Effects of Avocado Intake on the Nutritional Status of Families
2020年4月3日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
Specific Aim 1: To determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status:
- To determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet.
- To determine if avocado intake helps reduce between-meal snacking of family members.
- 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.
研究の種類
介入
入学 (実際)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Chula Vista、California、アメリカ、91910
- South Bay Latino Research Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
5年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Families will receive 14 avocados on a weekly basis.
Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.
Recipe book with healthy recipe suggestions that include avocado.
|
|
アクティブコンパレータ：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.
|
Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.
Recipe book with healthy recipe suggestions that include avocado.
Families will receive 3 avocados on a weekly basis.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in family energy consumption at 3 and 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
|
Change in distribution of macro and micronutrient intake at 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in cardio-metabolic risk factors by serum lipids at 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
|
Change in cardio-metabolic risk factors by insulin at 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
|
Change in cardio-metabolic risk factors by glucose at 6 months
時間枠：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
時間枠：3 months and 6 months
|
3 months and 6 months
|
|
Change in nutritional status by red blood cell fatty acid composition at 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
|
Change in nutritional status by red blood cell magnesium at 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
|
Change in nutritional status by serum total and fractionated carotenoids at 6 months
時間枠：3 months and 6 months
|
3 months and 6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Matthew A Allison, MD, MPH、University of California, San Diego
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年4月20日
一次修了 (実際)
2019年1月8日
研究の完了 (実際)
2019年1月8日
試験登録日
最初に提出
2016年9月2日
QC基準を満たした最初の提出物
2016年9月12日
最初の投稿 (見積もり)
2016年9月16日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月7日
QC基準を満たした最後の更新が送信されました
2020年4月3日
最終確認日
2020年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
循環器疾患の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
High-intake avocadosの臨床試験
-
Mentor Worldwide, LLC積極的、募集していない
-
SurgaColl Technologies Limitedわからない
-
University Hospital Inselspital, Berne募集緑内障 | 黄斑変性症 | ブドウ膜炎 | 糖尿病性網膜症 | 糖尿病性黄斑浮腫 | 黄斑浮腫 | 網膜静脈閉塞症 | 視神経疾患 | 網膜剥離 | 黄斑疾患 | 網膜疾患 | 網膜血管新生 | 網膜動脈閉塞症 | 高血圧性網膜症 | 網膜浮腫 | 網膜ジストロフィースイス
-
The Hong Kong Polytechnic UniversityYan Chai Hospital Social Services積極的、募集していない
-
University of California, San Francisco完了