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Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults

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ClinicalTrials.gov Identifier: NCT02369588
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Barbara J. Rolls, Penn State University

Tracking Information
First Submitted Date  ICMJE February 17, 2015
First Posted Date  ICMJE February 24, 2015
Last Update Posted Date February 24, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2015)
  • Differences in meal food intake [ Time Frame: Weeks 1, 2, 3, and 4 ]
    Differences in weight of food consumed (grams) at the meals
  • Differences in meal energy intake [ Time Frame: Weeks 1, 2, 3, and 4 ]
    Differences in energy of food consumed (kilocalories) at the meals
  • Differences in meal energy density [ Time Frame: Weeks 1, 2, 3, and 4 ]
    Differences in energy density of food consumed (kilocalories per gram) at the meal
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2015)
  • Differences in hunger and satiety [ Time Frame: Weeks 1, 2, 3, and 4 ]
    Differences in ratings of hunger and satiety either before or after the meal, as assessed by 100-mm visual analog scales (mm)
  • Differences in ratings of food properties [ Time Frame: Weeks 1, 2, 3, and 4 ]
    Differences in ratings of food properties (such as taste or healthfulness) as assessed either by 100-mm visual analog scales (mm) or ranking (rank order)
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 Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults
Official Title  ICMJE Not Provided
Brief Summary This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density. The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Feeding Behaviors
Intervention  ICMJE Other: Food portion size
Study Arms  ICMJE
  • Experimental: 100% Portion Sizes
    Food portion size Test meal consists of baseline (100%) portion size of all foods
    Intervention: Other: Food portion size
  • Experimental: 133% Portion Sizes
    Food portion size Test meal consists of portion sizes of all foods that are 133% the size of baseline portions
    Intervention: Other: Food portion size
  • Experimental: 167% Portion Sizes
    Food portion size Test meal consists of portion sizes of all foods that are 167% the size of baseline portions
    Intervention: Other: Food portion size
  • Experimental: 200% Portion Sizes
    Food portion size Test meal consists of portion sizes of all foods that are 200% the size of baseline portions
    Intervention: Other: Food portion size
Publications * Roe LS, Kling SMR, Rolls BJ. What is eaten when all of the foods at a meal are served in large portions? Appetite. 2016 Apr 1;99:1-9. doi: 10.1016/j.appet.2016.01.001. Epub 2016 Jan 5.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2015)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index of 18 to 40 kg/square meter
  • Regularly eat three meals per day
  • Willing to eat foods served at test meals

Exclusion Criteria:

  • Food allergies or restrictions
  • Dieting to gain or lose weight
  • Taking medications known to affect appetite
  • Smoker
  • Athlete in training
  • Currently pregnant or breast-feeding
  • Questionnaire score indicative of depression
  • Questionnaire score indicative of disordered eating attitudes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (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 NCT02369588
Other Study ID Numbers  ICMJE PortionSize102
R01DK059853 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara J. Rolls, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Barbara J. Rolls The Pennsylvania State University
PRS Account Penn State University
Verification Date February 2015

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