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Clinical Trials/NCT01784692
NCT01784692
Completed
Not Applicable

Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

University of Mississippi Medical Center1 site in 1 country21 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly Immune Senescence
Sponsor
University of Mississippi Medical Center
Enrollment
21
Locations
1
Primary Endpoint
Interferon gamma (IFNg)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
September 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gailen D. Marshall

Professor of Medicine and Pediatrics, Vice Chair for Research, Department of Medicine, Director, Division of Clinical Immunology and Allergy, Chief, Laboratory of Behavioral Immunology Research

University of Mississippi Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Interferon gamma (IFNg)

Time Frame: 8 weeks

Increase in IFNg from baseline to 8 weeks

Secondary Outcomes

  • Psychological Measures(8 weeks)
  • Optimal supplement regime(8 weeks)
  • Demographic differences(8 weeks)
  • Immune biomarkers(8 weeks)

Study Sites (1)

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