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

NCT01235832 | Completed

• 1 other identifier: PKE 106
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Disease; Hyperlipidemia

Keywords

cholesterol; triglycerides; low-density lipoprotein; high-density lipoprotein; reverse cholesterol transport

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Oxidized-LDL

  The end of each diet period

• lipid hydroperoxide

  The end of each diet period

• Macrophage Cholesterol efflux

  The end of each diet period

• HDL anti-inflammatory function

  The end of each diet period

• Serum fatty acid profile

  The end of each diet period

Study Arms (3)

Lower-Fat Diet

ACTIVE COMPARATOR

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: Lower-Fat Diet

Moderate Fat Diet

ACTIVE COMPARATOR

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: Moderate Fat Diet

Avocado Diet

EXPERIMENTAL

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: Avocado Diet

Interventions

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.

Also known as: moderate fat plus avocado

Avocado Diet

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.

Also known as: lower-fat,low SFA diet

Lower-Fat 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.

Also known as: moderate fat without avocado

Moderate Fat Diet

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Hass Avocado Board: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• 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.

  PMID: 31909809 DERIVED

• 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.

  PMID: 31616932 DERIVED

• 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.

  PMID: 25567051 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Penny M Kris-Etherton, Dr.

  Penn State University

  PRINCIPAL INVESTIGATOR

• Li Wang

  Penn State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)