Effect of Palmitoleic Acid on C-reactive Protein

NCT03625427 | Completed

• 1 other identifier: 17-2316
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammation; Overweight

Keywords

palmitoleic acid; monounsaturated fatty acid; chronic inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (8)

• Mean circulating cytokine IL-6 level

  Week 12

• Mean circulating cytokine TNF alpha level

  Week 12

• Mean circulating ghrelin level

  Week 12

• Mean circulating peptide YY level

  Week 12

• Mean circulating leptin level

  Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Palmitoleic acid, 500 mg (Dose 1)

EXPERIMENTAL

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, 1,000 mg (Dose 2)

EXPERIMENTAL

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)

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Also known as: Olive oil

Placebo

Palmitoleic acid, 500 mg (Dose 1) DIETARY_SUPPLEMENT

Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA

Also known as: POA

Palmitoleic acid, 500 mg (Dose 1)

Palmitoleic acid, 1,000 mg (Dose 2) DIETARY_SUPPLEMENT

Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA

Also known as: POA

Palmitoleic acid, 1,000 mg (Dose 2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Organic Technologies: collaborator

Study Sites (1)

University of North Carolina Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (5)

• 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.

  PMID: 28096141 BACKGROUND

• 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.

  PMID: 23266767 BACKGROUND

• 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.

  PMID: 27814509 BACKGROUND

• 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.

  PMID: 28980402 BACKGROUND

• 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.

  PMID: 25499944 RESULT

MeSH Terms

Conditions

Overweight

Interventions

Olive Oil; palmitoleic acid

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Saame R Shaikh, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: September 26, 2019
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)