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

NCT05556967 | Completed Phase 3 FDA Drug

• 2 other identifiers: 2022-3631U19AT010838-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Adherence, Patient

Keywords

Immulina TM; Healthy Participants; Natural Dietary Supplement

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Immulina Dietary Supplementation

EXPERIMENTAL

Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day.

Drug: Immulina

Interventions

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.

Also known as: Spirulina

Immulina Dietary Supplementation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Clinical Research and Trials Unit - University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (7)

• 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.

  PMID: 10500023 BACKGROUND

• 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.

  PMID: 15936647 BACKGROUND

• 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.

  PMID: 17678567 BACKGROUND

• 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.

  PMID: 9707349 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28219973 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Interventions

Immulina

Condition Hierarchy (Ancestors)

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

Study Officials

• Gailen D Marshall, Jr., MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: August 9, 2023
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)