- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731522
Eating Frequency Study
June 17, 2023 updated by: Hollie Raynor, The University of Tennessee, Knoxville
The purpose of this study is to examine the influence of two Eating Frequency prescriptions, meal (energy intake occurring during three meals per day) and grazing (energy intake occurring every two to three hours per day), on consumption during an ad libitum meal consumed at the end of the day, overall daily energy intake, and ratio of energy intake to energy expenditure.
It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
20 men and women of healthy weight will participate in this study.
The complete study design will be a 2 x 2 mixed factorial design, with the between-subject factor of order and a within-subject factor of eating condition (meal or grazing).
Depending upon the eating condition, participants will be provided with a morning meal and an afternoon meal (meal) or two small meals and three snacks to be consumed every 2-3 hours (grazing).
The types of foods and amount of foods provided to participants will be identical in each condition; the only difference in the conditions is the time spacing during the day when the foods are consumed.
The primary dependent variable will be amount, both grams and energy, of food consumed during an ad libitum meal consumed in the evening at the completion of the meal condition, overall daily energy intake, and ratio of daily energy intake to energy expenditure.
It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.
Study Type
Interventional
Enrollment (Estimated)
20
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 Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37996-1920
- The University of Tennessee-Knoxville
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age between 18 and 35 years
- body mass index (BMI) between 18.5 and 24.9 kg/m2
- no history of overweight or obesity
- unrestrained eater (<12 on Three Factor Eating Questionnaire [TFEQ])
- regularly participate in at least 150 minutes of moderate-intense physical activity per week over the previous 4 weeks
Exclusion Criteria:
- currently taking medication that affects appetite or food intake
- have a medical condition affecting eating or currently following a therapeutic diet
- are currently participating in a weight loss program and/or taking weight loss medication
- have gained or lost > 5% of body weight during the past 6 months
- diagnosed with type 1 or 2 diabetes
- have had bariatric surgery
- report disliking foods used in the investigation (scoring a 1 or 2 on a 5-point Likert scale)
- report having allergies to foods used in the investigation
- currently smoke
- report binge eating
- are graduate students in the Department of Nutrition
- are pregnant, lactating, < 6 months post-partum.
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EF condition
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total grams of ad libitum meal consumed
Time Frame: 1 year
|
The foods that will be used in this investigation are Tyson Chicken Breast Tenders, Ore-Ida Tater Tots, Birds Eye Steamfresh Pure & Simple green beans, and Sarah Lee Butter Pound Cake.
Participants will be provided with ad libitum amounts of the foods, and the foods will be measured in grams to the tenth decimal point on an electronic food scale (Denver Instrument Co., Arvada, CO) before and after the meal.
The weight of the container will also be measured.
Total grams of each food consumed during the session will be determined by subtracting pre- and post-consumption weight of food.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
December 1, 2012
Primary Completion (Actual)
December 31, 2018
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 14, 2012
First Submitted That Met QC Criteria
November 14, 2012
First Posted (Estimated)
November 21, 2012
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 17, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- MTRI-Basic EF Study
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.
Clinical Trials on Eating Frequency
-
Sonova AGCompleted
-
University of FloridaCompletedFruit and Vegetable Selection in the Lunchroom | Consumption Frequency Versus Selection FrequencyUnited States
-
University of Castilla-La ManchaHospital Nacional de Parapléjicos de ToledoCompleted
-
Cairo UniversityUnknown
-
Prince of Songkla UniversityEnrolling by invitationHigh-Frequency VentilationThailand
-
Erasme University HospitalRecruitingBronchoscopy | High-Frequency Jet VentilationBelgium
-
University of Illinois at Urbana-ChampaignCompletedFruit and Vegetable Consumption | Cooking FrequencyUnited States
-
OridionCompletedIntubated Neonates That Require High Frequency VentilationIsrael
-
University of Illinois at Urbana-ChampaignNational Cattlemen's Beef AssociationRecruitingDietary Habits | Muscle Protein Synthesis | Meal FrequencyUnited States
Clinical Trials on EF condition
-
Everfront Biotech Co., Ltd.Not yet recruitingPancreatic Cancer
-
University of California, San DiegoRady Children's Hospital, San DiegoRecruitingOverweight and Obesity | Attention-Deficit Hyperactivity DisorderUnited States
-
University Hospital, MontpellierRecruitingIschemic Stroke | Migraine | Migraine With AuraFrance
-
Concordia University, MontrealCanadian Institutes of Health Research (CIHR)RecruitingAging | Age Related Hearing LossCanada
-
University Hospital, ToursUnknownPremature Baby 25 to 32 WeeksFrance
-
Wake Forest University Health SciencesMedtronicRecruitingHiatal Hernia | Esophagogastric Junction DistensibilityUnited States
-
IRCCS Fondazione Stella MarisUniversity of Pisa; University of Florence; Anastasis Società Cooperativa SocialeNot yet recruitingExecutive Functions in Cerebral PalsyItaly
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Ewing's SarcomaUnited States