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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02481362
Other study ID # UTK IRB-15-02330-XP
Secondary ID
Status Completed
Phase N/A
First received June 23, 2015
Last updated April 3, 2018
Start date June 2015
Est. completion date May 2016

Study information

Verified date April 2018
Source The University of Tennessee, Knoxville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine differences in habituation to foods high in sugar and fat content versus those that are not, in normal weight women.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

Other:
CAKE
For the CAKE condition, participants will play a computer task to earn points for cake that they can consume.
APRICOTS
For the APRICOTS condition, participants will play a computer task to earn points for apricots that they can consume.

Locations

Country Name City State
United States Healthy Eating and Activity Laboratory, University of Tennessee Knoxville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
The University of Tennessee, Knoxville

Country where clinical trial is conducted

United States, 

References & Publications (9)

Deglaire A, Méjean 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-Santé study). Eur J Clin Nutr. 2015 Jan;69(1):40-6. doi: 10.1038/ejcn.2014.139. Epub 2014 Jul 30. — View Citation

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. — View Citation

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. Review. — View Citation

Franko DL, Wolfe BE, Jimerson DC. Elevated sweet taste pleasantness ratings in bulimia nervosa. Physiol Behav. 1994 Nov;56(5):969-73. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Nov 28. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Grams of consumption of cake 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
Primary Grams of consumption of apricots 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
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