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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Adherence, Patient

Intervention / Treatment
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* Dietary Supplement: Immulina


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immulina Dietary Supplementation<br>Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day. | Dietary Supplement: Immulina<br>* 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.<br>* Other names: Spirulina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gamma-linolenic acid (GLA), ug/mL | Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| Sulfoquinovose (SQ), ug/mL | Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| 5'-methylsulfinyladenosine (MSA), ug/mL | Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| palmitic acid, ug/mL | Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| linoleic acid, ug/mL | Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| palmitoleic acid, ug/mL | Differences in palmitoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| steric acid, ug/mL | Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 
| oleic acid, ug/mL | Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina | Over 7 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immulina TM, Healthy Participants, Natural Dietary Supplement