- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595607
The Effect of Avocado Consumption on Vascular Health
February 23, 2016 updated by: Janet Novotny, USDA Beltsville Human Nutrition Research Center
The Influence of Daily Consumption of Avocado on Biomarkers of Vascular Health
The study will investigate the effect of avocado consumption on markers of vascular health.
Sixty participants will be enrolled in the 6-week study.
A randomized parallel design will be utilized.
Participants will either receive a typical American diet, or a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat, to allow the isoenergetic inclusion of avocado.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Beltsville, Maryland, United States, 20705
- USDA Beltsville Human Nutrition Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI between 25 and 42 kg/m2
- Age 28 to 70 years during the intervention
- Fasting glucose ≤ 126 mg/dl
- Blood pressure ≤ 160/100 mm Hg
Exclusion Criteria:
- Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
- Volunteers who have lost 10% of body weight within the last 12 months
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity
- Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
- Smokers or other tobacco users (during the 6 months prior to the start of the study)
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Typical American Diet
Participants will receive a typical American diet for 6 weeks.
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Participants will consume a controlled diet for 6 weeks where all meals will be provided by the facility.
Participants will be instructed to eat all foods and only foods provided to them.
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Experimental: Avocado Diet
Participants will receive a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat to allow the inclusion of avocado.
|
Participants will consume a controlled diet for 6 weeks where all meals will be provided by the facility.
Participants will be instructed to eat all foods and only foods provided to them.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Endothelial Function
Time Frame: 0 hr and 3 hr at baseline and after 6 weeks
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Noninvasive endothelial function will be assessed, following a 12-hours fast, by measuring endothelium-dependent flow mediated dilation of the peripheral bed.
Participants will then consume a test meal and endothelial function will be assessed again 3 hours later.
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0 hr and 3 hr at baseline and after 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Pressure
Time Frame: Baseline and after 6 weeks
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Blood pressure will be measured using a standardized protocol at the beginning and end of the intervention.
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Baseline and after 6 weeks
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Change in Gene Expression
Time Frame: Baseline and after 6 weeks
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Blood samples will be used to test how the intervention affects gene expression.
The expression of genes related to cardiovascular disease risk will be measured at the beginning and end of the 6-week intervention (fasted and post-prandially).
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Baseline and after 6 weeks
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Change in Biomarkers of Cardiovascular Disease Risk
Time Frame: Baseline and after 6 weeks
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Blood will be collected at the beginning and end of the dietary intervention, following the endothelial function measurements (fasted and post-prandial collections).
Blood will be assessed for biomarkers of cardiovascular disease risk, including electrolytes (sodium, potassium, chloride), markers of inflammation (IL-6, IL-10, IL-1 beta, C-reactive protein, TNF-alpha, fibrinogen, ICAM), markers of vascular function (endothelin-1, factor VII, plasminogen), and blood lipid panel (plasma total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides).
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Baseline and after 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
May 8, 2012
First Posted (Estimate)
May 10, 2012
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- HS39
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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