Elderly Immune Senescence
Conditions
Keywords
Immulina, Elderly, Immune
Brief summary
This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.
Interventions
DIETARY_SUPPLEMENTImmulina
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 60 and older; * Generally otherwise healthy for age and not taking medications/supplements that could be expected to affect stress responses and/or impact immune parameters (example - systemic steroids, beta blockers, antidepressants, anti-anxiety drugs, Echinacea supplements, ginseng supplements or Spirulina supplements).
Exclusion criteria
* Inability to comprehend and speak English; * Any history of major psychological or psychiatric illness (example - dementia, psychotic disorder, acute mania, current substance abuse) that may limit participant cooperation or compromise the integrity of self-reported clinical or psychological data; * Presence of a confounding underlying systemic illness which could interfere with immunological profiles (example - severe cardiovascular, pulmonary, hepatic, gastrointestinal, renal, neurological, musculoskeletal endocrine , or metabolic systems; other gross physical impairments; or any history of significant convulsive disorder). Specifically, patients with congestive heart failure, recent viral or bacterial illness in the past 3 weeks, chronic kidney disease, thyroid disorder, autoimmune disease will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interferon gamma (IFNg) | 8 weeks | Increase in IFNg from baseline to 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Measures | 8 weeks | Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry |
| Optimal supplement regime | 8 weeks | Optimizing Immulina dose for maximal immune biomarker levels observing changes in Treg, Tr1, Th3, T Helper1, T Helper 2 cells, salivary cortisol, salivary alpha amylase, Interleukin 4 and Interleukin 10 cytokine production from baseline to 8 weeks |
| Demographic differences | 8 weeks | Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status |
| Immune biomarkers | 8 weeks | Changes in Treg, Tr1, Th3, T Helper 1, T Helper 2 cells, salivary cortisol, salivary alpha amylase, Interleukin 4 and Interleukin 10 cytokine production from baseline to 8 weeks |
Countries
United States
Outcome results
None listed