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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02505230
Other study ID # UTK IRB-15-02349-XP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source The University of Tennessee, Knoxville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the energy consumed from an entree with high- or low-volume vegetables incorporated into the entree or served along side of the entree, in normal weight adults.


Description:

Participants will complete four experimental sessions, where a main entree with high- or-low volume vegetables (either added as a side item or mixed with the main entree) will be served for lunch, to determine the impact that presentation and liking may have on the consumption of energy dense foods. Once screened participants arrive for their first experimental session, they will record the foods and beverages they consumed in the past 24 hours, as well as write down the minutes of physical activity they participated in, within that same 24 hour period. The participants will rate their hunger, fullness, and liking of foods using a 100 mm VAS. After completing these forms, participants will be presented the appropriate meal, for their condition. Following the presentation of the meal, the participant will rate their liking of the meal appearance and then be instructed to eat as much or as little as they want of the meal provided in 20 minutes. At the completion of the allotted time, the meal will be removed, and the participant will evaluate their level of hunger, fullness, and liking of the foods consumed. The session will conclude with the collection of the hunger, fullness, and liking forms.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date December 31, 2024
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Body mass index (BMI) between 18.5 to 24.9 kg/m^2 - Unrestrained eater (<12 on Three Factor Eating Questionnaire [TFEQ]) - Report liking Fettucini Alfredo, zucchini, and squash (rate all items >50mm on a visual analogue scale [VAS]) - Report regularly eating before 10 am - Can compete all sessions within 8 weeks of the screening session Exclusion Criteria: - Report binge eating - Report a medical condition that influences eating - Report allergies to foods used in the investigation - Currently smoke - Report dietary restrictions - Report taking a medication that affects appetite - Report being pregnant or breast-feeding - Report being an athlete in training

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Eating
Participants will have 20 minutes to eat as much or as little of a meal (consisting of pasta alone or pasta with zucchini and squash presented in 3 different ways)

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 (5)

Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.

Rolls BJ, Drewnowski A, Ledikwe JH. Changing the energy density of the diet as a strategy for weight management. J Am Diet Assoc. 2005 May;105(5 Suppl 1):S98-103. doi: 10.1016/j.jada.2005.02.033. — View Citation

Rolls BJ, Meengs JS, Roe LS. Variations in cereal volume affect the amount selected and eaten for breakfast. J Acad Nutr Diet. 2014 Sep;114(9):1411-6. doi: 10.1016/j.jand.2014.01.014. Epub 2014 Mar 19. — View Citation

Rolls BJ. The relationship between dietary energy density and energy intake. Physiol Behav. 2009 Jul 14;97(5):609-15. doi: 10.1016/j.physbeh.2009.03.011. Epub 2009 Mar 20. — View Citation

Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Grams of main pasta entree consumed 20 minutes
Primary Grams of zucchini and squash consumed 20 minutes
Primary Level of hunger baseline
Primary Level of fullness baseline
Primary Level of liking baseline
Primary Energy intake 20 minutes
See also
  Status Clinical Trial Phase
Completed NCT01653886 - Palatability (Energy I Pilot) N/A
Completed NCT03394326 - Eat Healthy for Families N/A