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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01397071
Enrollment
11
Registered
2011-07-19
Start date
2011-08-31
Completion date
2012-08-31
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Avocado, antioxidant

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.

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. Study demonstrated an increase in inflammatory and oxidative markers in mononuclear cells using Western blot analysis of nuclear factor-kappa light chain enhancer of activated B cells (NFkB) and NADPH oxidase subunits following a mixed high calorie meal. Considering the rich content of bioactive 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 high performance liquid chromatography 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, tumor necrosis factor alpha (TNF-α), interleukin 6 (IL-6), Interleukin 8 (IL-8), NFkB 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.

Interventions

OTHERAvocado

Fresh Avocado

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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 (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

Design outcomes

Primary

MeasureTime frameDescription
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)Baseline and 2 hours post-ingestionChange 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.

Secondary

MeasureTime frameDescription
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-ingestionChange from baseline inflammatory marker IkB-alpha in response to the consumption of 250 g beef patty with or without 68 g avocado added was assessed at 0 (baseline), 1, 2, 3, 4, 5, 6 hours post-ingestion. Baseline and 3 hours post-ingestion was reported.

Countries

United States

Participant flow

Recruitment details

The enrollment period was 8/2011 to 2/2012. Enrollment took place in a private setting in the clinic located at the site.

Pre-assignment details

17 healthy male volunteers were recruited and screened; 6 failed screen; 11 participants completed crossover study.

Participants by arm

ArmCount
Consumption of Beef Patty With or Without Avocado
Participants consumed 250 g cooked ground beef patty with or without 68 g fresh avocado added prior to ingestion.
11
Total11

Baseline characteristics

CharacteristicConsumption of Beef Patty With or Without Avocado
Age, Continuous25.4 years
STANDARD_DEVIATION 5.7
Race/Ethnicity, Customized
Asian
1 Participants
Race/Ethnicity, Customized
Black
2 Participants
Race/Ethnicity, Customized
Hispanic
4 Participants
Race/Ethnicity, Customized
White
4 Participants
Region of Enrollment
United States
11 participants
Sex/Gender, Customized
Male participants
11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 110 / 11
serious
Total, serious adverse events
0 / 110 / 11

Outcome results

Primary

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.

Time frame: Baseline and 2 hours post-ingestion

ArmMeasureGroupValue (MEAN)Dispersion
Participants Consumed 250 g Beef Patties AloneChange of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)PAT index before intervention2.20 score on a scaleStandard Deviation 0.36
Participants Consumed 250 g Beef Patties AloneChange of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)PAT index at 2 hr after intervention1.56 score on a scaleStandard Deviation 0.21
Participants Consumed 250 g Beef Patties With Avocado AddedChange of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)PAT index at 2 hr after intervention2.08 score on a scaleStandard Deviation 0.51
Participants Consumed 250 g Beef Patties With Avocado AddedChange of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)PAT index before intervention2.17 score on a scaleStandard Deviation 0.57
Comparison: Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestionp-value: 0.052t-test, 2 sided
Secondary

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

Change from baseline inflammatory marker IkB-alpha in response to the consumption of 250 g beef patty with or without 68 g avocado added was assessed at 0 (baseline), 1, 2, 3, 4, 5, 6 hours post-ingestion. Baseline and 3 hours post-ingestion was reported.

Time frame: 0 (baseline) and 3 hours post-ingestion

ArmMeasureGroupValue (MEAN)Dispersion
Participants Consumed 250 g Beef Patties AloneChange in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)IkB-alpha at baseline100 percentage of baselineStandard Deviation 0
Participants Consumed 250 g Beef Patties AloneChange in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)IkB-alpha 3 h after intervention57.8 percentage of baselineStandard Deviation 15
Participants Consumed 250 g Beef Patties With Avocado AddedChange in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)IkB-alpha at baseline100 percentage of baselineStandard Deviation 0
Participants Consumed 250 g Beef Patties With Avocado AddedChange in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)IkB-alpha 3 h after intervention131.3 percentage of baselineStandard Deviation 26.8
Comparison: Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.p-value: 0.03t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026