- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079635
Breakfast and Energy Expenditure in Young Women
August 16, 2017 updated by: Jamie Baum, University of Arkansas, Fayetteville
The Effect of Breakfast Intake on Energy Expenditure and Hunger in Young Women
The purpose of this research is to determine if body composition influence the effect of breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure response in normal weight, overweight, and obese young women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
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
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72704
- University of Arkansas
-
-
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 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- BMI over 18.5
- No medication
Exclusion Criteria:
- Food allergies
- Habitual breakfast skipping (> 5 times per week)
- Picky eater
- Dietary restrictions
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Normal Weight
This group will be administered two breakfast beverages with a one- to two-week washout period between beverages.
The beverages will be a control or an isocaloric, macronutrient matched breakfast beverage with omega-3 fatty acids.
|
Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
|
|
Active Comparator: Overweight and Obese
This group will be administered two breakfast beverages with a one- to two-week washout period between beverages.
The beverages will be a control or an isocaloric, macronutrient matched breakfast beverage with omega-3 fatty acids.
|
Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy metabolism/expenditure
Time Frame: Four hours
|
Energy expenditure and thermic effect of feeding will be measured using a TrueMax 2400 metabolic cart
|
Four hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite
Time Frame: Four hours
|
Postprandial appetite will be assessed using visual analog scales
|
Four hours
|
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)
February 15, 2017
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
March 9, 2017
First Submitted That Met QC Criteria
March 9, 2017
First Posted (Actual)
March 14, 2017
Study Record Updates
Last Update Posted (Actual)
August 21, 2017
Last Update Submitted That Met QC Criteria
August 16, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 16-09-124
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.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Control
-
Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)Enrolling by invitationCritical Illness | Respiratory Failure | Mechanical VentilationUnited States
-
Claudia M. WittCompleted
-
University of California, San FranciscoWithdrawn
-
The George InstituteChanghai Hospital; University of CalgaryRecruitingIschemic Stroke, AcuteCanada, Australia
-
Takeshi MorimotoUniversity of the RyukyusCompletedCoronary Artery Disease | Hypertension | Type 2 Diabetes | DyslipidemiaJapan
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
Johnson & Johnson Vision Care, Inc.TerminatedRefractive Error CorrectionUnited States
-
Universidad Nacional de Educación a DistanciaMinisterio de Economía y Competitividad, SpainUnknownChronic Pain | FibromyalgiaSpain
-
University of California, Los AngelesThe National Council on Aging; City of Los Angeles Department of Aging; Los Angeles...Completed
-
Vanderbilt University Medical CenterCompleted