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Cardiovascular DiseaseNCT02903433

Effects of Avocado Intake on the Nutritional Status of Families

A study testing High-intake avocados, Low-intake avocados and Diet tips in people with Cardiovascular Disease, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US). Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
High-intake avocados, Low-intake avocados and Diet tips
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
20 Apr 2017to 8 Jan 2019
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 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home
  • Self-identify as Latino or Hispanic
  • Be older than 5 years of age

Who cannot join

  • Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
  • Those allergic to avocados
  • Those with LATEX allergy
  • Families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day);
  • Those who are unwilling to eat avocados.
  • Family members with nursing or pregnant females or females planning to become pregnant
  • Family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados)
  • Families intending to move, or which include family members intending to move, within the next 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • South Bay Latino Research Center

    Chula Vista, California, 91910

Other trials in United States

About this study

Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US). The proposed research plan will focus on the contribution of avocado intake to the reduction in CVD risk of US families, by examining the effects of avocado intake on the overall nutritional status of families. Of particular interest is establishing these effects in ethnic populations such as Hispanics/Latinos. On average, Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD. This 6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families. Future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status.

Read the detailed description

Specific Aim 1: To determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status:

  1. To determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet.
  2. To determine if avocado intake helps reduce between-meal snacking of family members.
  3. To determine if avocados help families meet US Dietary Guidelines for recommended intake of: poly- and monounsaturated fats; vegetables; fiber; selected nutrients (vitamins C, D and E, Folate, Calcium, Magnesium, potassium, iron); lutein and other carotenoids.

Specific aim 2: To determine if increased avocado intake affects cardio-metabolic risk factors to include lipids, glucose, insulin, and HbA1c.

Being tested
High-intake avocados, Low-intake avocados, Diet tips, Avocado consumption advice
Keywords
Avocado, Cardiovascular disease
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intake avocadosOther

    Families will receive 14 avocados on a weekly basis.

  • Low-intake avocadosOther

    Families will receive 3 avocados on a weekly basis.

  • Diet tipsBehavioural

    Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.

  • Avocado consumption adviceBehavioural

    Recipe book with healthy recipe suggestions that include avocado.

Study groups in NCT02903433
Study groupRoleWhat they receive
High Intake GroupExperimentalThroughout the entire study, this group will be provided with 14 avocados per week and will receive 12 bi-weekly home visits over a 6-month period during which they will receive specific brochures offering "diet tips". This group will be given specific advice on avocado consumption. Each month throughout the study, we will provide opportunities for families to visit the study kitchen at the SYHC to observe the staff preparing recipes with avocado, participate in preparing recipes, and taste recipes.
Receives: Other: High-intake avocados; Behavioral: Diet tips; Behavioral: Avocado consumption advice
Low Intake GroupActive comparatorThis group will receive 3 avocados per week, as well as 12 bi-weekly home visits over a 6-month period during which they will be provided with the same educational materials (i.e., "Diet Tips") as those assigned to the "High intake" group. Participants in this group will be encouraged to improve the quality of their diets, but will not be given specific advice on avocado consumption. However, each month throughout the study, we will provide opportunities for families to visit the study kitchen at the SYHC to observe the staff preparing recipes with avocado, participate in preparing recipes, and taste recipes.
Receives: Other: Low-intake avocados; Behavioral: Diet tips; Behavioral: Avocado consumption advice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in family energy consumption at 3 and 6 months

    Measured: 3 months and 6 months

  2. Change in distribution of macro and micronutrient intake at 6 months

    Measured: 3 months and 6 months

Secondary outcomes (7)

  1. Change in cardio-metabolic risk factors by serum lipids at 6 months

    Measured: 3 months and 6 months

  2. Change in cardio-metabolic risk factors by insulin at 6 months

    Measured: 3 months and 6 months

  3. Change in cardio-metabolic risk factors by glucose at 6 months

    Measured: 3 months and 6 months

  4. Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months

    Measured: 3 months and 6 months

  5. Change in nutritional status by red blood cell fatty acid composition at 6 months

    Measured: 3 months and 6 months

  6. Change in nutritional status by red blood cell magnesium at 6 months

    Measured: 3 months and 6 months

  7. Change in nutritional status by serum total and fractionated carotenoids at 6 months

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2016 (estimated)
  2. Study start20 Apr 2017
  3. Primary completion8 Jan 2019
  4. Study completion8 Jan 2019

Resources

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
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02903433
Sponsor's protocol ID
160584
Status last verified
Apr 2020
First submitted
2 Sep 2016
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Allen TS, Doede AL, King CMB, Pacheco LS, Talavera GA, Denenberg JO, Eastman AS, Criqui MH, Allison MA. Nutritional Avocado Intervention Improves Physical Activity Measures in Hispanic/Latino Families: A Cluster RCT. AJPM Focus. 2023 Sep 20;2(4):100145. doi: 10.1016/j.focus.2023.100145. eCollection 2023 Dec.

    PubMed 37941823

  • VanEvery H, Pacheco LS, Sun E, Allison MA, Gao X. The impact of avocado intake on anthropometric measures among Hispanic/Latino children and adolescents: A cluster randomized controlled trial. Clin Nutr ESPEN. 2023 Aug;56:94-103. doi: 10.1016/j.clnesp.2023.04.020. Epub 2023 May 3.

    PubMed 37344091

Questions about this trial

What is this clinical trial studying?

A study testing High-intake avocados, Low-intake avocados and Diet tips in people with Cardiovascular Disease, run by University of California, San Diego 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 3 inclusion and 8 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 7 Apr 2020. 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 family energy consumption at 3 and 6 months (time frame: 3 months and 6 months). The study lists 2 primary outcomes in all. 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 NCT02903433, which also lists 2 linked publications.

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 7 Apr 2020.

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