- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02481362
Food Choices in Healthy Weight Women
Study Overview
Status
Intervention / Treatment
Detailed Description
Participants will complete two experimental sessions, in which habituation to chocolate cake and dried apricots will be measured, with each session measuring habituation rate to one food. Upon arrival to the session, participants will write down what they have consumed and the minutes of physical activity they have engaged in during the previous 24 hours. Participants will rate their feelings of hunger and fullness using a 100mm VAS. They will also rank their liking of the food being used in the session using a 100mm VAS. Participants will be given a peanut butter flavored granola bar, containing 190 kcal, and be instructed to consume all of the bar.
Next, participants will complete a computer generated task to measure habituation to a food (chocolate cake or apricots). The computer task will be programmed at a variable interval of 120 ± 42 seconds (VI-120) reinforcement schedule, so that participants will be rewarded one point for the first response made after approximately 120s have passed. The computer task consists of two squares, one that flashes red every time a mouse button is pressed and another square that flashes green when a point is earned. The habituation phase will be 24 minutes, divided into 12, 2-minute trials, during which participants can earn points towards access to 75 kcal portions of the food that is being measured. Participants will receive the food immediately after each point is earned to consume and can continue to play the computer task while eating. Participants will be instructed that when they no longer want to earn access to the food they can go to another table and engage in the activities provided (i.e., reading magazines). After the computer task, participants will rate their feeling of hunger, fullness, and liking of the food. During the computer task the number of consecutive two-minute time blocks before responding ceases, as well as the overall pattern of responding, will be measured.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996
- Healthy Eating and Activity Laboratory, University of Tennessee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- body mass index (BMI) 18.5 to 24.9 kg/m2
- nonsmokers
- not allergic to the foods used in the investigation
- must like the foods in the investigation (scoring > 50 mm on a visual analogue scale [VAS])
- be willing to consume the foods
- not have dietary restrictions
- not be a restrained eater (scoring > 12 on the Three Factor Eating Scale)
- not be on medications that influence appetite
- not planning to change their diet or physical activity during the time frame of their study participation
- not dieting or trying to lose weight.
Exclusion Criteria:
- BMI outside of the range 18.5-24.9
- smoker
- food allergies
- does not like the foods used in the study
- has dietary restrictions
- is a restrained eater
- on medications that may influence appetite
- planning on changing diet or physical activity during time frame of the study
- dieting
- trying to lose weight
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Order 1
Order for sessions: Cake, apricots
|
For the CAKE condition, participants will play a computer task to earn points for cake that they can consume.
For the APRICOTS condition, participants will play a computer task to earn points for apricots that they can consume.
|
ACTIVE_COMPARATOR: Order 2
Order for sessions: apricots, Cake
|
For the CAKE condition, participants will play a computer task to earn points for cake that they can consume.
For the APRICOTS condition, participants will play a computer task to earn points for apricots that they can consume.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grams of consumption of cake
Time Frame: 60 minutes
|
Amount of cake consumed will be measured using the following formula: amount of cake before consumption (first weight) - amount of cake following consumption (second weight).
|
60 minutes
|
Grams of consumption of apricots
Time Frame: 60 minutes
|
Amount of apricots consumed will be measured using the following formula: amount of apricots before consumption (first weight) - amount of apricots following consumption (second weight).
|
60 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hollie Raynor, PhD, University of Tennessee, Knoxville
Publications and helpful links
General Publications
- Epstein LH, Temple JL, Roemmich JN, Bouton ME. Habituation as a determinant of human food intake. Psychol Rev. 2009 Apr;116(2):384-407. doi: 10.1037/a0015074.
- Epstein LH, Carr KA, Cavanaugh MD, Paluch RA, Bouton ME. Long-term habituation to food in obese and nonobese women. Am J Clin Nutr. 2011 Aug;94(2):371-6. doi: 10.3945/ajcn.110.009035. Epub 2011 May 18.
- Goldfield GS, Legg C. Dietary restraint, anxiety, and the relative reinforcing value of snack food in non-obese women. Eat Behav. 2006 Nov;7(4):323-32. doi: 10.1016/j.eatbeh.2005.11.006. Epub 2005 Nov 28.
- Franko DL, Wolfe BE, Jimerson DC. Elevated sweet taste pleasantness ratings in bulimia nervosa. Physiol Behav. 1994 Nov;56(5):969-73. doi: 10.1016/0031-9384(94)90331-x.
- Deglaire A, Mejean C, Castetbon K, Kesse-Guyot E, Hercberg S, Schlich P. Associations between weight status and liking scores for sweet, salt and fat according to the gender in adults (The Nutrinet-Sante study). Eur J Clin Nutr. 2015 Jan;69(1):40-6. doi: 10.1038/ejcn.2014.139. Epub 2014 Jul 30.
- McGloin AF, Livingstone MB, Greene LC, Webb SE, Gibson JM, Jebb SA, Cole TJ, Coward WA, Wright A, Prentice AM. Energy and fat intake in obese and lean children at varying risk of obesity. Int J Obes Relat Metab Disord. 2002 Feb;26(2):200-7. doi: 10.1038/sj.ijo.0801883.
- Gearhardt AN, Roberto CA, Seamans MJ, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale for children. Eat Behav. 2013 Dec;14(4):508-12. doi: 10.1016/j.eatbeh.2013.07.002. Epub 2013 Jul 21. Erratum In: Eat Behav. 2014 Apr;15(2):334.
- Gearhardt AN, White MA, Masheb RM, Morgan PT, Crosby RD, Grilo CM. An examination of the food addiction construct in obese patients with binge eating disorder. Int J Eat Disord. 2012 Jul;45(5):657-63. doi: 10.1002/eat.20957. Epub 2011 Aug 30.
- Ridgway PS, Jeffrey DB. A comparison of the Three-Factor Eating Questionnaire and the Restraint Scale and consideration of Lowe's Three-Factor Model. Addict Behav. 1998 Jan-Feb;23(1):115-8. doi: 10.1016/s0306-4603(97)00031-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTK IRB-15-02330-XP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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