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Effect of Palmitoleic Acid on C-reactive Protein

NCT03625427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-12-01

No results posted yet for this study

Summary

This clinical trial will test the effects of an n-7 monounsaturated fatty acid known as palmitoleic acid (POA) on a chronic inflammation marker in overweight subjects. The study will enroll male and female subjects from healthy populations with high levels of the inflammatory marker c-reactive protein (CRP). Investigators will then determine over time if palmitoleic acid supplementation can lower circulating levels of c-reactive protein. Investigators will administer palmitoleic acid at two doses in addition to a placebo and conduct a double-blind parallel arm study. Circulating CRP will be the primary endpoint and secondary endpoints are Interleukin 6 (IL-6), Tumor necrosis factor (TNF) alpha, ghrelin, peptide tyrosine tyrosine (peptide YY), cardio lipid markers, glucose, insulin, leptin, adiponectin, and red blood cell (RBC) and serum fatty acids.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

The placebo is olive oil, stripped of polyphenols, 70% oleic acid, administered as two 1-gram capsules per day. Packaged as single-serve packets containing 2 capsules for each daily dose.

DIETARY_SUPPLEMENT

Palmitoleic acid, 500 mg (Dose 1)

Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA

DIETARY_SUPPLEMENT

Palmitoleic acid, 1,000 mg (Dose 2)

Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA

Sponsors & Collaborators

  • Organic Technologies

    collaborator UNKNOWN

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Saame R Shaikh, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2022-11-29
Completion
2022-11-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625427 on ClinicalTrials.gov