NCT02481362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

June 23, 2015

Last Update Submit

April 3, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Order 1

ACTIVE COMPARATOR

Order for sessions: Cake, apricots

Other: CAKEOther: APRICOTS

Order 2

ACTIVE COMPARATOR

Order for sessions: apricots, Cake

Other: CAKEOther: APRICOTS

Interventions

CAKEOTHER

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

Order 1Order 2

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

Order 1Order 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (9)

  • 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.

    PMID: 19348547BACKGROUND
  • 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.

    PMID: 21593492BACKGROUND
  • 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.

    PMID: 17056408BACKGROUND
  • 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.

    PMID: 7824599BACKGROUND
  • 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.

    PMID: 25074389BACKGROUND
  • 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.

    PMID: 11850751BACKGROUND
  • 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.

    PMID: 24183146BACKGROUND
  • 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.

    PMID: 22684991BACKGROUND
  • 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.

    PMID: 9468749BACKGROUND

MeSH Terms

Conditions

Behavior, AddictiveFood PreferencesFeeding BehaviorSubstance-Related Disorders

Interventions

Prunus armeniaca extract

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorBehavior, AnimalChemically-Induced DisordersMental Disorders

Study Officials

  • Hollie Raynor, PhD

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 25, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations