CompletedPhase 3

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

United States20 participantsStarted 2023-08-09

Plain-language 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).

Who can participate

Age range18 Years – 50 Years

SexALL

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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

What they're measuring

gamma-linolenic acid (GLA), ug/mL

Timeframe: Over 7 hour period

Sulfoquinovose (SQ), ug/mL

Timeframe: Over 7 hour period

5'-methylsulfinyladenosine (MSA), ug/mL

Timeframe: Over 7 hour period

palmitic acid, ug/mL

Timeframe: Over 7 hour period

linoleic acid, ug/mL

Timeframe: Over 7 hour period

palmitoleic acid, ug/mL

Timeframe: Over 7 hour period

steric acid, ug/mL

Timeframe: Over 7 hour period

oleic acid, ug/mL

Timeframe: Over 7 hour period

Trial details

NCT IDNCT05556967

SponsorUniversity of Mississippi Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-19

View on ClinicalTrials.gov More Adherence, Patient trials