NCT03409601

Brief Summary

The study uses a crossover design in which the portion size of food is varied at each meal. Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights. The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food. Test meals will be scheduled once a week for four weeks. At visits 2-5, subjects will eat lunch and rate characteristics of the meal. At visit 6, subjects will complete various questionnaires. The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

January 18, 2018

Last Update Submit

March 14, 2019

Conditions

Feeding Behavior

Keywords

Obesity, eating behavior, food, nutrition

Outcome Measures

Primary Outcomes (2)

  • Differences in energy intake

    Calculated energy intake (kcal) based on weight and energy density of food consumed

    Weeks 1, 2, 3, and 4

  • Differences in intake by weight

    Weights (grams) of all foods consumed

    Weeks 1, 2, 3, and 4

Secondary Outcomes (5)

  • Sensory-specific satiety

    Weeks 1, 2, 3, and 4

  • Eating rate

    Weeks 1, 2, 3, and 4

  • Ratings of hunger and satiety

    Weeks 1, 2, 3, and 4

  • Ratings of sensory characteristics of the food

    Weeks 1, 2, 3, and 4

  • Ratings of meal characteristics

    Weeks 1, 2, 3, and 4

Study Arms (4)

100% Portion Size

EXPERIMENTAL

Test meal consists of baseline (100%) portion size of meal.

Other: 100% Portion Size

125% Portion Size

EXPERIMENTAL

Test meal consists of food portion size that is 125% the size of baseline portion.

Other: 125% Portion Size

150% Portion Size

EXPERIMENTAL

Test meal consists of food portion size that is 150% the size of baseline portion.

Other: 150% Portion Size

175% Portion Size

EXPERIMENTAL

Test meal consists of food portion size that is 175% the size of baseline portion.

Other: 175% Portion Size

Interventions

100% Portion SizeOTHER

Meal portion size at baseline

100% Portion Size
125% Portion SizeOTHER

Meal portion size 125% of baseline

125% Portion Size
150% Portion SizeOTHER

Meal portion size 150% of baseline

150% Portion Size
175% Portion SizeOTHER

Meal portion size 175% of baseline

175% Portion Size

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing and able to travel to Penn State University Park campus weekly for meals
  • Be a man or woman 18 - 60 years old
  • Regularly eat 3 meals/day
  • Be willing to avoid alcohol the day before and during test days
  • Have a body mass index between 18.0 and 35.0 kg/m-squared
  • Be willing to refrain from eating after 10 pm the evening before test sessions

You may not qualify if:

  • A smoker
  • An athlete in training
  • Pregnant or breastfeeding at the time of screening
  • Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
  • Dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
  • Currently dieting to gain or lose weight
  • Have a health condition that affects appetite
  • Have participated in a similar study in our lab in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Feeding BehaviorObesity

Interventions

Portion Size

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BJR

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

April 2, 2018

Primary Completion

December 14, 2018

Study Completion

December 14, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)