The Effect of Avocado Consumption on Vascular Health

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Focus: Avocado Consumption & Vascular Health

Treatments: Other: Diet Treatment

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01595607

HS39

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 28 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Typical American Diet

Active Comparator group

Description:

Participants will receive a typical American diet for 6 weeks.

Treatment:

Other: Diet Treatment

Avocado Diet

Experimental group

Description:

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.

Treatment:

Other: Diet Treatment