Clinical trial NCT01595607: The Effect of Avocado Consumption on Vascular Health
Official title: The Influence of Daily Consumption of Avocado on Biomarkers of Vascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus: Avocado Consumption & Vascular Health
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Hass Avocado Board
First posted: 2012-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Endothelial Function
timeFrame: 0 hr and 3 hr at baseline and after 6 weeks
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline and after 6 weeks
measure: Change in Gene Expression
timeFrame: Baseline and after 6 weeks
measure: Change in Biomarkers of Cardiovascular Disease Risk
timeFrame: Baseline and after 6 weeks
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: