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Addictive BehaviorNCT02481362

Food Choices in Healthy Weight Women

A study testing CAKE and APRICOTS in people with Addictive Behavior and Food Preferences, run by The University of Tennessee, Knoxville at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Addictive Behavior, Food Preferences, Food Habits
What is being tested?
CAKE and APRICOTS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Jun 2015to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • on medications that may influence appetite
  • planning on changing diet or physical activity during time frame of the study
  • dieting
  • trying to lose weight

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Healthy Eating and Activity Laboratory, University of Tennessee

    Knoxville, Tennessee, 37996

Other trials in United States

About this study

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

Read the 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.

Being tested
CAKE, APRICOTS
Medical subject headings
Behavior, Addictive, Food Preferences, Feeding Behavior, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAKEOther

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

  • APRICOTSOther

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

Study groups in NCT02481362
Study groupRoleWhat they receive
Order 1Active comparatorOrder for sessions: Cake, apricots
Receives: Other: CAKE; Other: APRICOTS
Order 2Active comparatorOrder for sessions: apricots, Cake
Receives: Other: CAKE; Other: APRICOTS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 60 minutes

  2. 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).

    Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02481362
Sponsor's protocol ID
UTK IRB-15-02330-XP
Status last verified
Apr 2018
First submitted
23 Jun 2015
Last updated
5 Apr 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 19348547

  • 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.

    PubMed 21593492

  • 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.

    PubMed 17056408

  • 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.

    PubMed 7824599

  • 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.

    PubMed 25074389

  • 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.

    PubMed 11850751

  • 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.

    PubMed 24183146

  • 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.

    PubMed 22684991

  • 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.

    PubMed 9468749

Questions about this trial

What is this clinical trial studying?

A study testing CAKE and APRICOTS in people with Addictive Behavior and Food Preferences, run by The University of Tennessee, Knoxville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grams of consumption of cake (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02481362, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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