A Multicenter Pilot Study to Evaluate the Effect of EVOO on Lipid Parameters

NCT04760093 | Completed

• 1 other identifier: 1639676
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this multi-center, double-blinded pilot study is to determine if extra virgin olive oil (EVOO) has a positive effect on HDL cholesterol levels and anti-inflammatory markers for subjects diagnosed with cardiovascular disease (CVD) and to determine if the polyphenol concentration is proportional to those effects. Subjects will complete consecutive 28-day periods (with a 14-day washout between) in which they will either consume the low polyphenol concentration EVOO daily or the high polyphenol concentration EVOO. In a double-blinded manner, each subject will be his or her own control with a 14-day washout between study periods. HDL levels and other parameters will be measured after each period of the protocol. The investigators anticipate HDL levels will improve with both olive oils. The investigators expect the high polyphenol concentration EVOO will show a greater effect than the EVOO with a low polyphenol concentration. EVOO with high polyphenol concentration may be a simple method to reduce the risk of secondary CVD events.

Conditions

Cardiovascular Diseases

Keywords

Lipoproteins, HDL; Extra virgin olive oil

Outcome Measures

Primary Outcomes (1)

• HDL

  Average difference in HDL in subjects who consumed low polyphenol vs. high polyphenol EVOO.

  HDL will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.

Secondary Outcomes (5)

• IL-6

  IL-6 will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.

• CRP

  CRP will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.

• Lipid panel

  Lipid panels will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.

• Blood pressure

  Blood pressure will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.

• Heart rate

  Heart rate will be measured in each subject within 28 days before and within 28 days after consuming either low or high polyphenol EVOO.

Study Arms (2)

Low-to-High group

OTHER

As this is a crossover study, each participant will be assigned to each treatment intervention. Participants (randomly) assigned to Arm 1 will first receive low polyphenol concentration EVOO for consumption, followed by high polyphenol concentration EVOO for consumption following a 14- day washout phase.

Dietary Supplement: Low polyphenol concentration extra virgin olive oil (EVOO); Dietary Supplement: High polyphenol concentration extra virgin olive oil (EVOO)

High-to-Low group

OTHER

As this is a crossover study, each participant will be assigned to each treatment intervention. Participants (randomly) assigned to Arm 2 will first receive high polyphenol concentration EVOO for consumption, followed by low polyphenol concentration EVOO for consumption following a 14- day washout phase.

Dietary Supplement: Low polyphenol concentration extra virgin olive oil (EVOO); Dietary Supplement: High polyphenol concentration extra virgin olive oil (EVOO)

Interventions

Low polyphenol concentration extra virgin olive oil (EVOO) DIETARY_SUPPLEMENT

Subjects will complete a consecutive 28-day period of consuming low polyphenol concentration EVOO daily.

High-to-Low group; Low-to-High group

High polyphenol concentration extra virgin olive oil (EVOO) DIETARY_SUPPLEMENT

Subjects will complete a consecutive 28-day period of consuming high polyphenol concentration EVOO daily.

High-to-Low group; Low-to-High group

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Both males and females will be included
• Known cardiovascular disease as documented by ICD code
• HDL \< 40 documented within the past 12 months
• Able to fast for 12 hours prior to blood draws

You may not qualify if:

• Unwilling or unable to provide informed consent for any reason
• Inability to adhere to protocol for any reason
• Currently using EVOO on a daily basis
• Change in use of lipid lowering medications or supplements in the past 90 days or plans to change during study participation
• HDL \> 40 on baseline blood draw
• Significant change in diet or exercise in the past 30 days or plan to do so during the study time period
• Allergic to olive oil
• Unable to fast for 12 hours prior to blood draws
• Pregnancy
• Enrolled in another interventional research study
• Non-English speaking

Sponsors & Collaborators

• Ralph Hamill: lead

Study Sites (3)

Mid Coast Cardiology

Brunswick, Maine, 04011, United States

Location

Pen Bay Medical Center

Rockport, Maine, 04856, United States

Location

Maine Medical Partners Cardiology

Scarborough, Maine, 04074, United States

Location

Related Publications (9)

• Buckland G, Travier N, Barricarte A, Ardanaz E, Moreno-Iribas C, Sanchez MJ, Molina-Montes E, Chirlaque MD, Huerta JM, Navarro C, Redondo ML, Amiano P, Dorronsoro M, Larranaga N, Gonzalez CA. Olive oil intake and CHD in the European Prospective Investigation into Cancer and Nutrition Spanish cohort. Br J Nutr. 2012 Dec 14;108(11):2075-82. doi: 10.1017/S000711451200298X. Epub 2012 Sep 25.

  PMID: 23006416 BACKGROUND

• Caporaso, N., Savarese, M., Paduano, A., Guidone, G., De Marco, E., & Sacchi, R. (2015). Nutritional quality assessment of extra virgini olive oil from the Italian retail market: Do natural antioxidants satisfy EFSA health claims? Journal of Food Composition and Analysis, 40, 154-162. doi:10.1016/j.jfca.2014.12.012

  BACKGROUND

• Estruch R, Lamuela-Raventos RM, Ros E. The Bitter Taste of Extra Virgin Olive Oil for a Sweet Long Life. J Am Coll Cardiol. 2020 Apr 21;75(15):1740-1742. doi: 10.1016/j.jacc.2020.02.043. No abstract available.

  PMID: 32299584 BACKGROUND

• Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Ruiz-Gutierrez V, Covas MI, Fiol M, Gomez-Gracia E, Lopez-Sabater MC, Vinyoles E, Aros F, Conde M, Lahoz C, Lapetra J, Saez G, Ros E; PREDIMED Study Investigators. Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11. doi: 10.7326/0003-4819-145-1-200607040-00004.

  PMID: 16818923 BACKGROUND

• Fiorini D, Boarelli MC, Conti P, Alfei B, Caprioli G, Ricciutelli M, Sagratini G, Fedeli D, Gabbianelli R, Pacetti D. Chemical and sensory differences between high price and low price extra virgin olive oils. Food Res Int. 2018 Mar;105:65-75. doi: 10.1016/j.foodres.2017.11.005. Epub 2017 Nov 6.

  PMID: 29433259 BACKGROUND

• Guasch-Ferre M, Liu G, Li Y, Sampson L, Manson JE, Salas-Salvado J, Martinez-Gonzalez MA, Stampfer MJ, Willett WC, Sun Q, Hu FB. Olive Oil Consumption and Cardiovascular Risk in U.S. Adults. J Am Coll Cardiol. 2020 Apr 21;75(15):1729-1739. doi: 10.1016/j.jacc.2020.02.036. Epub 2020 Mar 5.

  PMID: 32147453 BACKGROUND

• Khan TM, Iqbal S, Rashid MA. Comparison Of Lipid Lowering Effect Of Extra Virgin Olive Oil And Atorvastatin In Dyslipidaemia In Type 2 Diabetes Mellitus. J Ayub Med Coll Abbottabad. 2017 Jan-Mar;29(1):83-86.

  PMID: 28712181 BACKGROUND

• Rahilly-Tierney CR, Spiro A 3rd, Vokonas P, Gaziano JM. Relation between high-density lipoprotein cholesterol and survival to age 85 years in men (from the VA normative aging study). Am J Cardiol. 2011 Apr 15;107(8):1173-7. doi: 10.1016/j.amjcard.2010.12.015. Epub 2011 Feb 4.

  PMID: 21296318 BACKGROUND

• Servili M, Esposto S, Fabiani R, Urbani S, Taticchi A, Mariucci F, Selvaggini R, Montedoro GF. Phenolic compounds in olive oil: antioxidant, health and organoleptic activities according to their chemical structure. Inflammopharmacology. 2009 Apr;17(2):76-84. doi: 10.1007/s10787-008-8014-y.

  PMID: 19234678 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ralph Hamill, MD

  Maine Medical Partners

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Pharmacists will assign participants to one of the research arms following a randomization schedule, and will maintain a study log not accessible to the investigators or care provider. Study coordinators will remain blinded when distributing the bottles of EVOO.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist

Model Details: In this study, subjects will be randomized to one of two research arms. Subjects in the first research arm will be given low polyphenol concentration EVOO, followed by high polyphenol concentration EVOO for consumption. Subjects in the second research arm will be given high polyphenol concentration EVOO, followed by low polyphenol concentration EVOO for consumption. There will be a 14- day washout period in between administration of either low or high polyphenol concentration EVOO.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 18, 2021
• Study Start: July 26, 2021
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)