Clinical trial NCT01235832: The Effect of Avocado on Cardiovascular Disease (CVD) Risk Factors
Official title: The Effect of One Avocado Per Day on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Hyperlipidemia
Keywords: cholesterol
triglycerides
low-density lipoprotein
high-density lipoprotein
reverse cholesterol transport
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Hass Avocado Board
First posted: 2010-11-08
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipids and lipoproteins
timeFrame: The end of each diet period
measure: Lipoprotein particle size
timeFrame: The end of each diet period
Secondary outcomes:
measure: Oxidized-LDL
timeFrame: The end of each diet period
measure: lipid hydroperoxide
timeFrame: The end of each diet period
measure: Macrophage Cholesterol efflux
timeFrame: The end of each diet period
measure: HDL anti-inflammatory function
timeFrame: The end of each diet period
measure: Serum fatty acid profile
timeFrame: The end of each diet period
measure: Inflammatory biomarkers
timeFrame: The end of diet period
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Penny M Kris-Etherton, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Li Wang
role: STUDY_DIRECTOR
References:
citation: Tindall AM, Kris-Etherton PM, Petersen KS. Replacing Saturated Fats with Unsaturated Fats from Walnuts or Vegetable Oils Lowers Atherogenic Lipoprotein Classes Without Increasing Lipoprotein(a). J Nutr. 2020 Apr 1;150(4):818-825. doi: 10.1093/jn/nxz313.
citation: Wang L, Tao L, Hao L, Stanley TH, Huang KH, Lambert JD, Kris-Etherton PM. A Moderate-Fat Diet with One Avocado per Day Increases Plasma Antioxidants and Decreases the Oxidation of Small, Dense LDL in Adults with Overweight and Obesity: A Randomized Controlled Trial. J Nutr. 2020 Feb 1;150(2):276-284. doi: 10.1093/jn/nxz231.
citation: Wang L, Bordi PL, Fleming JA, Hill AM, Kris-Etherton PM. Effect of a moderate fat diet with and without avocados on lipoprotein particle number, size and subclasses in overweight and obese adults: a randomized, controlled trial. J Am Heart Assoc. 2015 Jan 7;4(1):e001355. doi: 10.1161/JAHA.114.001355.