The Effect of Avocado on Cardiovascular Disease (CVD) Risk Factors

Cardiovascular Disease Clinical Trial

Official title:

The Effect of One Avocado Per Day on Established and Emerging Cardiovascular Disease (CVD) Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235832
• Other study ID #: PKE 106
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: February 2013

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose to evaluate the effects of avocado consumption (by incorporating 1 unit of fruit per day into a healthy diet) on multiple cardiovascular disease (CVD) risk factors. The investigators will compare chronic consumption of a moderate fat blood cholesterol-lowering diet incorporating one avocado per day versus a blood cholesterol-lowering Lower-Fat diet on established CVD risk factors including lipids and lipoproteins, and blood pressure (BP). The investigators also will evaluate the effects of an avocado diet on several emerging CVD risk factors. To elucidate the specific benefits of avocado and its accompanying bioactives on the aforementioned risk factors, the investigators will compare the avocado diet with a diet that has the same macronutrient profile (but without the avocado).

Description:

A randomized, 3-period cross-over, controlled feeding study was designed to compare the effects of a moderate fat blood cholesterol-lowering diet that provides one avocado per day (total fat = 34% total energy, MUFA=18%, SFA <7%) to an Average American diet (AAD), Lower-Fat diet (total fat = 24% total energy, SFA <7%), and Moderate Fat diet (with equivalent fatty acid profile to the avocado diet) without avocado. The study population consists of 40 overweight (BMI25-35 kg/m2) men and women with moderately elevated LDL-C, between the25-90th percentiles from NHANES. The investigators hypothesize that a moderate fat heart-healthy diet, including 1 avocado per day will reduce CVD risk factors including lipids, lipoproteins, apolipoproteins, lipoprotein particle size, markers of oxidative stress and inflammation, blood pressure and reverse cholesterol transport compared to an AAD, Lower-Fat diet, and moderate fat diet without avocado.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• healthy non-smoking

• overweight (BMI 25-35 kg/m2) men and women

• LDL-C between the25-90th percentile from NHANES: 105-194mg/dL for males; 98-190mg/dL for females)

Exclusion Criteria:

• BP >140/90 mmHg;

• A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication);

• Lactation, pregnancy, or desire to become pregnant during the study;

• Cholesterol-lowering medication use;

• Intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods);

• Vegetarianism;

• Nut allergies (Other food allergies were reviewed on a case-by-case basis);

• Refusal to discontinue nutritional supplements, herbs or vitamins

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hyperlipidemia
• Hyperlipidemias

Intervention

Other:
• Avocado Diet
The avocado diet will be designed to ensure that all subjects incorporate 1 avocado (~136g) per day into a moderate fat diet. Both the Lower-Fat diet and avocado diet will be matched for SFA and dietary cholesterol, but will differ in total fat, primarily MUFA as provided by the avocado. The moderate fat plus avocado diet will provide 34% of calories from total fat, 18% calories from MUFA, and 9% calories from PUFA.
• Lower-Fat Diet
The Lower-Fat diet will provide ~24% of calories from fat and meet the SFA and cholesterol recommendations of a Step-II diet recommended by the National Heart, Lung, and Blood Association's National Cholesterol Education Program. SFA will provide 7% of calories, and cholesterol will be less than 200mg/day. Vegetables and fruits in the Lower-Fat diet will be selected from foods that are low in antioxidants.
• Moderate Fat Diet
This diet is designed to be the control diet for the avocado diet and will have an identical fatty acid profile. MUFA-enriched food (fats) will be substituted for avocado. The substitution foods will not contain antioxidant or cholesterol-lowering components similar to those in avocado.

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Hass Avocado Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipids and lipoproteins	Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides are measured as part of the lipids and lipoprotein profile.; Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Primary	Lipoprotein particle size	Advanced lipoprotein testing is used to measure LDL particle size and subclasses of HDL and VLDL.; Diet period one runs for 5 weeks after a 2-week run-in diet (baseline), then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Secondary	Oxidized-LDL	Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Secondary	lipid hydroperoxide	Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Secondary	Macrophage Cholesterol efflux	Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Secondary	HDL anti-inflammatory function	Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Secondary	Serum fatty acid profile	Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of each diet period
Secondary	Inflammatory biomarkers	CRP and IL-6 are measured as the markers of inflammation.; Diet period one runs for 5 weeks after a 2-week run-in diet, then there is a 2-3 week compliance break, and then diet period two runs for another 5 weeks; then there is a 2-3 week compliance break, and then diet period three runs for another 5 weeks	The end of diet period