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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05266183
Recruitment Status : Active, not recruiting
First Posted : March 4, 2022
Last Update Posted : August 1, 2022
Sponsor:
Collaborator:
Jenny Craig, Inc.
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University

Tracking Information
First Submitted Date  ICMJE February 23, 2022
First Posted Date  ICMJE March 4, 2022
Last Update Posted Date August 1, 2022
Actual Study Start Date  ICMJE March 7, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • Change in intake by weight [ Time Frame: Weeks 1, 2, 3, 4 ]
    Weight (grams) of all meal components consumed
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2022)
  • Change in bite count [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of bites of food during the meal
  • Change in meal duration [ Time Frame: Weeks 1, 2, 3, 4 ]
    Duration of the meal in minutes
  • 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
  • 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
  • Change in sip count [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of sips of water during the meal
  • 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
  • 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
  • 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
  • Change in switching between different foods [ Time Frame: Weeks 1, 2, 3, 4 ]
    The number of switches between different foods
  • 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
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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?".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women
Official Title  ICMJE Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Eating Behavior
Intervention  ICMJE
  • Other: Simultaneous Variety
    3 different foods served
  • Other: Single-Food
    1 food served
  • Other: Small Portion
    Small meal portion size
  • Other: Large Portion
    Large meal portion size
Study Arms  ICMJE
  • Experimental: Simultaneous Variety, Small Portion
    3 different foods served in a small portion.
    Interventions:
    • Other: Simultaneous Variety
    • Other: Small Portion
  • Experimental: Simultaneous Variety, Large Portion
    3 different foods served in a large portion.
    Interventions:
    • Other: Simultaneous Variety
    • Other: Large Portion
  • Experimental: Single-Food, Small Portion
    1 food served in a small portion.
    Interventions:
    • Other: Single-Food
    • Other: Small Portion
  • Experimental: Single-Food, Large Portion
    1 food served in a large portion.
    Interventions:
    • Other: Single-Food
    • Other: Large Portion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2022)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 6, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05266183
Other Study ID Numbers  ICMJE FoodVariety103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Barbara J. Rolls, Penn State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Penn State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Jenny Craig, Inc.
Investigators  ICMJE Not Provided
PRS Account Penn State University
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP