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

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University of Mississippi

Status and phase

Completed
Phase 3

Conditions

Adherence, Patient

Treatments

Drug: Immulina

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05556967
2022-363
1U19AT010838-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Immulina Dietary Supplementation
Experimental group
Description:
Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day.
Treatment:
Drug: Immulina

Trial contacts and locations

1

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Central trial contact

Denise Montgomery, MT(ASCP); Donielle N Drakes, MBA

Data sourced from clinicaltrials.gov

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