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NCT Number: NCT05556967

Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans

This is a pilot study for identifying plasma and/or urine-derived adherence/surrogate biomarker candidates for verifying Immulina™ ingestion by human volunteers (collected before and after consumption of Immulina™, a natural dietary supplement).

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Key information

Conditions

Adherence, Patient Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research and Trials Unit - University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

This pilot study is interventional, and all participants will receive one 800 mg dose of Immulina™ (four 200 mg capsules), a natural supplement, after a baseline blood and urine collection, then follow with 1 hour, 3 hour and 6 hour post-Immulina™ blood and urine collections. Samples will be sent to UM National Center for Natural Products Research (NCNPR) to analyze and compare timed blood and urine samples using gas chromatography and liquid chromatography to detect volatile and non-volatile compounds, gamma-linolenic acid (GLA), sulfoquinovose (SQ), 5'-methylsulfinyladenosine (MSA), palmitic acid, linoleic acid, palmitoleic acid and oleic acid to screen the chemical fingerprints of the human samples. The mean of the 7 biomarkers for the 4 time points will be measured and compared.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females, 18-50 years old
  • If female of childbearing potential, using acceptable means of birth control or postmenopausal for at least two years
  • Healthy

Exclusion criteria

  • pregnant or lactating females
  • significant acute disease
  • recurrent medications for chronic disease

Treatment and study plan

Immulina

Drug

Immulina is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.

Other names: Spirulina

Primary outcomes

  1. gamma-linolenic acid (GLA), ug/mL

    Time frame: Over 7 hour period

    Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  2. Sulfoquinovose (SQ), ug/mL

    Time frame: Over 7 hour period

    Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  3. 5'-methylsulfinyladenosine (MSA), ug/mL

    Time frame: Over 7 hour period

    Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  4. palmitic acid, ug/mL

    Time frame: Over 7 hour period

    Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  5. linoleic acid, ug/mL

    Time frame: Over 7 hour period

    Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  6. palmitoleic acid, ug/mL

    Time frame: Over 7 hour period

    Differences in palmitoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  7. steric acid, ug/mL

    Time frame: Over 7 hour period

    Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

  8. oleic acid, ug/mL

    Time frame: Over 7 hour period

    Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2022
Registry last updated
Jul 30, 2026

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.

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