Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

Study Overview
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Brief Summary
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This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.

Official Title
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Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

Conditions
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Elderly Immune Senescence

Intervention / Treatment
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* Dietary Supplement: Immulina


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>10 participants will be randomized to take 1 capsule of placebo daily. | Dietary Supplement: Immulina<br> <br> * Other names: Spirulina;|
| Experimental: Immulina 200 mg/day<br>10 participants will be randomized to take 200 mg/day of Immulina. | Dietary Supplement: Immulina<br> <br> * Other names: Spirulina;|
| Experimental: Immulina 400 mg/day<br>10 participants will be randomized to take 400 mg/day of Immulina. | Dietary Supplement: Immulina<br> <br> * Other names: Spirulina;|
| Experimental: Immulina 800 mg/day<br>10 participants will be randomized to take 800 mg/day of Immulina. | Dietary Supplement: Immulina<br> <br> * Other names: Spirulina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interferon gamma (IFNg) | Increase in IFNg from baseline to 8 weeks | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Measures | Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry | 8 weeks | 
| Optimal supplement regime | 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 | 8 weeks | 
| Demographic differences | Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status | 8 weeks | 
| Immune biomarkers | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immulina, Elderly, Immune