Not yet recruiting NCT07663214
The Combined Effects of Energy Density and Variety on Intake
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Variety, High Variety, Low ED, High ED.
- Who it may be relevant to
- Registry conditions: Eating Behaviors. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Low Variety
Only one food served - Other High Variety
Three foods served - Other Low ED
Foods are low in energy density - Other High ED
Foods are high in energy density
Primary outcome measures
- Change in food intake [Time frame: Weeks 1, 2, 3, 4]
- Change in energy intake [Time frame: Weeks 1, 2, 3, 4]
Secondary outcome measures (12)
- Change in water intake [Time frame: Weeks 1, 2, 3, 4]
- Change in meal duration [Time frame: Weeks 1, 2, 3, 4]
- Change in eating rate [Time frame: Weeks 1, 2, 3, 4]
- Change in sip count [Time frame: Weeks 1, 2, 3, 4]
- Change in bite count [Time frame: Weeks 1, 2, 3, 4]
- Change in bite size [Time frame: Weeks 1, 2, 3, 4]
- Change in switching between bites and sips [Time frame: 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]
- 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]
- Change in rating of thirst [Time frame: From before the test meal to after the test meal in 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]
- Change in rating of nausea [Time frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Cornell University — Ithaca
Identifiers
NCT: NCT07663214 · IRB0150706