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临床试验/NCT01552759
NCT01552759已完成不适用

Appetite Hormones in Binge Eating Disorder

New York Obesity and Nutrition Research Center1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2007年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test

研究概览

简要总结

This study investigates the hormones that the body produces in response to food intake and in response to stress, and the way that stress influences food intake. In particular, it compares the hormone levels and food intake of people with and without binge eating disorder. In order to find out how these appetite- and stress-related hormones are linked to brain activity, the study also includes an fMRI scan, a non-invasive procedure that looks at which regions of the brain are most active during a food-related scenario.

详细描述

The objectives are to study appetite-related hormones regulating food intake under normal conditions and following a stressor in the morning and evening (when most binge episodes occur), to help reveal biological mechanisms in BED. We plan to enroll: 32 obese Ss with BED (16m, 16f), 32 obese Ss without BED (16m, 16f) and 32 normal-weight Ss without BED (16m, 16f). Height, weight, waist circumference, and body fat will be assessed during a first appointment. On two different days separated by at least a week, Ss will ingest a fixed liquid meal once in the morning and once in the evening. Appetite ratings and collections of blood and saliva to measure hormones will continue for 2 hours after the fixed meal. This will be followed on each day by a laboratory stress protocol (Socially Evaluated Cold Pressor Test; SECPT), and then consumption of an ad libitum meal 30 minutes later. On one day during the protocol, the participant will collect saliva using a swab immediately after waking and again at 08.00. In order to capture more naturalistic eating episodes, all Ss will additionally record food intake, rate appetite, and measure salivary cortisol before and after one evening meal, and one after-dinner snack (or after-dinner binge for BED Ss). On two additional days, we will use fMRI to assess brain activation in response to high-palatability food (HPF) relative to low-palatability food (LPF) or non-food (NF) visual cues following the SECPT and a control condition using warm water. On each day, following the fMRI scan, an ad libitum meal will be consumed.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI of 20-25 or 30-50
  • stable weight(± 4%) for at least 3 mo
  • premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
  • must like pizza and be willing to consume it during the ad libitum meal

排除标准

  • significant medical or psychiatric conditions
  • current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (> 3 drinks/d)
  • vigorously exercise for more than 6 h/wk
  • left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment

结局指标

主要结局

Appetite-related Hormones and Appetite Ratings in Relation to Fixed Meal and Cold Pressor Test

时间窗: Assessed at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00

Blood and saliva concentrations of hormones influencing appetite will be measured at systematic intervals (-15, 0, 10, 30, 60, 90, 120 min) before and after the morning fixed meal at 10.00 and the evening fixed meal at 17.00. Appetite will additionally be rated at each assessment point. This will be followed by a cold pressor test, and then 30 min later by an ad libitum meal 30 min later, with blood and saliva measurements taken before and after completion of the meal.

次要结局

  • Cortisol Awakening response(Assessed on one weekday morning during the 3-week participation period)
  • Psychological Scales(During one initial consultation and on two subsequent visits at least 1 week apart)
  • Body Weight, Body Composition and Gender(During one initial consultation and on two subsequent visits at least 1 week apart)

研究者

发起方
New York Obesity and Nutrition Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Allan Geliebter

Principal Investigator

New York Obesity and Nutrition Research Center

研究点 (1)

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