- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663214
The Combined Effects of Energy Density and Variety on Intake (VarxED)
June 17, 2026 updated by: Cornell University
The primary purpose of this study is to investigate the influence independent fn combined influence of variety and energy density on food intake at a meal.
Additionally, individual characteristics will be examined for their influence on the effects of variety and energy density on intake.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paige M Cunningham, PhD
- Phone Number: 607-255-2650
- Email: pmc242@cornell.edu
Study Locations
-
-
New York
-
Ithaca, New York, United States, 14850
- Cornell University
-
Contact:
- Paige M Cunningham, PhD
- Phone Number: 607-255-2650
- Email: pmc242@cornell.edu
-
Principal Investigator:
- Paige M Cunningham, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Regularly consume 3 meals per day
- Like, are willing to eat, and do not have allergies to the study foods
- Are willing to refrain from drinking alcohol the day before study visits
- Are willing to consume a consistent breakfast the day of study visits
- Have a BMI between 18.5-29.9 kg/m2
Exclusion Criteria:
- Experienced a weight change >5 kg in the past month
- Are a smoker
- Are an athlete in training
- Take medications or have a health condition known to affect appetite
- Are pregnant or breastfeeding
- Have ever been diagnosed with an eating disorder or depression
- Specialize in the fields of psychology or nutritional sciences.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low variety, Low ED
One low energy dense food served
|
Only one food served
Foods are low in energy density
|
|
Experimental: Low variety, High ED
One high energy dense foods served
|
Only one food served
Foods are high in energy density
|
|
Experimental: High variety, Low ED
Three low energy dense foods served
|
Foods are low in energy density
Three foods served
|
|
Experimental: High variety, High ED
Three high energy dense foods served
|
Foods are high in energy density
Three foods served
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in food intake
Time Frame: Weeks 1, 2, 3, 4
|
Weight (grams) of the food consumed
|
Weeks 1, 2, 3, 4
|
|
Change in energy intake
Time Frame: Weeks 1, 2, 3, 4
|
Energy (kcal) of the food consumed
|
Weeks 1, 2, 3, 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in bite count
Time Frame: Weeks 1, 2, 3, 4
|
The number of bites of food during the meal
|
Weeks 1, 2, 3, 4
|
|
Change in sip count
Time Frame: Weeks 1, 2, 3, 4
|
The number of sips of water during the meal
|
Weeks 1, 2, 3, 4
|
|
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
|
Weeks 1, 2, 3, 4
|
|
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)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
|
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)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
|
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)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
|
Change in meal duration
Time Frame: Weeks 1, 2, 3, 4
|
Duration of the meal in minutes
|
Weeks 1, 2, 3, 4
|
|
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.
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
|
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)
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
|
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?".
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
|
Change in water intake
Time Frame: Weeks 1, 2, 3, 4
|
Weight (grams) of water consumed
|
Weeks 1, 2, 3, 4
|
|
Change in 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
|
Weeks 1, 2, 3, 4
|
|
Change in bite size
Time Frame: Weeks 1, 2, 3, 4
|
Mean grams of food consumed per bite, calculated by dividing meal food intake by number of bites.
|
Weeks 1, 2, 3, 4
|
|
Change in rating of liking 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
|
From before the test meal to after the test meal in weeks 1, 2, 3, 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paige M Cunningham, PhD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
June 17, 2026
First Submitted That Met QC Criteria
June 17, 2026
First Posted (Actual)
June 23, 2026
Study Record Updates
Last Update Posted (Actual)
June 23, 2026
Last Update Submitted That Met QC Criteria
June 17, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0150706
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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