Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01397071
First received: July 18, 2011
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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. Avocadoes are rich in antioxidiants, 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.


Condition Intervention Phase
To Demonstrate a Better Understanding of the Role of
Bioactive Substances From Plant Foods Such as the
Avocado May Demonstrate the Importance of Plant-based
Antioxidants in Human Health
Other: Avocado
Other: No Avocado
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Hass Avocado Flesh Inhibition of Appearance of Lipid Peroxidation Products When Added to a Ground Beef Patty Consumed by Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Plasma [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    1. To measure plasma and urine malondialdehyde by HPLC before and over6 hours after consumption of the test burgers with or without fresh avocado added just prior to consumption.


Secondary Outcome Measures:
  • Insulin [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    2. To measure insulin, glucose, triglycerides, TNF-α, IL-6, IL-8, NFκB activation, nitric oxide and peripheral arterial tonometry after each test burger.


Enrollment: 10
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ground Beef Patty with Avocado
Test burgers with fresh avocado added just prior to consumption
Other: Avocado
Fresh Avocado
Placebo Comparator: Ground Beef Patty without Avocado
Test burgers without fresh avocado added just prior to consumption
Other: No Avocado
No Avocado

Detailed Description:

The Hass Avocado contains monounsaturated fat, lutein, glutathione, vitamin E, and other antioxidants. This study will determine whether avocado exerts a beneficial effect by inhibition of the absorption of malondialdehyde (MDA) which is a measure of lipid peroxidation. In a previous study, we demonstrated that spice antioxidants resulted in a 70 percent decrease in the formation of MDA during cooking and that healthy volunteers consuming burgers made with spice excreted 50 percent less MDA in their urine than subjects consuming a control burger made without spices. Since the spices were added during cooking of the burger, it was not possible to assess the effects of the antioxidants in the stomach. Foods in the stomach continue to form lipid peroxidation products during digestion and this is called the "bioreactor" function of the stomach. In the proposed study known quantities of fresh avocado will be placed on top of a burger prior to consumption to determine whether the avocado inhibits formation of MDA from cooked burger meat in the stomach. Work by Aljada et al (42) demonstrated an increase in inflammatory and oxidative markers in mononuclear cells using Western blot analysis of NFkB and NADPH oxidase subunits following a mixed high calorie meal. Considering the rich content of bioactives compounds in the avocado, we therefore selected these methods for the endpoint determinations as well in this proposed randomized, crossover study.

We will accomplish the following specific aims:

  1. To measure plasma and urine malondialdehyde by HPLC before and over6 hours after consumption of the test burgers with or without fresh avocado added just prior to consumption.
  2. To measure insulin, glucose, triglycerides, TNF-α, IL-6, IL-8, NFκB activation, nitric oxide and peripheral arterial tonometry after each test burger.

These studies will add to the evidence that antioxidants in a lipid phase can inhibit formation and/or absorption of cytotoxic lipid products such as malondialdehyde. Ultimately, a better understanding of the role of bioactive substances from plant foods such as the avocado may demonstrate the importance of plant-based antioxidants in human health.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 - 35 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.

Exclusion Criteria:

  • Females
  • Abnormal liver function (AST and 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397071

Locations
United States, California
UCLA Center for Human Nutriiton
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: David Heber, MD, PhD UCLA Center for Human Nutrition
  More Information

No publications provided

Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01397071     History of Changes
Other Study ID Numbers: HAB-001
Study First Received: July 18, 2011
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Avocado, antioxidant

ClinicalTrials.gov processed this record on August 28, 2014