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

Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM 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).

Study Overview

• Status: Completed
• Conditions: Adherence, Patient
• Intervention / Treatment: Drug: Immulina

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Clinical Research and Trials Unit - University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immulina Dietary Supplementation; Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day.	Drug: Immulina; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Gailen D Marshall, Jr., MD, PhD, University of Mississippi Medical Center

Publications and helpful links

General Publications

• Wu D, Meydani M, Leka LS, Nightingale Z, Handelman GJ, Blumberg JB, Meydani SN. Effect of dietary supplementation with black currant seed oil on the immune response of healthy elderly subjects. Am J Clin Nutr. 1999 Oct;70(4):536-43. doi: 10.1093/ajcn/70.4.536.
• Tahvonen RL, Schwab US, Linderborg KM, Mykkanen HM, Kallio HP. Black currant seed oil and fish oil supplements differ in their effects on fatty acid profiles of plasma lipids, and concentrations of serum total and lipoprotein lipids, plasma glucose and insulin. J Nutr Biochem. 2005 Jun;16(6):353-9. doi: 10.1016/j.jnutbio.2005.01.004.
• Geppert J, Demmelmair H, Hornstra G, Koletzko B. Co-supplementation of healthy women with fish oil and evening primrose oil increases plasma docosahexaenoic acid, gamma-linolenic acid and dihomo-gamma-linolenic acid levels without reducing arachidonic acid concentrations. Br J Nutr. 2008 Feb;99(2):360-9. doi: 10.1017/S0007114507801577. Epub 2007 Aug 3.
• Martens-Lobenhoffer J, Meyer FP. Pharmacokinetic data of gamma-linolenic acid in healthy volunteers after the administration of evening primrose oil (Epogam). Int J Clin Pharmacol Ther. 1998 Jul;36(7):363-6.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Participants; Natural Dietary Supplement; Immulina TM
• Other Study ID Numbers: 2022-363; 1U19AT010838-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No