The Effect of Avocado Consumption on Vascular Health

NCT01595607 | Completed

• 1 other identifier: HS39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Focus: Avocado Consumption & Vascular Health

Outcome Measures

Primary Outcomes (1)

• Change in Endothelial Function

  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.

  0 hr and 3 hr at baseline and after 6 weeks

Secondary Outcomes (3)

• Change in Blood Pressure

  Baseline and after 6 weeks

• Change in Gene Expression

  Baseline and after 6 weeks

• Change in Biomarkers of Cardiovascular Disease Risk

  Baseline and after 6 weeks

Study Arms (2)

Typical American Diet

ACTIVE COMPARATOR

Participants will receive a typical American diet for 6 weeks.

Other: Diet Treatment

Avocado Diet

EXPERIMENTAL

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.

Other: Diet Treatment

Interventions

Diet Treatment OTHER

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.

Avocado Diet; Typical American Diet

Eligibility Criteria

• Age: 28 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead
• Hass Avocado Board: collaborator

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: May 10, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

US (1)