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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05266183
Other study ID # FoodVariety103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date September 21, 2022

Study information

Verified date October 2022
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to investigate the combined effects of simultaneous meal variety and portion size on food intake at a meal. Additionally, other individual characteristics will be examined for their influence on the effects of simultaneous variety and portion size on meal intake.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Be willing and able to travel to Penn State University Park campus weekly for meals - Be fully vaccinated against COVID-19 - Be a woman 20 - 65 years old - Regularly eat 3 meals/day - Be willing to refrain from drinking 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 - Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months - Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions) - Must not have a high variability in liking of the test foods - Must not be currently dieting to gain or lose weight - Must not have a health condition that affects appetite - Must not 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:
Simultaneous Variety
3 different foods served
Single-Food
1 food served
Small Portion
Small meal portion size
Large Portion
Large meal portion size

Locations

Country Name City State
United States Laboratory for the Study of Human Ingestive Behavior, 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
Primary Change in intake by weight Weight (grams) of all meal components consumed Weeks 1, 2, 3, 4
Primary Change in energy intake Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density Weeks 1, 2, 3, 4
Secondary Change in bite count The number of bites of food during the meal Weeks 1, 2, 3, 4
Secondary Change in meal duration Duration of the meal in minutes Weeks 1, 2, 3, 4
Secondary Change in mean eating rate Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration Weeks 1, 2, 3, 4
Secondary Change in mean bite size Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count Weeks 1, 2, 3, 4
Secondary Change in sip count The number of sips of water during the meal Weeks 1, 2, 3, 4
Secondary Change in mean drinking rate Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration Weeks 1, 2, 3, 4
Secondary Change in mean sip size Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count Weeks 1, 2, 3, 4
Secondary Change in switching between bites and sips The number of switches between bites and sips during the meal Weeks 1, 2, 3, 4
Secondary Change in switching between different foods The number of switches between different foods Weeks 1, 2, 3, 4
Secondary Change in rating of 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 desire to eat food samples Measured on a 100-mm visual analogue scale ranging from not at all strong (0 mm) to extremely strong (100 mm), in answer to "How strong is your desire to eat [this food] 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 rating 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
Secondary Change in rating 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 "How much food do you think you could eat right now?". From before the test meal to after the test meal in weeks 1, 2, 3, 4
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