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Effects of Avocado Intake on the Nutritional Status of Families

3. april 2020 opdateret af: Matthew Allison, University of California, San Diego
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Chula Vista, California, Forenede Stater, 91910
        • South Bay Latino Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: High-intake avocados
Families will receive 14 avocados on a weekly basis.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: Avocado consumption advice
Recipe book with healthy recipe suggestions that include avocado.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: Avocado consumption advice
Recipe book with healthy recipe suggestions that include avocado.
Andet: Low-intake avocados
Families will receive 3 avocados on a weekly basis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in family energy consumption at 3 and 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in distribution of macro and micronutrient intake at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Change in cardio-metabolic risk factors by serum lipids at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in cardio-metabolic risk factors by insulin at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in cardio-metabolic risk factors by glucose at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in nutritional status by red blood cell fatty acid composition at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in nutritional status by red blood cell magnesium at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months
Change in nutritional status by serum total and fractionated carotenoids at 6 months
Tidsramme: 3 months and 6 months
3 months and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Diego

Samarbejdspartnere

San Diego State University
San Ysidro Health Center

Efterforskere

  • Ledende efterforsker: Matthew A Allison, MD, MPH, University of California, San Diego

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. april 2017

Primær færdiggørelse (Faktiske)

8. januar 2019

Studieafslutning (Faktiske)

8. januar 2019

Datoer for studieregistrering

Først indsendt

2. september 2016

Først indsendt, der opfyldte QC-kriterier

12. september 2016

Først opslået (Skøn)

16. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 160584

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kardiovaskulær sygdom

Kliniske forsøg med High-intake avocados

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