- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04836416
Appetite Variability
Appetite Ratings and Eating Patterns
Study Overview
Detailed Description
Screening - The study will be advertised through various public media sources (social media, posted flyers, Purdue Today) and a verbal conversation. Participants responding to the advertisements will be scheduled for a screening visit. This meeting will begin with a full description of the study, and investigators will secure informed written consent. Participants will complete questionnaires eliciting demographic (age, biological sex, BMI, fat%), dietary (eating traits), and health (acute and chronic disease history) information. Height and weight will be measured. For those choosing to enroll, investigators will obtain baseline measurements to confirm eligibility. Individuals qualified and volunteering to participate in the trial will complete multiple questionnaires about eating habits ( Meal pattern questionnaire, Power of food scale, 0 Study Materials - Appetite Training Material.pdf 0 Study Materials - ASA24 instruction .pdf 0 Eating Trait questionnaires.pdf 0 Study Materials - Appetite Lexicon Quiz.docx 0 Hourly Appetite and Thirst Ratings.pdf 0 Study Timeline.pdf Emotional eating scale, Eating inventory, Food craving inventory, Adult eating behavior scales, Self-regulation of eating behavior questionnaire, Barrot Impulsiveness scale). Participants will also learn how to record their energy intake through the ASA-24 system. Then, participants will get training on the lexicon of appetite sensations with a video tutorial, followed by an online quiz to confirm their understanding of the concepts. At least 90% of correct responses are required to pass the appetite lexicon training. Failure to satisfactorily convey an understanding of the concepts will result in an offer to repeat the training two more times or be rejected from the study. Study Procedure - Enrolled participants will have a virtual meeting with a researcher (E. Cheon) once a week through Zoom to remind participants about the necessity and method for recording of appetite/thirst ratings, dietary recalls, and physical activity to be completed during three days (2 non-consecutive weekdays and
1 weekend day). Participants will be asked to report to the laboratory for instruction on recording appetitive sensations (hunger, fullness, thirst), food intake, physical activity at baseline (week1), week 9, and 17 on 3 days (2 non-consecutive weekdays and 1 weekend day). Ratings of hunger, fullness, and thirst will be recorded on their cell phones/computers via a web-based Qualtrics survey every waking hour for 3 days. All entries are time and date stamped to ensure the ratings are made at the intended times. Participants will be provided hourly alarms to ensure regular recording.
Concurrently, participants will keep a diet record with an ASA-24 system and free-living energy expenditure will be measured using a physical activity tracking application on the same days of appetite ratings.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-65 years.
- Body weight fluctuation of <2.5 kg in the past 3 months.
Exclusion Criteria:
- Having an acute disease.
- Planning to initiate or terminate medication known to affect appetite.
- Planning to initiate or terminate lifestyle behaviors that could affect energy balance
- Age <18 or >65 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young Adult/Normal
Age 18-35, BMI 18.5-24.9
|
Observational
|
Young Adult/Overweight and Obese
Age18-35, BMI greater than 25.0
|
Observational
|
Adult/Normal
Age 36-50, BMI 18.5-24.9
|
Observational
|
Adult/Overweight and Obese
Age 36-50, BMI greater than 25.0
|
Observational
|
Older Adult/Nornal
Age 51-65, BMI 18.5-24.9
|
Observational
|
Older Adult/Overweight and Obese
Age 51-65, BMI greater than 25.0
|
Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hunger
Time Frame: 4 months
|
A positive association between hunger and eating frequency.
|
4 months
|
Thirst
Time Frame: 4 Months
|
A positive association between thirst and energy intake from beverages.
|
4 Months
|
Fullness
Time Frame: 4 Months
|
A positive association between fullness and portion size.
|
4 Months
|
Energy Intake
Time Frame: 4 Months
|
A positive association between combined hunger (determinant of eating frequency) and fullness (determinant of portion size) ratings and energy intake.
|
4 Months
|
Age
Time Frame: 4 Months
|
A negative association between appetitive sensation intensities and age.
|
4 Months
|
Gender
Time Frame: 4 Months
|
No significant association between appetitive sensation intensities and gender.
|
4 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard D Mattes, PhD, Purdue University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-1651
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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