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Trial record 1 of 1 for:    immulina University Mississippi
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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

Tracking Information
First Submitted Date  ICMJE February 4, 2013
First Posted Date  ICMJE February 6, 2013
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
Interferon gamma (IFNg) [ Time Frame: 8 weeks ]
Increase in IFNg from baseline to 8 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01784692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2013)
  • Psychological Measures [ Time Frame: 8 weeks ]
    Effects of Immulina on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry
  • 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
  • Demographic differences [ Time Frame: 8 weeks ]
    Effects of Immulina based upon demographic differences including gender, race, age, BMI and socioeconomic status
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Official Title  ICMJE Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals
Brief Summary This will be a small study aimed at determining the effects of oral Immulina consumption on the immune system in elderly individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Elderly Immune Senescence
Intervention  ICMJE Dietary Supplement: Immulina
Other Name: Spirulina
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    10 participants will be randomized to take 1 capsule of placebo daily.
    Intervention: Dietary Supplement: Immulina
  • Experimental: Immulina 200 mg/day
    10 participants will be randomized to take 200 mg/day of Immulina.
    Intervention: Dietary Supplement: Immulina
  • Experimental: Immulina 400 mg/day
    10 participants will be randomized to take 400 mg/day of Immulina.
    Intervention: Dietary Supplement: Immulina
  • Experimental: Immulina 800 mg/day
    10 participants will be randomized to take 800 mg/day of Immulina.
    Intervention: Dietary Supplement: Immulina
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2013)
40
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01784692
Other Study ID Numbers  ICMJE 2012-0255
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gailen D. Marshall, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gailen D. Marshall, Jr., MD, PhD University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP