Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men
Hass Avocado Flesh Inhibition of Appearance of Lipid Peroxidation Products When Added to a Ground Beef Patty Consumed by Healthy Volunteers
1 other identifier
interventional
11
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started Aug 2011
Typical duration for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
September 25, 2019
CompletedSeptember 25, 2019
September 1, 2019
6 months
July 18, 2011
October 23, 2018
September 23, 2019
Conditions
Keywords
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 COMPARATORTest burgers with fresh avocado added just prior to consumption
Ground Beef Patty without Avocado
ACTIVE COMPARATORTest burgers
Interventions
Eligibility Criteria
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
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.
PMID: 23196671RESULT
Results Point of Contact
- Title
- Zhaoping Li
- Organization
- UCLA Department of Medicine/Center for Human Nutrition
Study Officials
- PRINCIPAL INVESTIGATOR
David Heber, MD, PhD
UCLA Center for Human Nutrition
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