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Food Addiction and Hormone Study

2016年10月18日更新者：Cynthia Dsauza、Texas Tech University

Food Addition and Hormone Study

The purpose of this exploratory study is to use Electrogastrography (EGG) to measure and compare the gastric myoelectrical activity between persons with food addiction (FA) and a control group. Additionally, this study will explore if differences exist between perceived hunger and satiety and hormone levels related to hunger and satiety in both groups. The comparison of the EGG readings and hormone levels is the next step in furthering our understanding of food addiction and how the physiology - not simply the symptomatology - of FA does or does not relate to weight management.

研究概览

地位

未知

条件

饮食失调

详细说明

The study will be conducted over 2 days and will consist of psychological assessments as well as EGG measurement (similar to EGG) and blood draws to examine hunger and satiety hormones.

研究类型

观察性的

注册 (预期的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Texas
  - Lubbock、Texas、美国、79409
    - 招聘中
    - TTU College of Human Sciences
    - 接触：
      
      Allison Childress
      
      电话号码：806-834-6371
      
      邮箱：allison.childress@ttu.edu
    - 接触：
      
      Cynthia Dsauza
      
      电话号码：8067437335

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

men and women 18-65 who are able to come to TTU for testing and meet eligibility criteria

描述

Inclusion Criteria:

Participants will include men and women who identify with weight struggles related to disordered eating and a control sample of people who do not identify with weight issues or disordered eating. Must be able to read and write English

Exclusion Criteria:

Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
Anyone who is currently pregnant, or lactating
Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling- e.g. antibiotics, anti-depressants, obesity medications
Report of medical condition or surgical intervention that affects swallowing ability
Allergy, aversion, or dislike to any of the meal replacements or snacks offered
Previous or current diagnosis of a psychiatric illness such as schizophrenia or any other psychotic disorder listed in the DSM-IV or DSM-5
Report of medical conditions that prohibits overnight fasting

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Food Addiction Group Those participants identified as having food addiction by the Yale Food Addiction Scale.
No Food Addiction Group Those participants with no identified food addiction

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Electrogastrography (EGG) using Bipoac Systems EGG machine 大体时间：the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC	Skin electrode similar to EKG attached to abdomen and readings taken	the participant will be tested continuously for approximately 3 1/2 hours on 1 day, readings are collected on a PC

次要结果测量

结果测量	措施说明	大体时间
Ghrelin 大体时间：collected via IV catheter over approximately 3 1/2 hours on one day	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day
Peptide YY 大体时间：collected via IV catheter over approximately 3 1/2 hours on one day	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day
GLP-1 大体时间：collected via IV catheter over approximately 3 1/2 hours on one day	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day
Insulin 大体时间：collected via IV catheter over approximately 3 1/2 hours on one day	hormone assay	collected via IV catheter over approximately 3 1/2 hours on one day
Glucose 大体时间：collected via IV catheter over approximately 3 1/2 hours on one day	Blood glucose levels	collected via IV catheter over approximately 3 1/2 hours on one day
The Center for Epidemiologic Studies Depression Scale 大体时间：Day 1-5-10 minutes	Depression will be measured using The Center for Epidemiologic Studies Depression Scale Revised , a 20-item measure of depression that measures nine different symptom groups of depression according to the American Psychiatric Association Diagnostic and Statistical Manual, fourth edition. These symptom groups include Sadness, Loss of Interest, Appetite, Sleep, Thinking/Concentration, Guilt, Tired, Movement, and Suicidal Ideation. Responses regard frequency of symptoms and are given on 5-point Likert-type scale ranging from 0 (Not at all or less than one day) to 4 (Nearly every day for two weeks). Sample items include "My appetite was poor" and "Nothing made me happy." Item responses are summed to calculate a total score of depression that can be used to classify depression severity. This assessment will take approximately 5-10 minutes.	Day 1-5-10 minutes
GAD-7 大体时间：Day 1 5-10 minutes	Anxiety will be measured using the GAD-7 measure used to assess for generalized anxiety disorder and will take less than 5 minutes to complete. The GAD-7 measures anxiety using seven items to assess frequency of anxiety symptoms on which responses are given on a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (Nearly every day). Sample items include "Feeling anxious, nervous, or on edge" and "Becoming easily annoyed or irritable." All items are summed; and higher scores represent higher levels of anxiety and can be used to classify anxiety severity.	Day 1 5-10 minutes
Yale Food Addiction Scale 2.0 大体时间：Day 1 5-10 minutes	The YFAS is a 35-item measure developed to operationalize food addiction by assessing signs of substance-dependence symptoms (e.g., tolerance, withdrawal, loss of control) in eating behavior. The YFAS has shown internal consistency, as well as convergent and incremental validity. The YFAS provides 2 scoring options: a symptom count version and a diagnostic version. To receive a "diagnosis" of FA, it is necessary to report experiencing 3 or more symptoms in the past year and clinically significant impairment or distress. The version of the YFAS used in the current study will measure all items on a Likert scale. In line with YFAS scoring instructions, 5 of the Likert scale items were dichotomized, such that participants who indicated that they had never experienced the symptom were assigned a value of zero, and those reporting ever experiencing the symptom in the past year were assigned a value of 1.	Day 1 5-10 minutes
Power of Food Scale 大体时间：Day 1 5-10 minutes	The Power of Food Scale (PFS) is a 15-item questionnaire on a 5-point Likert scale ranging from 1 (don't agree) to 5 (strongly agree), and it is designed to measure appetite drive towards highly palatable foods through examining appetite-related thoughts, feelings, and motivations	Day 1 5-10 minutes
Multidimensional Body-Self Relations Questionnaire - Appearance Scales 大体时间：Day 1 5-10 minutes	The Multidimensional Body-Self Relations Questionnaire - Appearance Scales (MBSRQ-AS) is a 34 item measure on a five point Likert scale that is made up of five subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale.	Day 1 5-10 minutes
Trait and State Food Cravings Questionnaires 大体时间：Day 1 5-10 minutes	The Trait and State Food Cravings Questionnaire is comprised of two questionnaires that measure state (FCQ-S) and trait (FCQ-T) of food cravings. The FCQ-S is comprised of 15 items, and the FCQ-T is comprised of 21 items.	Day 1 5-10 minutes
Food Preoccupation Questionnaire 大体时间：Day 1 5-10 minutes	The Food Preoccupation Questionnaire (FPQ) is a 26 Likert item questionnaire that measures the frequency and emotionality of thoughts related to food. It is comprised of four subscales: thought frequency as well as positive, negative, and neutral emotional valences.	Day 1 5-10 minutes
Automated Self-Administered (ASA) 24 Hour Recall 大体时间：Day 1 5-10 minutes	The Automated Self-Administered 24 hour Dietary Recall is a web-based tool that enables automated self-administered 24-hour recalls. It was developed by the National Cancer Institute and has been used in over 200 research studies with over 45,000 participants. Response data are secured at the hosting site using industry standard security controls, including firewalls and encryption.	Day 1 5-10 minutes
Resting Metabolic Rate 大体时间：10 min	participant breathes into mouthpiece of handheld device for 10 minutes	10 min

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Texas Tech University

调查人员

首席研究员：Cynthia Dsauza, PhD、Assistant Professor

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年8月1日

初级完成 (预期的)

2016年11月1日

研究完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2015年12月3日

首先提交符合 QC 标准的

2015年12月17日

首次发布 (估计)

2015年12月23日

研究记录更新

最后更新发布 (估计)

2016年10月19日

上次提交的符合 QC 标准的更新

2016年10月18日

最后验证

2016年10月1日