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Trial record 39 of 99 for:    Oleic Acids

Effect of Palmitoleic Acid on C-reactive Protein

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ClinicalTrials.gov Identifier: NCT03625427
Recruitment Status : Not yet recruiting
First Posted : August 10, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Inflammation Overweight Dietary Supplement: Placebo Dietary Supplement: Palmitoleic acid, 500 mg (Dose 1) Dietary Supplement: Palmitoleic acid, 1,000 mg (Dose 2) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
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)
Masking Description: Administration of the POA supplements and placebo (olive oil capsules) will be via a simple randomized double-blinded allocation. The study sponsor will provide the Principal Investigator with bags, or boxes, of single serve packets containing two capsules for each daily dose per participant in accordance with the proper dosage for each of the three arms of the study. The study sponsor will hold the code for the subjects and will randomize the capsules. No site personnel will have access to the randomization allocation; only the study sponsor will have the code. The identity of the capsules will be revealed once all analyses are complete.
Primary Purpose: Treatment
Official Title: Effects of Palmitoleic Acid on Circulating C-reactive Protein Levels in Humans
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Placebo Comparator: Placebo
The placebo is olive oil, stripped of polyphenols, 70% oleic acid, and will be administered at two 1 gram capsules per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.
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.
Other Name: Olive oil

Experimental: Palmitoleic acid, 500 mg (Dose 1)
POA Dose 1 is a 1 gram capsule containing 500 mg POA and one placebo capsule containing 500 mg olive oil per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.
Dietary Supplement: Palmitoleic acid, 500 mg (Dose 1)
Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA
Other Name: POA

Experimental: Palmitoleic acid, 1,000 mg (Dose 2)
POA Dose 2 is two, 1 gram capsules containing 500 mg POA, totaling 1,000 mg POA per day for twelve weeks.The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.
Dietary Supplement: Palmitoleic acid, 1,000 mg (Dose 2)
Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA
Other Name: POA




Primary Outcome Measures :
  1. Mean c-reactive protein circulating level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.


Secondary Outcome Measures :
  1. Mean circulating cytokine IL-6 level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating cytokine IL-6 level by ELISA (enzyme-linked immunosorbent assay).

  2. Mean circulating cytokine TNF alpha level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating cytokine TNF alpha level by ELISA (enzyme-linked immunosorbent assay).

  3. Mean circulating ghrelin level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating ghrelin level by ELISA (enzyme-linked immunosorbent assay).

  4. Mean circulating peptide YY level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating peptide YY level by ELISA (enzyme-linked immunosorbent assay).

  5. Mean circulating leptin level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating leptin level by ELISA (enzyme-linked immunosorbent assay).

  6. Mean circulating adiponectin level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate circulating adiponectin level by ELISA (enzyme-linked immunosorbent assay).

  7. Mean glucose/insulin ratio level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate glucose/insulin ratio level.

  8. Mean HbA1c level [ Time Frame: Week 12 ]
    Fasting blood draws will be used to evaluate HbA1c level.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject will be free-living, middle-aged to older men and women between ages 30-80 years with BMIs between 25.0-40.0, and CRP greater than or equal to 2.0 mg/L
  2. Generally healthy adults
  3. Understand protocol and comply to take supplements during the trial
  4. Ability to understand English
  5. Be able to report to clinical research center, fasting, at least 3 times
  6. Women who are of childbearing potential should be on birth control (one method is acceptable)

Exclusion Criteria:

  1. BMI higher than 40.0
  2. Taking anti-hyperlipidemia medications (including statins)
  3. Taking anti-diabetic medications
  4. Auto-immune disease
  5. Documented cognitive impairment
  6. Unable to draw blood from veins
  7. Alcohol or other drug dependency
  8. Are currently breastfeeding, or pregnant, or plan to become pregnant
  9. Have experienced a significant weight change of 10%, or more, of body weight in previous 3 months
  10. If on hormone therapy, no change during study
  11. Chronic use of NSAIDs
  12. Decreased QOL due to pathology, such as cancer, genetic diseases, Rx side effects, or injury
  13. Taking fish oil, within 8 weeks of enrollment
  14. Taking Seabuckthorn supplements
  15. Taking sterols or fat blockers
  16. Fish allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625427


Contacts
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Contact: Tondra S Blevins (704) 305-5709 tondra_blevins@unc.edu
Contact: Traci Davis, MS (919) 843-5145 traci_davis@unc.edu

Locations
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United States, North Carolina
University of North Carolina Nutrition Research Institute Not yet recruiting
Kannapolis, North Carolina, United States, 28081
Contact: Jomari Torres, MD    704-250-5062    jomari_torres@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Saame R Shaikh, PhD University of North Carolina, Chapel Hill

Publications of Results:
Other Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03625427     History of Changes
Other Study ID Numbers: 17-2316
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Supporting Materials: Study Protocol
Time Frame: 9 to 36 months following publication.
Access Criteria: A Data Use Agreement (DUA) specifying the uses of such data to be shared must be in place before any data is shared. The requestor should contact the Principal Investigator for further instruction.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of North Carolina, Chapel Hill:
palmitoleic acid
monounsaturated fatty acid
chronic inflammation

Additional relevant MeSH terms:
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Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms