Clinical trial NCT02402088: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Food Craving
Food Consumption
Keywords: stress
food cues
obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-03-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Food Craving based on the Food Craving Inventory
timeFrame: Baseline
measure: Food Craving based on the Food Craving Inventory
timeFrame: Immediately After Image
measure: Food Craving based on the Food Craving Inventory
timeFrame: 5 minutes
measure: Food Craving based on the Food Craving Inventory
timeFrame: 15 minutes
measure: Food Craving based on the Food Craving Inventory
timeFrame: 30 minutes
measure: Food Craving based on the Food Craving Inventory
timeFrame: 45 minutes
measure: Food Craving based on the Food Craving Inventory
timeFrame: 60 minutes
Secondary outcomes:
measure: food snack intake
timeFrame: 30 minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Professor
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: