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

NCT ID: NCT05556967

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2023-10-19

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.

Conditions

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Adherence, Patient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Immulina Dietary Supplementation

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

Group Type EXPERIMENTAL

Immulina

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Spirulina

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gailen D Marshall, Jr., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

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Clinical Research and Trials Unit - University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10500023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15936647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17678567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9707349 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 28219973 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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1U19AT010838-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022-363

Identifier Type: -

Identifier Source: org_study_id

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