Effects of Avocado Intake on the Nutritional Status of Families

Cardiovascular Disease Clinical Trial

Official title:

Effects of Avocado Intake on the Nutritional Status of Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903433
• Other study ID #: 160584
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: April 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• High-intake avocados
Families will receive 14 avocados on a weekly basis.
• Low-intake avocados
Families will receive 3 avocados on a weekly basis.

Behavioral:
• 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.
• Avocado consumption advice
Recipe book with healthy recipe suggestions that include avocado.

Locations

Country	Name	City	State
United States	South Bay Latino Research Center	Chula Vista	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	San Diego State University, San Ysidro Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in family energy consumption at 3 and 6 months		3 months and 6 months
Primary	Change in distribution of macro and micronutrient intake at 6 months		3 months and 6 months
Secondary	Change in cardio-metabolic risk factors by serum lipids at 6 months		3 months and 6 months
Secondary	Change in cardio-metabolic risk factors by insulin at 6 months		3 months and 6 months
Secondary	Change in cardio-metabolic risk factors by glucose at 6 months		3 months and 6 months
Secondary	Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months		3 months and 6 months
Secondary	Change in nutritional status by red blood cell fatty acid composition at 6 months		3 months and 6 months
Secondary	Change in nutritional status by red blood cell magnesium at 6 months		3 months and 6 months
Secondary	Change in nutritional status by serum total and fractionated carotenoids at 6 months		3 months and 6 months