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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03886428
Other study ID # PortionSize106
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2019
Est. completion date December 13, 2019

Study information

Verified date March 2020
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to gain a better understanding of the satiation measures that influence human eating behavior in regard to intake of large portion sizes at a meal. The investigators hypothesize that satiation measures will influence the magnitude of the portion size effect at a meal. Additionally, other individual characteristics will be examined for their influence on the portion size effect. The portion size effect will be measured by serving a test meal once a week for four weeks in which the portion size of the entree will be varied.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 13, 2019
Est. primary completion date December 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Be willing and able to travel to Penn State University Park campus weekly for meals

- Be a man or woman 18 - 70 years old

- Regularly eat 3 meals/day

- Be willing to avoid alcohol the day before and during test days

- Have a body mass index between 18.0 and 35.0 kg/m*m

- Be willing to refrain from eating after 10 pm the evening before test sessions

- Be willing to participate in all study procedures

Exclusion Criteria:

- Must not be a smoker

- Must not be an athlete in training

- Must not be pregnant or breastfeeding at the time of screening

- Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months

- Dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)

- Must not be currently dieting to gain or lose weight

- Have a health condition that affects appetite

- Have participated in a similar study in our lab in the past year

- Must not be a student, faculty, or staff member in nutritional sciences or psychology

Study Design


Related Conditions & MeSH terms


Intervention

Other:
100% portion size
Entree portion size 100% of baseline
125% portion size
Entree portion size 125% of baseline
150% portion size
Entree portion size 150% of baseline
175% portion size
Entree portion size 175% of baseline

Locations

Country Name City State
United States The Pennsylvania State University University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University Jenny Craig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Rating of the size of the entree compared to participants' usual portion 100-point visual analog scale ranging from a lot smaller to a lot larger At the start of the test meal in weeks 1, 2, 3, 4
Other Rating of how filling participants expect this amount of food to be 100-point visual analog scale ranging from not at all filling to extremely filling At the start of the test meal in weeks 1, 2, 3, 4
Other Rating of pleasantness of taste of entree 100-point visual analog scale ranging from not pleasant at all to extremely pleasant At the start of the test meal in weeks 1, 2, 3, 4
Other Ratings of Meal Termination due to fullness 100-point visual analog scale ranging from strongly disagree to strongly agree At the end of the test meal in weeks 1, 2, 3, 4
Other Ratings of Meal Termination due to eating their usual amount 100-point visual analog scale ranging from strongly disagree to strongly agree At the end of the test meal in weeks 1, 2, 3, 4
Other Ratings of Meal Termination due to eating is no longer a priority 100-point visual analog scale ranging from strongly disagree to strongly agree At the end of the test meal in weeks 1, 2, 3, 4
Other Ratings of Meal Termination due to there being no food left 100-point visual analog scale ranging from strongly disagree to strongly agree At the end of the test meal in weeks 1, 2, 3, 4
Other Ratings of Meal Termination due to self-consciousness about amount consumed 100-point visual analog scale ranging from strongly disagree to strongly agree At the end of the test meal in weeks 1, 2, 3, 4
Other Ratings of Meal Termination due to the food no longer tasting good 100-point visual analog scale ranging from strongly disagree to strongly agree At the end of the test meal in weeks 1, 2, 3, 4
Other Rating of proportion of meal eaten 100-point visual analog scale ranging from 0% to 100% At the end of the test meal in weeks 1, 2, 3, 4
Other Rating of calories consumed at the meal Open ended question At the end of the test meal in weeks 1, 2, 3, 4
Primary Change in energy intake Calculated energy intake (kcal) based on weight and energy density of food consumed Weeks 1, 2, 3, 4
Primary Change in intake by weight Weights (grams) of all foods consumed Weeks 1, 2, 3, 4
Secondary Change in bite count The number of bites of the entree during the meal Weeks 1, 2, 3, 4
Secondary Change in meal duration Duration of the meal in seconds Weeks 1, 2, 3, 4
Secondary Change in mean bite rate Assessed from meal duration (seconds) and number of bites taken Weeks 1, 2, 3, 4
Secondary Change in mean bite size Assessed from entree intake (grams) and number of bites Weeks 1, 2, 3, 4
Secondary Change in mean eating rate Assessed from entree intake (grams) and meal duration Weeks 1, 2, 3, 4
Secondary Change in distribution of estimated bite size Assessed as small or large bites from video observation Weeks 1, 2, 3, 4
Secondary Change in sip count The number of sips of the water during the meal Weeks 1, 2, 3, 4
Secondary Change in rating of the pleasantness of the taste of the entree sample Measured on a 100-mm visual analogue scale ranging from not at all pleasant (0 mm) to extremely pleasant (100 mm). This will be used to calculate Sensory-Specific Satiety From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in rating of the pleasantness of the taste of food samples Measured on a 100-mm visual analogue scale ranging from not at all pleasant (0 mm) to extremely pleasant (100 mm). This will be used to calculate Sensory-Specific Satiety From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in rating of prospective consumption of the entree sample Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) in answer to the question 'How much of the pasta do you want to eat right now?'. This will be used to calculate Sensory-Specific Satiety From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in rating of prospective consumption of food samples Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) how much of the [this food] do you want to eat right now?. This will be used to calculate Sensory-Specific Satiety From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in rating of hunger Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in rating of thirst Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in ratings of prospective consumption Measured on a 100-mm visual analogue scale ranging from nothing at all (0 mm) to a large amount (100 mm) in answer to the question 'How much food could you eat right now?'. From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in ratings of nausea Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4
Secondary Change in rating of fullness Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4
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