NCT03625427

Effect of Palmitoleic Acid on C-reactive Protein

Completed NA Last updated 1 December 2022

What this trial tests

NA trial testing Placebo in Chronic Inflammation in 123 participants. Completed in 29 November 2022.

Timeline

26 September 2019

Primary endpoint
29 November 2022

29 November 2022

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	123
Start date	26 September 2019
Primary completion	29 November 2022
Estimated completion	29 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Placebo
• Palmitoleic acid, 500 mg (Dose 1)
• Palmitoleic acid, 1,000 mg (Dose 2)

Conditions studied

• Chronic Inflammation — all drugs for Chronic Inflammation →
• Overweight — all drugs for Overweight →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 80, any sex, with Chronic Inflammation or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Polyphenols, the Healthy Brand of Olive Oil: Insights and Perspectives.
   Finicelli M, Squillaro T, Galderisi U, Peluso G. · · 2021 · cited 36× · PMID 34836087 · DOI 10.3390/nu13113831
2. Effects of a palmitoleic acid concentrated oil on C-reactive protein levels in adults: A randomized, double-blind placebo-controlled clinical trial.
   Bridges MD, Vennam SS, Davis T, Wilcox ML, et al · · 2025 · PMID 40456315 · DOI 10.1016/j.ajcnut.2025.05.032