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Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

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ClinicalTrials.gov Identifier: NCT01784692
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Gailen D. Marshall, University of Mississippi Medical Center

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

Condition or disease Intervention/treatment Phase
Elderly Immune Senescence Dietary Supplement: Immulina Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Placebo Comparator: Placebo
10 participants will be randomized to take 1 capsule of placebo daily.
Dietary Supplement: Immulina
Other Name: Spirulina

Experimental: Immulina 200 mg/day
10 participants will be randomized to take 200 mg/day of Immulina.
Dietary Supplement: Immulina
Other Name: Spirulina

Experimental: Immulina 400 mg/day
10 participants will be randomized to take 400 mg/day of Immulina.
Dietary Supplement: Immulina
Other Name: Spirulina

Experimental: Immulina 800 mg/day
10 participants will be randomized to take 800 mg/day of Immulina.
Dietary Supplement: Immulina
Other Name: Spirulina




Primary Outcome Measures :
  1. Interferon gamma (IFNg) [ Time Frame: 8 weeks ]
    Increase in IFNg from baseline to 8 weeks


Secondary Outcome Measures :
  1. Psychological Measures [ Time Frame: 8 weeks ]
    Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry

  2. 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

  3. Demographic differences [ Time Frame: 8 weeks ]
    Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status

  4. 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784692


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: Gailen D. Marshall, Jr., MD, PhD University of Mississippi Medical Center

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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT01784692     History of Changes
Other Study ID Numbers: 2012-0255
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016

Keywords provided by Gailen D. Marshall, University of Mississippi Medical Center:
Immulina
Elderly
Immune