Focus: Avocado Consumption & Vascular HealthNCT01595607
The Effect of Avocado Consumption on Vascular Health
A study testing Diet Treatment in people with Focus: Avocado Consumption & Vascular Health, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The study will investigate the effect of avocado consumption on markers of vascular health. Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be utilized. Read more about this study
- Who is it for?
- Ages 28 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Avocado Consumption & Vascular Health
- What is being tested?
- Diet Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25 and 42 kg/m2
- Age 28 to 70 years during the intervention
- Fasting glucose ≤ 126 mg/dl
- Blood pressure ≤ 160/100 mm Hg
Who cannot join
- Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
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- Volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
- Volunteers who have lost 10% of body weight within the last 12 months
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity
- Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
- Smokers or other tobacco users (during the 6 months prior to the start of the study)
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion.)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: The Influence of Daily Consumption of Avocado on Biomarkers of Vascular Health
The study will investigate the effect of avocado consumption on markers of vascular health. Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be utilized. Participants will either receive a typical American diet, or a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat, to allow the isoenergetic inclusion of avocado.
- Being tested
- Diet Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet TreatmentOther
Participants will consume a controlled diet for 6 weeks where all meals will be provided by the facility. Participants will be instructed to eat all foods and only foods provided to them.
| Study group | Role | What they receive |
|---|---|---|
| Typical American Diet | Active comparator | Participants will receive a typical American diet for 6 weeks. Receives: Other: Diet Treatment |
| Avocado Diet | Experimental | Participants will receive a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat to allow the inclusion of avocado. Receives: Other: Diet Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Function
Noninvasive endothelial function will be assessed, following a 12-hours fast, by measuring endothelium-dependent flow mediated dilation of the peripheral bed. Participants will then consume a test meal and endothelial function will be assessed again 3 hours later.
Measured: 0 hr and 3 hr at baseline and after 6 weeks
Secondary outcomes (3)
Change in Blood Pressure
Blood pressure will be measured using a standardized protocol at the beginning and end of the intervention.
Measured: Baseline and after 6 weeks
Change in Gene Expression
Blood samples will be used to test how the intervention affects gene expression. The expression of genes related to cardiovascular disease risk will be measured at the beginning and end of the 6-week intervention (fasted and post-prandially).
Measured: Baseline and after 6 weeks
Change in Biomarkers of Cardiovascular Disease Risk
Blood will be collected at the beginning and end of the dietary intervention, following the endothelial function measurements (fasted and post-prandial collections). Blood will be assessed for biomarkers of cardiovascular disease risk, including electrolytes (sodium, potassium, chloride), markers of inflammation (IL-6, IL-10, IL-1 beta, C-reactive protein, TNF-alpha, fibrinogen, ICAM), markers of vascular function (endothelin-1, factor VII, plasminogen), and blood lipid panel (plasma total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides).
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Avocado Consumption & Vascular HealthStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Hass Avocado Board
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595607
- Sponsor's protocol ID
- HS39
- Status last verified
- Feb 2016
- First submitted
- 7 Feb 2012
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Daily Consumption of Avocado on Biomarkers of Vascular Health
- ClinicalTrials.gov ID
- NCT01595607
- Acronym / sponsor ID
- HS39
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Collaborators
- Hass Avocado Board
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate the effect of avocado consumption on markers of vascular health. Sixty participants will be enrolled in the 6-week study. A randomized parallel design will be utilized. Participants will either receive a typical American diet, or a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat, to allow the isoenergetic inclusion of avocado.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical American Diet | Active comparator | Other: Diet TreatmentParticipants will receive a typical American diet for 6 weeks. |
| Avocado Diet | Experimental | Other: Diet TreatmentParticipants will receive a modified typical American diet in which avocado is substituted for foods that contain moderate and high amounts of saturated fat to allow the inclusion of avocado. |
Who may qualify
- Ages
- 28 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 25 and 42 kg/m2
- Age 28 to 70 years during the intervention
- Fasting glucose ≤ 126 mg/dl
- Blood pressure ≤ 160/100 mm Hg
Key exclusion criteria (14 listed)
- Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
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 |
|---|---|---|
| Diet TreatmentParticipants will consume a controlled diet for 6 weeks where all meals will be provided by the facility. Participants will be instructed to eat all foods and only foods provided to them. | Other | Avocado Diet, Typical American Diet |
Primary outcome
Change in Endothelial Function
Time frame: 0 hr and 3 hr at baseline and after 6 weeks
Noninvasive endothelial function will be assessed, following a 12-hours fast, by measuring endothelium-dependent flow mediated dilation of the peripheral bed. Participants will then consume a test meal and endothelial function will be assessed again 3 hours later.
3 secondary outcomes
Change in Blood Pressure
Time frame: Baseline and after 6 weeks
Change in Gene Expression
Time frame: Baseline and after 6 weeks
Change in Biomarkers of Cardiovascular Disease Risk
Time frame: Baseline and after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Treatment in people with Focus: Avocado Consumption & Vascular Health, run by USDA Beltsville Human Nutrition Research Center 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 4 inclusion and 14 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 24 Feb 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Endothelial Function (time frame: 0 hr and 3 hr at baseline and after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2016.