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Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05266183
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Jenny Craig, Inc.
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University

Brief 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.

Condition or disease Intervention/treatment Phase
Eating Behavior Other: Simultaneous Variety Other: Single-Food Other: Small Portion Other: Large Portion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women
Actual Study Start Date : March 7, 2022
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : September 6, 2022

Arm Intervention/treatment
Experimental: Simultaneous Variety, Small Portion
3 different foods served in a small portion.
Other: Simultaneous Variety
3 different foods served

Other: Small Portion
Small meal portion size

Experimental: Simultaneous Variety, Large Portion
3 different foods served in a large portion.
Other: Simultaneous Variety
3 different foods served

Other: Large Portion
Large meal portion size

Experimental: Single-Food, Small Portion
1 food served in a small portion.
Other: Single-Food
1 food served

Other: Small Portion
Small meal portion size

Experimental: Single-Food, Large Portion
1 food served in a large portion.
Other: Single-Food
1 food served

Other: Large Portion
Large meal portion size




Primary Outcome Measures :
  1. Change in intake by weight [ Time Frame: Weeks 1, 2, 3, 4 ]
    Weight (grams) of all meal components consumed

  2. Change in energy intake [ Time Frame: Weeks 1, 2, 3, 4 ]
    Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density


Secondary Outcome Measures :
  1. Change in bite count [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of bites of food during the meal

  2. Change in meal duration [ Time Frame: Weeks 1, 2, 3, 4 ]
    Duration of the meal in minutes

  3. Change in mean eating rate [ Time Frame: Weeks 1, 2, 3, 4 ]
    Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration

  4. Change in mean bite size [ Time Frame: Weeks 1, 2, 3, 4 ]
    Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count

  5. Change in sip count [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of sips of water during the meal

  6. Change in mean drinking rate [ Time Frame: Weeks 1, 2, 3, 4 ]
    Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration

  7. Change in mean sip size [ Time Frame: Weeks 1, 2, 3, 4 ]
    Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count

  8. Change in switching between bites and sips [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of switches between bites and sips during the meal

  9. Change in switching between different foods [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of switches between different foods

  10. Change in rating of pleasantness of the taste of food samples [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    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

  11. Change in rating of desire to eat food samples [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    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.

  12. Change in rating of hunger [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm)

  13. Change in rating of thirst [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm)

  14. Change in rating of nausea [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm)

  15. Change in rating of fullness [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm)

  16. Change in rating of prospective consumption [ Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4 ]
    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?".



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05266183


Contacts
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Contact: Cara Meehan 814-863-2877 cmt5070@psu.edu

Locations
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United States, Pennsylvania
Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Cara Meehan    814-863-2877    cmt5070@psu.edu   
Sponsors and Collaborators
Penn State University
Jenny Craig, Inc.
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Responsible Party: Barbara J. Rolls, Professor of Nutrition and Director of The Laboratory For The Study of Human Ingestive Behavior, Penn State University
ClinicalTrials.gov Identifier: NCT05266183    
Other Study ID Numbers: FoodVariety103
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No