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Completed

NCT Number: NCT01784692

Pilot Study to Evaluate Immunopotentiating Effects of Immulina in Elderly Individuals

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immulina

Dietary Supplement

Other names: Spirulina

Primary outcomes

  1. Interferon gamma (IFNg)

    Time frame: 8 weeks

    Increase in IFNg from baseline to 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2013
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.