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临床试验/NCT03278392
NCT03278392已完成不适用

Prenatal Emotion-Diet Interactions and the Metabolic Response

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task

研究概览

简要总结

This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.

详细描述

The purpose of this research study is to understand how a mother's emotional state in pregnancy influences her biological response to food intake. Natural variation in emotional and mental state is frequently experienced in daily life, including during pregnancy. While the investigators understand that a healthy diet is important in pregnancy for maintaining blood sugar levels and other metabolic factors within normal ranges for optimal development of the baby, less consideration is given to the health effects of a mother's mental state during pregnancy. It may even be possible that, regardless of what a woman eats or drinks, the way her body responds to food may differ according to her emotional or mental state.

This research is particularly interested in understanding how the combination of maternal emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to test whether and how an individual's emotional response to a mental challenge of varying complexity during pregnancy modifies the body's metabolic response to a standard breakfast.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • •Age 18-40 years
  • •Hispanic ethnicity
  • •English and/or Spanish speaking
  • •Multiparous
  • •28-30 week's gestation
  • •Pre-pregnancy BMI 25.0-34.9 kg/m2
  • •Singleton, intrauterine pregnancy
  • •Non-smoker
  • •Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)

排除标准

  • •BMI <25.0 or ≥35.0 kg/m2
  • •>30 week's gestation
  • •multiple pregnancy
  • •nulliparous
  • •present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)
  • •current smoker
  • •current psychiatric disorders or undergoing treatment/taking psychiatric medications
  • •Use of systemic/frequent corticosteroids or thyroid meds
  • •Diabetic or presence of other metabolic or neuroendocrine disorders

研究组 & 干预措施

Psychosocial challenge task

Experimental

Participants will be assigned to complete the Trier Social Stress Test (TSST) immediately after consuming a standardized breakfast drink

干预措施: Trier Social Stress Test (Behavioral)

Placebo challenge task

Sham Comparator

Participants will be assigned to complete the placebo non-stress task immediately after consuming a standardized breakfast drink

干预措施: Placebo Non-stress task (Behavioral)

结局指标

主要结局

Difference in the glycemic response to the standardized meal +/- psychosocial challenge task

时间窗: 2 hours

Glycemic response (area-under-the-curve of glucose) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.

次要结局

  • Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task(2 hours)
  • Physiological stress response to the psychosocial challenge task(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Lindsay

Principal Investigator

University of California, Irvine

研究点 (1)

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