Study Shows Purified Palmitoleic Acid (Tersus branded Omega 7 Provinal®) may be Useful in Treatment of Hypertriglyceridemia, Decreasing LDL and hs-CRP and Raising HDL.

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Report on the Study Published in October Issue of Journal of Clinical Lipidology

Tersus Pharmaceuticals, LLC

“These findings build on a growing body of in vitro, animal, and human studies, demonstrating the importance of palmitoleic acid to regulating metabolism.' - Drs. Roizen and Bernstein

The report of a study by Drs. Michael F. Roizen, MD and Adam M. Bernstein MD of the Wellness Institute of the Cleveland Clinic, “Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: A double-blinded, randomized, placebo controlled study” is featured in the online September issue of the Journal of Clinical Lipidology (http://www.lipidjournal.com/article/S1933-2874%2814%2900281-5/pdf) and the October print version.

The objective of the study was to perform the first randomized controlled trial of purified palmitoleic acid supplementation in humans. It was a 30-day parallel, double-blinded, randomized, placebo-controlled study with 60 healthy participants. The study was conducted in July 2013 by Drs. Roizen and Bernstein of the Wellness Institute of the Cleveland Clinic at the Xyrion Medical Institute, a private clinic and research center in Ponce, Puerto Rico, and approved by the Institutional Review Board of Ponce School of Medicine in Ponce. Tersus Pharmaceuticals of Cleveland, Ohio funded the study and provided capsules of their branded purified Omega 7 palmitoleic acid, Provinal™ for use in the study as well as the placebo capsules.

Adults with dyslipidemia and evidence of mild systemic inflammation (high-sensitivity C-reactive protein [hs-CRP] between 2 and 5 mg/L) were randomly allocated to receive either 220.5 mg of Provinal™ or an identical capsule with placebo (1000 mg of medium chain triglycerides, n 5 30) once per day for 30 days. Participants were asked to maintain their current diet. Serum lipids and hs-CRP were drawn at baseline and study completion (30 days).

The results of the study:

  • At 30 days, there were significant mean (95% confidence interval [CI]) reductions in CRP (21.9 [22.3 to 21.4] mg/L), triglyceride (230.2 [240.2 to 225.3] mg/dL), and low-density lipoprotein (LDL) (28.9 [212.0 to 25.8] mg/dL), and a significant increase in high-density lipoprotein (HDL) (2.4 [1.5, 3.3] mg/dL) in the intervention group compared with control.
  • These changes equated to 44%, 15%, and 8% reductions in CRP, triglyceride, and LDL respectively, and a 5% increasein HDL compared with control.

The conclusions of the study:

  • Purified palmitoleic acid exerted potent anti-inflammatory and lipid-modulating effects compared with placebo.
  • These findings build on a growing body of in vitro, animal, and human studies, demonstrating the importance of palmitoleic acid to regulating metabolism.
  • Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL.

Drs. Roizen and Bernstein submitted their report to the Journal of Clinical Lipidology on February 20, 2014 and it was accepted for publication August 6, 2014 for inclusion in the September/October issue.

“These findings build on a growing body of in vitro, animal, and human studies, demonstrating the importance of palmitoleic acid to regulating metabolism. 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,” state Drs. Roizen and Bernstein in their conclusions.

“We very pleased with the findings and are encouraged by the acceptance of this report by the Journal of Clinical Lipidology,” says Lochlainn O’Haimhirgin, President of Tersus Pharmaceuticals, LLC.

About Provinal®:

Provinal® is an ultra-purified Omega 7 Fatty Acid blend developed by Tersus Pharmaceuticals, a Cleveland biopharmaceutical firm that was the recipient of one of the Therapeutic Discovery Grants for Groundbreaking Medical Research.
Provinal™ Purified Omega 7 fatty acids are purified through a patented 7-step purification process, to express high levels of palmitoleic acid (C16:1n7).

The Product – Key Specifications

  • Concentrated Palmitoleic Acid in Ethyl Ester Form
  • NLT 50.0% Palmitoleic Acid (C16:1n7)
  • NMT 1.0% Palmitic Acid
  • Available in 180 kg and 24 kg Drums
  • Produced in State of the Art GMP Approved Facility (KFDA Approved)

About Tersus Pharaceuticals, LLC:

In a few short years, Cleveland, Ohio-based Tersus Pharmaceuticals, LLC. has positioned itself as the nation’s leading biopharmaceutical firm conducting research, development, and commercialization of purified Omega 7 fatty acids.

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