarkers for epigenetic aging and immunosenescence, as well as evaluate established clinical measures and risk factors for prevention of physical frailty, cancer, cardiovascular disease, diabetes, dementia, and also infectious diseases, including flu and COVID-19. The study uses multiple agents in combination with personalized doses of recombinant human growth hormone (somatropin), metformin, and DHEA, in a similar manner to how the combination treatment was applied in the earlier TRIIM trial at Stanford, which demonstrated strong statistical significance for the primary efficacy endpoints that will be evaluated in TRIIM-X. Somatropin is approved by the FDA for adult growth hormone deficiency and its use in the study is guided by prior safety data established for that use and also based on safety data available on its prior use in the TRIIM trial and in clinical practice in healthy elderly individuals. There will also be control groups that enable testing of biomarker variability and the contribution of individual medications within the combination treatment. The objective of the study is to obtain information needed for designing an effective personalized and adaptive treatment regimen for a larger and more diverse study population, and to obtain additional proof of principle for the new use of the medications and biomarkers for preventive medicine. The duration of treatment in the TRIIM-X trial will be 12 months.

NCT ID: NCT03026244 Completed - Inflammation Clinical Trials

Effect of Milk Protein and Prebiotics in Combination With Vitamin D on Innate Immunity in Elderly People

Start date: November 2016
Phase: N/A
Study type: Interventional

Rationale: The immune system in the ageing population becomes compromised with age (termed "Immunosenescence"). Therefore, elderly people have a decreased ability to respond to infection and vaccination. Furthermore, many of the health issues associated with ageing are linked to inflammation ("Inflammaging"). It has been suggested that this compromised immune function is in part due to reduced Toll-like receptor (TLR) function, which is part of the innate immune system. Milk and dairy based products have been shown to have beneficial effects on inflammation and immunity. This effect may be mediated via support of the innate immune response and promotes TLR7 signaling in in vitro assays (unpublished observation). Also prebiotics have been suggested to influence markers of innate immune function. Furthermore, TLR function has been suggested to be correlated to vitamin D status. Therefore, in the current pilot study, the potential of milk protein, prebiotics and vitamin D to support innate immune function in elderly will be investigated. Objective: Aim of the current study is to evaluate the effect of milk protein on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by prebiotics and Vitamin D will be studied. Study design: The study will be a double-blind placebo-controlled pilot study. Study population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1: Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk protein + prebiotics + Vitamin D or placebo.

NCT ID: NCT02554188 Withdrawn - Immunosenescence Clinical Trials

Fasting-mimicking Diet and Immunosenescence

Start date: May 1, 2019
Phase: Phase 2
Study type: Interventional

The objective of this study is to test a Fasting-Mimicking Diet (FMD) for its efficacy on improving immune response to flu vaccination in an older adult population (50-75 years of age).

NCT ID: NCT01935271 Completed - Sarcopenia Clinical Trials

Nutritional Supplementation and Muscle Health: A Pilot Study on Immune Function

Start date: January 2013
Phase: N/A
Study type: Interventional

The ability of older adults to improve their muscle strength through exercise training appears related to how well their immune system functions. Thus, a nutritional supplement which improves immune function could theoretically boost strength gained for older adults from exercise. The purpose of this pilot study is to determine if a nutritional supplement has any effect on immune function. Veterans (age 60-80 yrs, N=12) be randomized in a double-blind placebo-controlled fashion to consume supplement or placebo for four weeks. After two weeks of consumption, subjects will be treated with a vaccine for tetanus, diphtheria, and pertussis. Blood will be drawn from each subject before and after vaccination to determine the effects of the supplement on immune response to vaccination. Additionally, subjects will undergo blood draw and muscle biopsy before and after two weeks of supplementation to determine the effects of supplementation on other measures of immune function (e.g. cytokine and growth factor levels). This is an important issue due to the serious health consequences associated with muscle loss in older adults and the need for improved strategies for rehabilitation.

NCT ID: NCT01896154 Completed - Immunosenescence Clinical Trials

Pilot Study on Effect Size of Non-digestible Polysaccharides (NPS) on Immunity

Fib-P-2012
Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to estimate the effect size of a 5-week consumption period of different dietary non-digestible polysaccharides (NPS) on antibody response to influenza vaccination and cellular immunity of healthy volunteers (aged ≥ 50) for clarifying whether these NPS may enable enhancement of immune defence and to estimate the sample size for a confirmative trial. Furthermore the effects on faecal microbiota and its metabolites will be investigated.

NCT ID: NCT01303484 Completed - Immunosenescence Clinical Trials

The Effect of Prebiotic B-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People

PRIMES
Start date: May 2011
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people