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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03502096
Other study ID # PortionSize105
Secondary ID R01DK059853NIFA
Status Completed
Phase N/A
First received April 3, 2018
Last updated April 10, 2018
Start date October 2016
Est. completion date December 2017

Study information

Verified date April 2018
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated whether the provision of a to-go container influenced the portion size effect at a meal. Following a screening visit, women came to the lab once a week for 4 weeks to eat a meal of multiple foods. At each visit, the portion size of the meal was varied in a counterbalanced order. Prior to their first meal, women were randomly assigned to one of two groups: a group that would have their leftovers packaged to go (to-go group) and a group that did not have leftovers packaged (control group). Women were instructed to eat ad libitum at the meals. They also answered questions about hunger and fullness as well as food characteristics before and after each meal. Following the final meal, subjects completed a series of questionnaires assessing subject characteristics as well as food characteristics. It was hypothesized that the effect of portion size on intake would be attenuated in subjects who received a to-go container with the meal. In addition, we aimed to identify any subject characteristics that moderated or exacerbated the portion size effect. It was also of interest to determine whether the portion size effect on individual foods were influenced by food characteristics such as perceived value.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Regularly eats 3 meals/day

- Willing to avoid alcohol the day before and during test days

- Likes foods offered at test meals

- Body mass index 18 - 36 (kg/m*m)

Exclusion Criteria:

- Smokes

- Athlete in training

- Pregnant or breastfeeding

- Taking medication that may affect appetite or food intake

- Food allergies or dietary restrictions

- Currently have or recently been diagnosed with disease or disorder known to affect appetite

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
To-Go container
Subjects were provided a to-go container in which leftover foods would be packaged
Other:
Control
Subjects were not provided a to-go container with the meal

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Penn State University Jenny Craig, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), United States Department of Agriculture (USDA)

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the weight of food consumed Change in the weight of food consumed (in grams) across experimental conditions and intervention groups. Weeks 1, 2, 3, and 4
Primary Change in energy intake Change in energy intake (in kcal) across experimental conditions and intervention groups. Weeks 1, 2, 3, and 4
Secondary Change in energy density consumed Change in food energy density consumed (in kcal/g) across experimental conditions and intervention groups. Weeks 1, 2, 3, and 4
Secondary Change in intake of individual foods Change in both the weight (g) and energy (kcal) consumed of individual foods served at the meal across experimental conditions and intervention groups. Weeks 1, 2, 3, and 4
Secondary Changes in post-meal measures of satiety Changes in post-meal measures of satiety across experimental conditions and intervention groups using 100-mm visual analog scales. Weeks 1, 2, 3, and 4
Secondary Changes in post-meal ratings of meal characteristics Changes in post-meal ratings of meal characteristics across experimental conditions and between subject groups using 100-mm visual analog scales. Weeks 1, 2, 3, and 4
Secondary Changes in ratings of food properties Changes in post-meal ratings of food properties across experimental conditions and subject groups using 100-mm visual analog scales. Weeks 1, 2, 3, and 4
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