search
Back to results

Effect of Palmitoleic Acid on C-reactive Protein

Primary Purpose

Chronic Inflammation, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Palmitoleic acid, 500 mg (Dose 1)
Palmitoleic acid, 1,000 mg (Dose 2)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammation focused on measuring palmitoleic acid, monounsaturated fatty acid, chronic inflammation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject will be free-living, middle-aged to older men and women between ages 18-80 years with BMIs between 20.0-40.0, 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

Sites / Locations

  • University of North Carolina Nutrition Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Palmitoleic acid, 500 mg (Dose 1)

Palmitoleic acid, 1,000 mg (Dose 2)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Mean c-reactive protein circulating level
Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.

Secondary Outcome Measures

Mean circulating cytokine IL-6 level
Fasting blood draws will be used to evaluate circulating cytokine IL-6 level by ELISA (enzyme-linked immunosorbent assay).
Mean circulating cytokine TNF alpha level
Fasting blood draws will be used to evaluate circulating cytokine TNF alpha level by ELISA (enzyme-linked immunosorbent assay).
Mean circulating ghrelin level
Fasting blood draws will be used to evaluate circulating ghrelin level by ELISA (enzyme-linked immunosorbent assay).
Mean circulating peptide YY level
Fasting blood draws will be used to evaluate circulating peptide YY level by ELISA (enzyme-linked immunosorbent assay).
Mean circulating leptin level
Fasting blood draws will be used to evaluate circulating leptin level by ELISA (enzyme-linked immunosorbent assay).
Mean circulating adiponectin level
Fasting blood draws will be used to evaluate circulating adiponectin level by ELISA (enzyme-linked immunosorbent assay).
Mean glucose/insulin ratio level
Fasting blood draws will be used to evaluate glucose/insulin ratio level.
Mean HbA1c level
Fasting blood draws will be used to evaluate HbA1c level.

Full Information

First Posted
August 7, 2018
Last Updated
November 29, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Organic Technologies
search

1. Study Identification

Unique Protocol Identification Number
NCT03625427
Brief Title
Effect of Palmitoleic Acid on C-reactive Protein
Official Title
Effects of Palmitoleic Acid on Circulating C-reactive Protein Levels in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Organic Technologies

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammation, Overweight
Keywords
palmitoleic acid, monounsaturated fatty acid, chronic inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Palmitoleic acid, 500 mg (Dose 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Palmitoleic acid, 1,000 mg (Dose 2)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Olive oil
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Palmitoleic acid, 500 mg (Dose 1)
Other Intervention Name(s)
POA
Intervention Description
Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA
Intervention Type
Dietary Supplement
Intervention Name(s)
Palmitoleic acid, 1,000 mg (Dose 2)
Other Intervention Name(s)
POA
Intervention Description
Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA
Primary Outcome Measure Information:
Title
Mean c-reactive protein circulating level
Description
Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Mean circulating cytokine IL-6 level
Description
Fasting blood draws will be used to evaluate circulating cytokine IL-6 level by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Week 12
Title
Mean circulating cytokine TNF alpha level
Description
Fasting blood draws will be used to evaluate circulating cytokine TNF alpha level by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Week 12
Title
Mean circulating ghrelin level
Description
Fasting blood draws will be used to evaluate circulating ghrelin level by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Week 12
Title
Mean circulating peptide YY level
Description
Fasting blood draws will be used to evaluate circulating peptide YY level by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Week 12
Title
Mean circulating leptin level
Description
Fasting blood draws will be used to evaluate circulating leptin level by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Week 12
Title
Mean circulating adiponectin level
Description
Fasting blood draws will be used to evaluate circulating adiponectin level by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Week 12
Title
Mean glucose/insulin ratio level
Description
Fasting blood draws will be used to evaluate glucose/insulin ratio level.
Time Frame
Week 12
Title
Mean HbA1c level
Description
Fasting blood draws will be used to evaluate HbA1c level.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject will be free-living, middle-aged to older men and women between ages 18-80 years with BMIs between 20.0-40.0, and CRP greater than or equal to 2.0 mg/L Generally healthy adults Understand protocol and comply to take supplements during the trial Ability to understand English Be able to report to clinical research center, fasting, at least 3 times Women who are of childbearing potential should be on birth control (one method is acceptable) Exclusion Criteria: BMI higher than 40.0 Taking anti-hyperlipidemia medications (including statins) Taking anti-diabetic medications Auto-immune disease Documented cognitive impairment Unable to draw blood from veins Alcohol or other drug dependency Are currently breastfeeding, or pregnant, or plan to become pregnant Have experienced a significant weight change of 10%, or more, of body weight in previous 3 months If on hormone therapy, no change during study Chronic use of NSAIDs Decreased QOL due to pathology, such as cancer, genetic diseases, Rx side effects, or injury Taking fish oil, within 8 weeks of enrollment Taking Seabuckthorn supplements Taking sterols or fat blockers Fish allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saame R Shaikh, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Nutrition Research Institute
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
9 to 36 months following publication.
IPD Sharing 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.
Citations:
PubMed Identifier
28096141
Citation
Frigolet ME, Gutierrez-Aguilar R. The Role of the Novel Lipokine Palmitoleic Acid in Health and Disease. Adv Nutr. 2017 Jan 17;8(1):173S-181S. doi: 10.3945/an.115.011130. Print 2017 Jan.
Results Reference
background
PubMed Identifier
23266767
Citation
Yadav A, Kataria MA, Saini V, Yadav A. Role of leptin and adiponectin in insulin resistance. Clin Chim Acta. 2013 Feb 18;417:80-4. doi: 10.1016/j.cca.2012.12.007. Epub 2012 Dec 22.
Results Reference
background
PubMed Identifier
27814509
Citation
Schirmer M, Smeekens SP, Vlamakis H, Jaeger M, Oosting M, Franzosa EA, Ter Horst R, Jansen T, Jacobs L, Bonder MJ, Kurilshikov A, Fu J, Joosten LAB, Zhernakova A, Huttenhower C, Wijmenga C, Netea MG, Xavier RJ. Linking the Human Gut Microbiome to Inflammatory Cytokine Production Capacity. Cell. 2016 Nov 3;167(4):1125-1136.e8. doi: 10.1016/j.cell.2016.10.020. Erratum In: Cell. 2016 Dec 15;167(7):1897. Cell. 2016 Dec 15;167(7):1897.
Results Reference
background
PubMed Identifier
28980402
Citation
de Souza CO, Vannice GK, Rosa Neto JC, Calder PC. Is Palmitoleic Acid a Plausible Nonpharmacological Strategy to Prevent or Control Chronic Metabolic and Inflammatory Disorders? Mol Nutr Food Res. 2018 Jan;62(1). doi: 10.1002/mnfr.201700504. Epub 2017 Dec 11.
Results Reference
background
PubMed Identifier
25499944
Citation
Bernstein AM, Roizen MF, Martinez L. WITHDRWAN: Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: a double-blinded, randomized, placebo controlled study. J Clin Lipidol. 2014 Nov-Dec;8(6):612-617. doi: 10.1016/j.jacl.2014.08.001. Epub 2014 Aug 19.
Results Reference
result

Learn more about this trial

Effect of Palmitoleic Acid on C-reactive Protein

We'll reach out to this number within 24 hrs