Clinical trial NCT05556967: Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans
Official title: Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adherence, Patient
Keywords: Immulina TM
Healthy Participants
Natural Dietary Supplement
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: gamma-linolenic acid (GLA), ug/mL
timeFrame: Over 7 hour period
measure: Sulfoquinovose (SQ), ug/mL
timeFrame: Over 7 hour period
measure: 5'-methylsulfinyladenosine (MSA), ug/mL
timeFrame: Over 7 hour period
measure: palmitic acid, ug/mL
timeFrame: Over 7 hour period
measure: linoleic acid, ug/mL
timeFrame: Over 7 hour period
measure: palmitoleic acid, ug/mL
timeFrame: Over 7 hour period
measure: steric acid, ug/mL
timeFrame: Over 7 hour period
measure: oleic acid, ug/mL
timeFrame: Over 7 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Clinical Research and Trials Unit - University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Xue, C.; Hu, Y.; Saito, H.; Zhang, Z.; Li, Z.; Cai, Y.; Ou, C.; Lin, H.; Imbs, A. B. Molecular species composition of glycolipids from Sprirulina platensis. Food Chemistry 2002, 77 (1), 9-13.
citation: Goddard-Borger ED, Williams SJ. Sulfoquinovose in the biosphere: occurrence, metabolism and functions. Biochem J. 2017 Feb 20;474(5):827-849. doi: 10.1042/BCJ20160508.
citation: Mills, J. S.; Mills, G. C.; Mcadoo, D. J. Isolation and identification of 5'-methylthioadenosine sulfoxide from human urine. Nucleosides and Nucleotides 1983, 2 (5), 465-478.