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

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

Tracking Information

• First Submitted Date: February 23, 2022
• First Posted Date: March 4, 2022
• Last Update Posted Date: August 1, 2022
• Actual Study Start Date: March 7, 2022
• Estimated Primary Completion Date: August 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Eating Behavior

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 23, 2022): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 6, 2022
• Estimated Primary Completion Date: August 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05266183
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Barbara J. Rolls, Penn State University
• Original Responsible Party: Same as current
• Current Study Sponsor: Penn State University
• Original Study Sponsor: Same as current
• Collaborators: Jenny Craig, Inc.
• Investigators: Not Provided
• PRS Account: Penn State University
• Verification Date: July 2022