Guac & Grow: Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Gut microbiome
研究概览
简要总结
The goal of this clinical trial is to learn if daily avocado intake can improve growth and brain and gut health in infants. The main questions it aims to answer are:
Does daily eating of avocados change which microbes live in the infant's gut? Does daily avocado intake improve infant motor skills and cognitive development?
Researchers will compare avocado intake to standard of care (no or limited avocado intake) to see if regular avocado intake from 6-12 months of life influences gut and brain health.
Participating mothers/guardians and their infants will:
Parents will provide avocado or no avocado to their infant every day for 6 months starting around 6 months of infant age.
Parents will allow study staff to visit participant homes to collect data via surveys and observations and measure infant growth.
Parents will swab soiled infant diapers for gut microbe measures. Parents will keep a diary of the infant's avocado consumption and acceptance of the food.
Parents will record their infant's dietary intake
详细描述
The overarching goal of this two-arm, randomized clinical trial, is to study how early avocado exposure impacts the gut microbiome and developmental milestones in Hispanic infants. The following aims will be achieved using a randomized, parallel-arm, clinical trial.
Specific Aim 1: Evaluate how avocado consumption modulates the infant GM. Hypothesis 1: Daily avocado exposure will produce distinct structural and functional signatures within the GM compared to control.
Specific Aim 2: Investigate how avocado consumption affects emerging motor and neurocognitive skills in infants.
Hypothesis 2: Daily avocado exposure will improve development compared to the control group.
All measures will be completed at participant homes when infants are 6, 9, and 12 months of age. Infants in the intervention arm will receive a daily amount of avocado and the amount consumed will be measured. Those in the control arm will be asked to limit avocado exposure to no more than once per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4-6-month-old Hispanic/Latine, non-preterm (>37 weeks gestation) singleton infants
- •Infants born to mothers 18 years and older while pregnant
- •Parents speak English and/or Spanish
- •Families willing to begin feeding infants avocado around 6 months of age or when the infant is ready for solids for a total of 6 months
- •Family history of food or latex allergies will be evaluated as avocado is a latex fruit and can cause allergic responses. If either mom or dad is allergic to avocado, physician clearance for infant participation will be needed.
- •At least one caregiver in the home must have at least an 8th-grade education level
排除标准
- •Infants with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development
- •Infants born with congenital abnormalities or developmental delays
- •Infant birth weights <2500 g or >4000 g
- •Infants introduced to solid foods prior to 3 months of age
- •Biological mothers with known substance use during pregnancy (alcohol, tobacco, marijuana, or illegal drugs), or who experienced a high-risk pregnancy (e.g., preeclampsia, diabetes-Types 1 and 2 and gestational, HIV, etc.)
研究组 & 干预措施
Daily Avocado
Infants in the daily avocado group will receive a daily exposure amount of avocado ranging from 1/4 (~37.5 g or 1.25 oz) to 1/2 (~75 g or 2.5 oz) of a medium-sized avocado.
干预措施: Daily avocado (Other)
No Avocado Control
Infants in the control group will be asked to limit avocado exposure to no more than 1/8 of a medium-sized avocado (~19 g, 2 Tbs) once per week.
结局指标
主要结局
Gut microbiome
时间窗: At enrollment to the end of treatment at 6 months
Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers.
次要结局
- Vineland Adaptive Behavior Scale (Vinland-3)(From enrollment to the end of treatment at 6 months)
- McArthur Bates Communicative Development Inventories III (MBCDI-III)(From enrollment to the end of treatment at 6 months)
- HOME Assessment(From enrollment to the end of treatment at 6 months)
- Mullen Scales of Early Learning(From enrollment to the end of treatment at 6 months)
- Infant length(From enrollment to the end of treatment at 6 months)
- Infant weight(From enrollment to the end of treatment at 6 months)
研究者
Corrie Whisner
Associate Professor
Arizona State University