Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

May 24, 2016 updated by: Gailen D. Marshall, University of Mississippi Medical Center
This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
10 participants will be randomized to take 1 capsule of placebo daily.
Dietary supplement: Immulina
Other Names:
  • Spirulina
EXPERIMENTAL: Immulina 200 mg/day
10 participants will be randomized to take 200 mg/day of Immulina.
Dietary supplement: Immulina
Other Names:
  • Spirulina
EXPERIMENTAL: Immulina 400 mg/day
10 participants will be randomized to take 400 mg/day of Immulina.
Dietary supplement: Immulina
Other Names:
  • Spirulina
EXPERIMENTAL: Immulina 800 mg/day
10 participants will be randomized to take 800 mg/day of Immulina.
Dietary supplement: Immulina
Other Names:
  • Spirulina

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Gailen D. Marshall, Jr., MD, PhD, University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (ESTIMATE)

February 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-0255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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