Effect of Palmitoleic Acid on C-reactive Protein
Condition: Chronic Inflammation; Overweight
MeSH terms: Overweight; Inflammation
Study type: Interventional

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.
    

Detailed description: 
      Palmitoleic acid (POA) is a monounsaturated fatty acid that has recently been shown to
      function as a lipokine and is present in the human diet and in blood serum. While there is
      emerging evidence that POA can positively impact beta cell proliferation, reduce lipogenesis,
      support endothelial function, and suppress cytokine production, POA remains to be poorly
      studied for its beneficial anti-inflammatory potential. The latest studies suggest that POA
      could attenuate inflammation in metabolically active tissues. Therefore, the objective of
      this study is to determine if administration of POA in 2 varying doses to overweight
      participants with biomarkers of chronic inflammation will lower circulating c-reactive
      protein (CRP) and cytokine levels, as well as improve metabolism by lowering levels of
      circulating leptin and raising expression of adiponectin. The rationale for focusing on
      overweight individuals is that they routinely have elevated c-reactive protein levels and are
      highly prone to have chronic inflammation.

      Investigators propose a 12-week randomized, double blinded study to assess changes in select
      inflammatory markers, ghrelin, peptide YY, cardiovascular lipids, fatty acid levels, and
      glucose sensitivity markers in volunteers consuming either the test agent, 500 mg or 1,000 mg
      POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study
      and 41 individuals per arm, thus, a total of 123 subjects. Approximately 30% loss of subjects
      is expected. Administration of the POA supplements and placebo (olive oil capsules) will be
      double blinded. The study sponsor will hold the code for the subjects and will randomize the
      capsules. Only the study sponsor will have the code. The identity of the capsules will be
      revealed after the completion of the study. Subjects will bring back their bottles at each of
      the concurrent visits and the end of the study to assess compliance and to account for any
      missed doses of POA. The rationale for selecting olive oil as a placebo is that olive oil is
      routinely consumed by the public. Additionally, oleic acid (the active ingredient of olive
      oil) is the most prevalent fatty acid in human circulation, and olive oil is a routine
      placebo for fatty acid intervention studies. The olive oil will not be extra virgin olive oil
      that has several bioactive components. POA is virtually tasteless, thus participants should
      not be able to self-identify their regimen of either placebo or active test agent. The
      rationale for the experimental dose follows what is commercially available in POA products,
      which average 700 mg per day and generally range from 450 - 1000 mg per day regimens. The
      rationale for the 12-week time frame is to ensure uptake of POA into the target cells.
    

Intervention name(s): Placebo; Palmitoleic acid, 500 mg (Dose 1); Palmitoleic acid, 1,000 mg (Dose 2)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA; Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA
Other intervention name(s): Olive oil; POA; POA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 12-week randomized, double blinded study in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: palmitoleic acid; monounsaturated fatty acid; chronic inflammation