Clinical trial NCT02903433: Effects of Avocado Intake on the Nutritional Status of Families
Official title: Effects of Avocado Intake on the Nutritional Status of Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Avocado
Cardiovascular disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: San Ysidro Health Center
First posted: 2016-09-16
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in family energy consumption at 3 and 6 months
timeFrame: 3 months and 6 months
measure: Change in distribution of macro and micronutrient intake at 6 months
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Change in cardio-metabolic risk factors by serum lipids at 6 months
timeFrame: 3 months and 6 months
measure: Change in cardio-metabolic risk factors by insulin at 6 months
timeFrame: 3 months and 6 months
measure: Change in cardio-metabolic risk factors by glucose at 6 months
timeFrame: 3 months and 6 months
measure: Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months
timeFrame: 3 months and 6 months
measure: Change in nutritional status by red blood cell fatty acid composition at 6 months
timeFrame: 3 months and 6 months
measure: Change in nutritional status by red blood cell magnesium at 6 months
timeFrame: 3 months and 6 months
measure: Change in nutritional status by serum total and fractionated carotenoids at 6 months
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: South Bay Latino Research Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Matthew A Allison, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: