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临床试验/NCT06208085
NCT06208085招募中不适用

An Avocado Intervention to Increase the Nutrients in Human Milk in Support of Infant Cognitive Development

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
88
试验地点
2
主要终点
Recognition Memory in an Oddball Task

研究概览

简要总结

The goal of this interventional study is to establish a whole food, avocado, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. Eighty-eight breastfeeding dyads, 3m postnatal, will participate in this study designed to:

  1. To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks.
  2. To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado.
  3. To measure the cognitive advantage conferred to infants whose mothers consume avocados while breastfeeding compared to a non-avocado-eating reference group.

To this end, healthy, lactating women who are 13 weeks postpartum and their infants will be enrolled. Mothers will be provided avocados on a bi-weekly basis and will be asked to consume an avocado a day. Infant cognition will be tested when the infants are 4.5 and 6 months of age. Milk samples and diet data will be collected and assayed on a bi-weekly basis.

详细描述

Nutrients do not appear in nature alone with some appearing together more often than not. It is reasonable to posit that nutrients are working together, and thus, the synergies among the nutrients are important to understand. First, choline is integral to brain fatty acids in that phosphatidylcholine (PC) serves an active role in mediating hepatic export of fatty acids to extra-hepatic tissues such as brain: fatty acids are stored in the liver, and PC moves them to the brain. Erythrocyte PC-DHA is integral to our consideration of a potential mechanism behind our results. Enriched in docosahexaenoic acid (DHA), PC comprises the cell membrane and influences membrane fluidity with downstream effects on signal transduction thereby improving speed of processing and recognition memory. Lutein has a very important role also in that it is known to co-localize with DHA specifically resulting in improvements in visual acuity, for example, and in general, it has been shown to protect fatty acids from peroxidation. Indeed, interventions with avocado have shown a significant increase in plasma lutein and a decrease in lipid peroxidation. It is hypothesized that lutein is also having this effect in the brain. As work with single nutrient supplementation does not yield strong cognitive effects, the investigators study the effects of co-occurring nutrients on cognitive development. The proposed study is designed to achieve an overall objective of establishing a whole food, avocado, as a viable study material in the pursuit of optimization of human milk with nutrients that support brain development. The long-term goal is to establish guidelines for maternal nutrition during gestation and lactation that include key nutrients for fetal and infant brain development, and the overall impact of this research program will be to set children on a trajectory for school readiness. The central hypothesis is that maternal avocado consumption will provide nutrients through human milk to support the development and function of neural substrates that support cognition. Specifically, choline, lutein, and fatty acids will work synergistically to improve brain function.

Mothers will be randomized to avocado or no avocado (due to lack of an appropriate control food). Participants will come to the lab 3 times across 6 months (enrollment/3months, 4.5 months, and 6 months). Milk sample will be provided every two weeks and will be picked up from the participants. At pickup, the avocado group will also be provided a new supply of avocados. Diet data will be collected at each visit/pickup (every two weeks). The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 and 6 months. Saliva samples will also be collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy lactating women at 13 weeks postpartum
  • Planning to exclusively breastfeed to 6 months of age
  • Gave birth at 38 weeks or greater gestation without remarkable incident
  • Pre-pregnancy BMI <30

排除标准

  • Gestational diabetes
  • Infant with diagnosis or documented suspicion of developmental delay
  • Any documented seizure activity in infant
  • Family history of avocado, latex, or banana allergies

研究组 & 干预措施

No Avocado

No Intervention

Comparison arm in which no intervention occurs.

Avocado

Experimental

Participants will be provided avocados and asked to consume an avocado a day for 12 weeks.

干预措施: Avocado (Dietary Supplement)

结局指标

主要结局

Recognition Memory in an Oddball Task

时间窗: Week 12 (at 6 months of age)

The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the avocado group will have better memory for the familiar pictures than the no avocado group.

Change in Choline Content of Milk

时间窗: Baseline, Week 12

Human milk will be assayed for choline every two weeks and analyzed for change over time (7 data points across 12 weeks).

Change in Lutein Content of Milk

时间窗: Baseline, Week 12

Human milk will be assayed for lutein every two weeks and analyzed for change over time (7 data points across 12 weeks).

Change in Fatty Acid Content of Milk

时间窗: Baseline, Week 12

Human milk will be assayed for fatty acids every two weeks and analyzed for change over time (7 data points across 12 weeks).

次要结局

  • Bayley Scales of Infant Development (BSID)(Week 6 (at 4.5 months of age))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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