Healthy VolunteersNCT01397071
Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men
A study testing Avocado in people with Healthy Volunteers, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Avocado
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Participation in a therapeutic research study within 30 days of baseline
- Consumption of vegetarian diet
- Allergy or sensitivity to dairy products
- Allergic to avocado
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutriiton
Los Angeles, California, 90095
About this study
Official title: Hass Avocado Flesh Inhibition of Appearance of Lipid Peroxidation Products When Added to a Ground Beef Patty Consumed by Healthy Volunteers
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.
Read the 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:
- 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.
- 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.
- Conditions
- Healthy Volunteers
- Being tested
- Avocado
- Keywords
- Avocado, antioxidant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvocadoOther
Fresh Avocado
| Study group | Role | What they receive |
|---|---|---|
| Ground Beef Patty with Avocado | Active comparator | Test burgers with fresh avocado added just prior to consumption Receives: Other: Avocado |
| Ground Beef Patty without Avocado | Active comparator | Test burgers Receives: Other: Avocado |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 0 (baseline) and 3 hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- David Heber, MD, PhD, Principal investigator, UCLA Center for Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397071
- Sponsor's protocol ID
- HAB-001
- Status last verified
- Sep 2019
- First submitted
- 18 Jul 2011
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23196671
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hass Avocado Flesh Inhibition of Appearance of Lipid Peroxidation Products When Added to a Ground Beef Patty Consumed by Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01397071
- Acronym / sponsor ID
- HAB-001
- Conditions
- Healthy Volunteers
- Keywords
- Avocado, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ground Beef Patty with Avocado | Active comparator | Other: AvocadoTest burgers with fresh avocado added just prior to consumption |
| Ground Beef Patty without Avocado | Active comparator | Other: AvocadoTest burgers |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvocadoFresh Avocado | Other | Ground Beef Patty with Avocado, Ground Beef Patty without Avocado |
Primary outcome
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)
Time frame: Baseline and 2 hours post-ingestion
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.
1 secondary outcome
Change in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)
Time frame: 0 (baseline) and 3 hours post-ingestion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23196671Li 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.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Heber, MD, PhD principal investigator
UCLA Center for Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avocado in people with Healthy Volunteers, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) (time frame: Baseline and 2 hours post-ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01397071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.