Supplements containing the Provinal-branded purified palmitoleic acid ingredient from Ohio-based Tersus Pharmaceuticals were also associated with reductions in triglyceride and LDL cholesterol of 15%, and 8%, respectively, compared with control.
A 5% increase in HDL cholesterol was also observed following 30 days of supplementation with 220.5 mg of cis-palmitoleic acid, reported the Cleveland Clinic’s Adam Bernstein, MD, Michael Roizen, MD, and Luis Martinez, MD, in the Journal of Clinical Lipidology.
“We demonstrate that supplementation with purified palmitoleic acid in adults with dyslipidemia and systemic inflammation, 2 risk factors for cardiometabolic disease, leads to improved serum lipids and decreased inflammation,” they wrote.
“These findings build on a growing body of animal and epidemiological evidence on the potential benefits of palmitoleate.
“Thus, purified palmitoleic may be a therapeutic approach in helping maintain lipid levels within a healthy range as well as improving inflammatory markers in patients with mild dyslipidemia and inflammation.”
Drs Roizen and Martinez sit on Tersus’ scientific advisory board, and the company funded the study.
“There’s no other compound we’re aware of that could lower CRP by this much,” Lochlainn O’Haimhirgin, president of Tersus Pharmaceuticals, told us.
Provinal Purified Omega-7 is manufactured by Tersus Pharmaceuticals, based in Cleveland. The company sources its omega-7 base material from anchovy or menhaden oil.
The ingredient consists of 50% palmitoleic acid, but more importantly, it contains only a trace amount of the antagonistic palmitic acid associated with atherosclerosis, diabetes, and weight gain. The exclusion of palmitic acid is achieved through Tersus’ proprietary purification process.
The composition of the ingredient is covered by US Patent # 8,703,818, and multiple additional patents have been filed, said O’Haimhirgin.
Tersus’ palmitoleic acid ingredient is already commercially available in a number of finished product brands, including Life Extension, Metagenics, Barleans, and Swanson.
Bernstein, Roizen, and Martinez recruited 60 people with abnormal lipid levels and mild systemic inflammation, shown by slightly elevated CRP levels to participate in their randomized, double-blinded, placebo controlled trial.
Participants were randomly assigned to receive either 220.5 mg of cis-palmitoleic acid or placebo (1000 mg of medium chain triglycerides) for 30 days.
Results showed that CRP, triglyceride and LDL levels were reduced by 44%, 15%, and 8%, respectively, while HDL levels increased by an average of 5% compared with control.
“In this randomized, double-blinded, placebo controlled trial, purified palmitoleic acid exerted potent anti-inflammatory and lipid-modulating effects compared with placebo,” wrote the researchers. “Larger and longer term studies are needed to confirm these findings.”
So what next? The list of potential health benefits of palmitoleic acid is constantly expanding, said O’Haimhirgin. A recent study by scientists at Clemson University with obese sheep found that Provinal decreased weight gain, reduced fat in the muscle, and restored insulin sensitivity (Duckett et al., Diabetes Metab Syndr Obes. 2014 Vol. 20, pp. 553-63).
The company received a letter of no objection from the Food and Drug Administration for the GRAS status of the ingredient, which followed its self-affirmation of the GRAS status several years ago. The company did have an unsuccessful new dietary ingredient (NDI) notification last year, but has no plans to resubmit following its successful FDA GRAS petition, said O’Haimhirgin.
Source: Journal of Clinical Lipidology
Volume 8, Issue 6, Pages 612-617, doi: 10.1016/j.jacl.2014.08.001
“Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: A double-blinded, randomized, placebo controlled study”
Authors: A.M. Bernstein, M.F. Roizen, L. Martinez