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The Role of Emotional Arousal in Food Preference and Taste

Primary Purpose

Obesity, Food Craving, Food Consumption

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Imagery
Food Cue Imagery
Neutral-Relaxing
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring stress, food cues, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between ages 18-45 years
  • Able to read and write
  • Normal/lean BMI group: BMI 18.5-24.9 as calculated based on height and weight.
  • Overweight BMI group: BMI 25.0 - 29.9 as calculated based on height and weight Obese BMI group: BMI 30-35 as calculated based on height and weight.
  • Do not meet criteria for any current Axis I DSM-IV psychiatric diagnoses and provide negative urine toxicology screens during initial appointments and at admission for laboratory sessions.

Exclusion Criteria:

  • Meet current criteria for dependence on any psychoactive substance, including nicotine and caffeine
  • Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse
  • Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
  • Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded
  • Women on oral contraceptives, peri and post menopausal women, and those with hysterectomies
  • Pregnant and lactating women will be excluded.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Normal Weight

Overweight

Obese

Arm Description

BMI18.5-24.9 (normal range)

body mass index between 25.0 - 29.9 (overweight range)

body mass index between 30 and 35 (obese range)

Outcomes

Primary Outcome Measures

Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 5 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 15 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 30 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 45 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 60 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.

Secondary Outcome Measures

food snack intake
Food snacks are offered after each imagery condition and weighed for snack consumption.After each imagery period, subjects are presented with 3 bowls of highly palatable (chocolate pudding; potato chips, mini chocolate chip cookies) and 3 bowls of healthy food snacks (baby carrots; grapes), each portioned to ~500 calories (3000 calories per lab session).

Full Information

First Posted
January 30, 2014
Last Updated
February 10, 2022
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02402088
Brief Title
The Role of Emotional Arousal in Food Preference and Taste
Official Title
The Purpose of This Study is to Investigate the Role of Stress in Food Craving and Food Consumption by Examining Stress Response Using Subjective, Physiological and Neurobiological Measurements
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the role of stress in food craving and food consumption in obesity. Using experimentally validated guided imagery procedure, the investigators propose to examine the stress response using subjective, physiological and neurobiological measurements.
Detailed Description
One hundred and fifty men and women will participate in three laboratory sessions to assess stress responses to personal stress imagery, food cue imagery, and to neutral-relaxing imagery. Subjects will be distributed into 3 groups stratified by BMI category. Subject recruitment, eligibility determination, baseline assessments and script development will be conducted at the Yale Stress Center. Subjects will complete a variety of diagnostic, cognitive and psychological assessments, a comprehensive physical examination and blood work and will be involved in development of imagery scripts from personal stress, food cue and neutral-relaxing situations. Subjects will then be scheduled for three laboratory sessions at the Yale Stress Center. Subjects will also participate in an imagery and relaxation training session followed by three laboratory sessions. The three laboratory sessions will be conducted within a brief interval of days, when subjects will be exposed to a personal stress, a food cue and a neutral-relaxing imagery condition, one condition per day. The order of imagery conditions will be randomly assigned and counterbalanced across subjects in order to balance any influences due to order of imagery conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Food Craving, Food Consumption
Keywords
stress, food cues, obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Weight
Arm Type
Active Comparator
Arm Description
BMI18.5-24.9 (normal range)
Arm Title
Overweight
Arm Type
Experimental
Arm Description
body mass index between 25.0 - 29.9 (overweight range)
Arm Title
Obese
Arm Type
Experimental
Arm Description
body mass index between 30 and 35 (obese range)
Intervention Type
Behavioral
Intervention Name(s)
Stress Imagery
Intervention Description
The stress imagery script will be based on subjects' description of a recent personal stressful event that they had experienced as "most stressful". "Most stressful" is determined by having the subjects rate the perceived stress experienced by them on a 10-point Likert scale where "1=not at all stressful" and "10=the most stress they felt recently in their life". Only situations rated as 8 or above on this scale are accepted as appropriate for script development. Examples of acceptable stressful situations include breakup with significant other, a verbal argument with a significant other or family member or unemployment-related stress, such as being fired or laid off from work.
Intervention Type
Behavioral
Intervention Name(s)
Food Cue Imagery
Intervention Description
A food cue script will be developed from the subjects' experience of eating their most favorite foods. Examples include ordering pizza, cooking a favorite meal, or going out to a restaurant.
Intervention Type
Behavioral
Intervention Name(s)
Neutral-Relaxing
Intervention Description
A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.
Primary Outcome Measure Information:
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
Baseline
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
Immediately After Image
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory at plus 5 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
5 minutes
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory at plus 15 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
15 minutes
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory at plus 30 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
30 minutes
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory at plus 45 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
45 minutes
Title
Food Craving based on the Food Craving Inventory
Description
An abbreviated assessment base don the Food Craving Inventory at plus 60 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
food snack intake
Description
Food snacks are offered after each imagery condition and weighed for snack consumption.After each imagery period, subjects are presented with 3 bowls of highly palatable (chocolate pudding; potato chips, mini chocolate chip cookies) and 3 bowls of healthy food snacks (baby carrots; grapes), each portioned to ~500 calories (3000 calories per lab session).
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between ages 18-45 years Able to read and write Normal/lean BMI group: BMI 18.5-24.9 as calculated based on height and weight. Overweight BMI group: BMI 25.0 - 29.9 as calculated based on height and weight Obese BMI group: BMI 30-35 as calculated based on height and weight. Do not meet criteria for any current Axis I DSM-IV psychiatric diagnoses and provide negative urine toxicology screens during initial appointments and at admission for laboratory sessions. Exclusion Criteria: Meet current criteria for dependence on any psychoactive substance, including nicotine and caffeine Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded Women on oral contraceptives, peri and post menopausal women, and those with hysterectomies Pregnant and lactating women will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States

12. IPD Sharing Statement

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