- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235832
The Effect of Avocado on Cardiovascular Disease (CVD) Risk Factors
The Effect of One Avocado Per Day on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Penn State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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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:
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Active Comparator: 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.
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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:
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Experimental: 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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipids and lipoproteins
Time Frame: The end of each diet period
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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
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Lipoprotein particle size
Time Frame: The end of each diet period
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidized-LDL
Time Frame: The end of each diet period
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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
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The end of each diet period
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lipid hydroperoxide
Time Frame: The end of each diet period
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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
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The end of each diet period
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Macrophage Cholesterol efflux
Time Frame: The end of each diet period
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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
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The end of each diet period
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HDL anti-inflammatory function
Time Frame: The end of each diet period
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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
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The end of each diet period
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Serum fatty acid profile
Time Frame: The end of each diet period
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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
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The end of each diet period
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Inflammatory biomarkers
Time Frame: The end of diet period
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Penny M Kris-Etherton, Dr., Penn State University
- Study Director: Li Wang, Penn State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKE 106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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