NCT01397071

Brief Summary

Avocados are naturally rich in antioxidants, or beneficial compounds, that can help prevent many diseases, like atherosclerosis (hardening of the arteries). When foods that are high in fats are eaten, certain harmful compounds can be absorbed, which can lead to atherosclerosis. One harmful compound is called malondialdehyde, or MDA. This compound can be measured in the blood and the urine after a person eats a high fat meal. Antioxidants found in herbs and spices may lower the absorption of MDA, which could help prevent the development of atherosclerosis. This study will determine whether the beneficial compounds of avocado can reduce absorption of MDA. This will be tested by asking healthy males to eat a high fat ground beef patty with or without avocado and then measuring the amount of MDA in their blood and urine samples. Blood flow will also be measured. Healthy men have been chosen for this study because eating high fat hamburger patties can easily mimic in them the condition that causes atherosclerosis. Avocados are rich in antioxidants, which have been shown in previous studies to reduce the absorption of harmful compounds, like MDA, that are formed during cooking. The results from this study may help to explain how high fat foods can be harmful to the body and how beneficial antioxidants from herbs and spices can protect the body. This will be determined from blood and urine samples after the subjects are given two different meals: a) a plain cooked ground beef patty, and b) or avocado with a cooked ground beef patty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

July 18, 2011

Results QC Date

October 23, 2018

Last Update Submit

September 23, 2019

Conditions

Keywords

Avocado, antioxidant

Outcome Measures

Primary Outcomes (1)

  • Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)

    Change from baseline in reactive hyperemia index (RHI) in response to consumption of 250 g beef patty with or without 68 g avocado added at 2 hour post-ingestion. RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function.

    Baseline and 2 hours post-ingestion

Secondary Outcomes (1)

  • Change in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)

    0 (baseline) and 3 hours post-ingestion

Study Arms (2)

Ground Beef Patty with Avocado

ACTIVE COMPARATOR

Test burgers with fresh avocado added just prior to consumption

Other: Avocado

Ground Beef Patty without Avocado

ACTIVE COMPARATOR

Test burgers

Other: Avocado

Interventions

AvocadoOTHER

Fresh Avocado

Ground Beef Patty with AvocadoGround Beef Patty without Avocado

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old males (inclusive)
  • Non-smokers
  • Must weigh a minimum of 110 pounds
  • Willing to maintain normal activity and eating patterns for the duration of the study
  • Willing to maintain their normal diet for the duration of the study but avoid dairy, avocado and meat products.

You may not qualify if:

  • Females
  • Abnormal liver function (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2 x upper limit)
  • Currently taking steroidal drugs
  • Known HIV positive or AIDS
  • Chronic infectious disease
  • Cancer treated within the past two years
  • Participation in a therapeutic research study within 30 days of baseline
  • Consumption of vegetarian diet
  • Allergy or sensitivity to dairy products
  • Allergic to avocado

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Center for Human Nutriiton

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Li Z, Wong A, Henning SM, Zhang Y, Jones A, Zerlin A, Thames G, Bowerman S, Tseng CH, Heber D. Hass avocado modulates postprandial vascular reactivity and postprandial inflammatory responses to a hamburger meal in healthy volunteers. Food Funct. 2013 Feb 26;4(3):384-91. doi: 10.1039/c2fo30226h.

Results Point of Contact

Title
Zhaoping Li
Organization
UCLA Department of Medicine/Center for Human Nutrition

Study Officials

  • David Heber, MD, PhD

    UCLA Center for Human Nutrition

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2012

Study Completion

August 1, 2012

Last Updated

September 25, 2019

Results First Posted

September 25, 2019

Record last verified: 2019-09

Locations