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NCT Number: NCT01235832

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

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).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avocado Diet

Other

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.

Other names: moderate fat plus avocado

Lower-Fat Diet

Other

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.

Other names: lower-fat,low SFA diet

Moderate Fat Diet

Other

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.

Other names: moderate fat without avocado

Primary outcomes

  1. Lipids and lipoproteins

    Time frame: The end of each diet period

    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

  2. Lipoprotein particle size

    Time frame: The end of each diet period

    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

Secondary outcomes

  1. Oxidized-LDL

    Time frame: The end of each diet period

    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

  2. lipid hydroperoxide

    Time frame: The end of each diet period

    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

  3. Macrophage Cholesterol efflux

    Time frame: The end of each diet period

    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

  4. HDL anti-inflammatory function

    Time frame: The end of each diet period

    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

  5. Serum fatty acid profile

    Time frame: The end of each diet period

    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

  6. Inflammatory biomarkers

    Time frame: The end of diet period

    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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Hass Avocado Board

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 8, 2010
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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