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

Phase 3

Completed

• Conditions: Adherence, Patient
• Interventions: Drug: Immulina

• Registration Number: NCT05556967
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2023-08-09
• Primary Completion: 2023-10-19
• Study Completion: 2023-10-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
palmitoleic acid, ug/mL	Over 7 hour period	Differences in palmitoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
steric acid, ug/mL	Over 7 hour period	Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
gamma-linolenic acid (GLA), ug/mL	Over 7 hour period	Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
5'-methylsulfinyladenosine (MSA), ug/mL	Over 7 hour period	Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
linoleic acid, ug/mL	Over 7 hour period	Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
Sulfoquinovose (SQ), ug/mL	Over 7 hour period	Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
palmitic acid, ug/mL	Over 7 hour period	Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
oleic acid, ug/mL	Over 7 hour period	Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina

Trial Locations

Locations (1)

Clinical Research and Trials Unit - University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States