Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

University of Mississippi

Status: Completed

Conditions: Elderly Immune Senescence

Treatments: Dietary Supplement: Immulina

Study type: Interventional

Funder types: Other

Identifiers

NCT01784692

2012-0255

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

10 participants will be randomized to take 1 capsule of placebo daily.

Treatment:

Dietary Supplement: Immulina

Immulina 200 mg/day

Experimental group

Description:

10 participants will be randomized to take 200 mg/day of Immulina.

Treatment:

Dietary Supplement: Immulina

Immulina 400 mg/day

Experimental group

Description:

10 participants will be randomized to take 400 mg/day of Immulina.

Treatment:

Dietary Supplement: Immulina

Immulina 800 mg/day

Experimental group

Description:

10 participants will be randomized to take 800 mg/day of Immulina.

Treatment:

Dietary Supplement: Immulina