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

Adherence, Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556967
• Other study ID #: 2022-363
• Secondary ID: 1U19AT010838-01
• Status: Completed
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: October 19, 2023

Study information

• Verified date: January 2024
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Clinical Research and Trials Unit - University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	National Center for Complementary and Integrative Health (NCCIH), University of Mississippi National Center for Natural Products Research

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View Citation

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. — View 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.

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. — View Citation

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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