Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

NCT ID: NCT01784692

Last Updated: 2016-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Elderly Immune Senescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Immulina

Intervention Type DIETARY_SUPPLEMENT

Immulina 200 mg/day

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

Group Type EXPERIMENTAL

Immulina

Intervention Type DIETARY_SUPPLEMENT

Immulina 400 mg/day

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

Group Type EXPERIMENTAL

Immulina

Intervention Type DIETARY_SUPPLEMENT

Immulina 800 mg/day

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

Group Type EXPERIMENTAL

Immulina

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Immulina

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Spirulina

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gailen D. Marshall, Jr., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2012-0255

Identifier Type: -

Identifier Source: org_study_id

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