Effects of Avocado Intake on the Nutritional Status of Families

NCT ID: NCT02903433

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2019-01-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High Intake Group

Throughout 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.

Group Type EXPERIMENTAL

High-intake avocados

Intervention Type OTHER

Families will receive 14 avocados on a weekly basis.

Diet tips

Intervention Type BEHAVIORAL

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 advice

Intervention Type BEHAVIORAL

Recipe book with healthy recipe suggestions that include avocado.

Low Intake Group

This 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.

Group Type ACTIVE_COMPARATOR

Low-intake avocados

Intervention Type OTHER

Families will receive 3 avocados on a weekly basis.

Diet tips

Intervention Type BEHAVIORAL

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 advice

Intervention Type BEHAVIORAL

Recipe book with healthy recipe suggestions that include avocado.

Interventions

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High-intake avocados

Families will receive 14 avocados on a weekly basis.

Intervention Type OTHER

Low-intake avocados

Families will receive 3 avocados on a weekly basis.

Intervention Type OTHER

Diet tips

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

Intervention Type BEHAVIORAL

Avocado consumption advice

Recipe book with healthy recipe suggestions that include avocado.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
2. Those allergic to avocados
3. Those with LATEX allergy
4. 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);
5. Those who are unwilling to eat avocados.
6. Family members with nursing or pregnant females or females planning to become pregnant
7. 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)
8. Families intending to move, or which include family members intending to move, within the next 6 months
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role collaborator

San Ysidro Health Center

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Matthew Allison

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew A Allison, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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South Bay Latino Research Center

Chula Vista, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37941823 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37344091 (View on PubMed)

Other Identifiers

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160584

Identifier Type: -

Identifier Source: org_study_id

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