The Effect of Avocado on Cardiovascular Disease (CVD) Risk Factors
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Purpose
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).
| Condition | Intervention |
|---|---|
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Cardiovascular Disease |
Other: Avocado Diet Other: Lower-Fat Diet Other: Moderate Fat Diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Effect of One Avocado Per Day on Established and Emerging Cardiovascular Disease (CVD) Risk Factors |
- Lipids and lipoproteins [ Time Frame: The end of each diet period ] [ Designated as safety issue: No ]
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
- Oxidized-LDL [ Time Frame: The end of diet period 1(week7), diet period 2 (week14) , and diet period 3 (week21) ] [ Designated as safety issue: No ]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 [ Time Frame: The end of diet period 1(week7), diet period 2 (week14) , and diet period 3 (week21) ] [ Designated as safety issue: No ]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 [ Time Frame: The end of diet period 1(week7), diet period 2 (week14) , and diet period 3 (week21) ] [ Designated as safety issue: No ]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
| Enrollment: | 54 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: 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.
Other Name: lower-fat,low SFA diet
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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.
|
Other: 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.
Other Name: moderate fat without avocado
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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.
|
Other: 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.
Other Name: moderate fat plus 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| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Penn State University | |
| University Park, Pennsylvania, United States, 16802 | |
| Principal Investigator: | Penny M Kris-Etherton, Dr. | Penn State University |
| Study Director: | Li Wang | Penn State University |
More Information
No publications provided
| Responsible Party: | Penny Kris-Etherton, Distinguished Professor, Penn State University |
| ClinicalTrials.gov Identifier: | NCT01235832 History of Changes |
| Other Study ID Numbers: | PKE 106 |
| Study First Received: | November 5, 2010 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Institutional Review Board; plus study-specific authorities |
Keywords provided by Penn State University:
|
cholesterol triglycerides low-density lipoprotein high-density lipoprotein reverse cholesterol transport |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013