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

Primary Purpose

Cardiovascular Disease, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avocado Diet
Lower-Fat Diet
Moderate Fat Diet
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, reverse cholesterol transport

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Lower-Fat Diet

Moderate Fat Diet

Avocado Diet

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
November 5, 2010
Last Updated
August 16, 2023
Sponsor
Penn State University
Collaborators
Hass Avocado Board
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1. Study Identification

Unique Protocol Identification Number
NCT01235832
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
Hass Avocado Board

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Hyperlipidemia
Keywords
cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, reverse cholesterol transport

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower-Fat Diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Moderate Fat Diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Avocado Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Avocado Diet
Other Intervention Name(s)
moderate fat plus avocado
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lower-Fat Diet
Other Intervention Name(s)
lower-fat,low SFA diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate Fat Diet
Other Intervention Name(s)
moderate fat without avocado
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lipids and lipoproteins
Description
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
Time Frame
The end of each diet period
Title
Lipoprotein particle size
Description
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
Time Frame
The end of each diet period
Secondary Outcome Measure Information:
Title
Oxidized-LDL
Description
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
Time Frame
The end of each diet period
Title
lipid hydroperoxide
Description
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
Time Frame
The end of each diet period
Title
Macrophage Cholesterol efflux
Description
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
Time Frame
The end of each diet period
Title
HDL anti-inflammatory function
Description
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
Time Frame
The end of each diet period
Title
Serum fatty acid profile
Description
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
Time Frame
The end of each diet period
Title
Inflammatory biomarkers
Description
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
Time Frame
The end of diet period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny M Kris-Etherton, Dr.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Wang
Organizational Affiliation
Penn State University
Official's Role
Study Director
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31909809
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.
Results Reference
derived
PubMed Identifier
31616932
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.
Results Reference
derived
PubMed Identifier
25567051
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.
Results Reference
derived

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

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