Food Choices in Healthy Weight Women
Primary Purpose
Addictive Behavior, Food Preferences, Food Habits
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAKE
APRICOTS
Sponsored by
About this trial
This is an interventional basic science trial for Addictive Behavior
Eligibility Criteria
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
Sites / Locations
- Healthy Eating and Activity Laboratory, University of Tennessee
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Order 1
Order 2
Arm Description
Order for sessions: Cake, apricots
Order for sessions: apricots, Cake
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02481362
First Posted
June 23, 2015
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT02481362
Brief Title
Food Choices in Healthy Weight Women
Official Title
Food Choices in Healthy Weight Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addictive Behavior, Food Preferences, Food Habits, Healthy, Habituation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Order 1
Arm Type
Active Comparator
Arm Description
Order for sessions: Cake, apricots
Arm Title
Order 2
Arm Type
Active Comparator
Arm Description
Order for sessions: apricots, Cake
Intervention Type
Other
Intervention Name(s)
CAKE
Intervention Description
For the CAKE condition, participants will play a computer task to earn points for cake that they can consume.
Intervention Type
Other
Intervention Name(s)
APRICOTS
Intervention Description
For the APRICOTS condition, participants will play a computer task to earn points for apricots that they can consume.
Primary Outcome Measure Information:
Title
Grams of consumption of cake
Description
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).
Time Frame
60 minutes
Title
Grams of consumption of apricots
Description
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).
Time Frame
60 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie Raynor, PhD
Organizational Affiliation
University of Tennessee, Knoxville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Eating and Activity Laboratory, University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19348547
Citation
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Results Reference
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PubMed Identifier
21593492
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.
Results Reference
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PubMed Identifier
17056408
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. doi: 10.1016/j.eatbeh.2005.11.006. Epub 2005 Nov 28.
Results Reference
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PubMed Identifier
7824599
Citation
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.
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PubMed Identifier
25074389
Citation
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Results Reference
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PubMed Identifier
11850751
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. doi: 10.1038/sj.ijo.0801883.
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
22684991
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.
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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. doi: 10.1016/s0306-4603(97)00031-2.
Results Reference
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Food Choices in Healthy Weight Women
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