The Role of Emotional Arousal in Food Preference and Taste

NCT ID: NCT02402088

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Obesity Food Craving Food Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Normal Weight

BMI18.5-24.9 (normal range)

Group Type ACTIVE_COMPARATOR

Stress Imagery

Intervention Type BEHAVIORAL

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.

Food Cue Imagery

Intervention Type BEHAVIORAL

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.

Neutral-Relaxing

Intervention Type BEHAVIORAL

A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.

Overweight

body mass index between 25.0 - 29.9 (overweight range)

Group Type EXPERIMENTAL

Stress Imagery

Intervention Type BEHAVIORAL

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.

Food Cue Imagery

Intervention Type BEHAVIORAL

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.

Neutral-Relaxing

Intervention Type BEHAVIORAL

A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.

Obese

body mass index between 30 and 35 (obese range)

Group Type EXPERIMENTAL

Stress Imagery

Intervention Type BEHAVIORAL

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.

Food Cue Imagery

Intervention Type BEHAVIORAL

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.

Neutral-Relaxing

Intervention Type BEHAVIORAL

A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.

Interventions

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Stress Imagery

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

Food Cue Imagery

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

Neutral-Relaxing

A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajita Sinha, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK099039-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0801003403

Identifier Type: -

Identifier Source: org_study_id

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