- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02015377
Food, Adolescence, Mood, and Exercise (FAME)
March 29, 2017 updated by: Donna Spruijt-Metz, University of Southern California
Food, Adolescence, Mood and Exercise
The overall objective of FAME is to examine the metabolic and behavioral links between dietary intake and its subsequent effects on circulating appetite regulating hormones and physical activity levels in Hispanic and African American adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our major unifying hypothesis is that diets comprised of high sugar, energy dense, low fiber meals, are associated with a post-prandial metabolic, hormonal and psychosocial profile that promotes overeating and sedentary behavior.
Specific Aims: (1) Compare the effects of a HIGH SUGAR, LOW FIBER (HSLF) meal versus a LOW SUGAR, HIGH FIBER (LSHF) meal on insulin dynamics, selected gut peptides, mood and levels of physical activity in minority adolescents, (2) Explore the effects of HSLF versus LSHF meals on post-prandial ad libitum food intake, (3) Explore differences in reaction to HSLF versus LSHF meals in lean and overweight adolescents and (4) Examine ethnic differences in meal responses between Hispanic and African American children.
Research Design and Methods: We will employ a cross-over design with a 3-4 week washout period where normal weight and overweight African American and Hispanic youth come to our Observation Lab in a fasting state and consume high sugar and low sugar meals at separate visits in random order.
Meal consumption will be followed by five hours of intensive observation in which we quantify real-time physical activity in laboratory setting that was designed to offer equally attractive choices for active or sedentary behaviors.
After 5 hours, participants will be offered food platters with an array of food types and be invited to eat ad libitum.
Subsequent energy and nutrient intake will be quantified.
Rationale: This study is prompted by three observations: (1) The disproportionate levels of obesity and risk for type 2 diabetes and cardiovascular disease in Hispanic and African American children; (2) The rapid decline in physical activity during puberty especially in Hispanic and African American adolescents, and (3) Children, and particularly minority children, tend to have diets high in added sugars and low in fiber.
Thus, it is imperative to improve our understanding of the interrelationships between dietary intake, physical activity and risk factors for type 2 diabetes and cardiovascular disease in minority youth, particularly during puberty, when physical activity levels significantly decline.
Relevance to public health: This study will provide new information on the acute effects of meal composition on mood and subsequent choices of physical activity in normal weight, healthy overweight and insulin resistant overweight Hispanic and African American youth.
Furthermore, we suggest that our findings may potentially lead to a better understanding the acute affects of poor nutritional choices on physical activity in minority adolescent populations at high risk for obesity, diabetes type 2, and other obesity-related diseases.
Study Type
Interventional
Enrollment (Actual)
100
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
-
-
California
-
Los Angeles, California, United States, 90032
- University of Southern California Health Science Campus
-
-
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
14 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children (9th - 11th grade, ~14-17yrs)
- Male and female
- Hispanic or African American
Exclusion Criteria:
- Diabetes
- Currently in weight loss or exercise program
- BMI < 85th percentile as defined by CDC growth curves
- Use of medications that influence body weight or SI
- Syndromes that influence body composition
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Sugar/Low Fiber (HSLF) meals
Comparing the impact of High sugar/Low fiber (HSLF) meal versus Low Sugar/High Fiber meals (LSHF) on insulin and glucose profiles, gut hormones (ghrelin, amylin, leptin) free fatty acids, cortisol, mood (MOOD), meaning of physical activity (MEANPA), and physical activity engagement (PA) in overweight African American and Hispanic youth
|
Participants visit our lab for two 8-hour periods with a minimum of two weeks washout in between.
In one visit they receive high sugar low fiber meals, in the other they receive low sugar, high fiber meals.
The order of meals is randomized
|
Experimental: Low Sugar/High Fiber (LSHF) meals
Comparing the impact of High sugar/Low fiber (HSLF) meal versus Low Sugar/High Fiber meals (LSHF) on insulin and glucose profiles, gut hormones (ghrelin, amylin, leptin) free fatty acids, cortisol, mood (MOOD), meaning of physical activity (MEANPA), and physical activity engagement (PA) in overweight African American and Hispanic youth
|
Participants visit our lab for two 8-hour periods with a minimum of two weeks washout in between.
In one visit they receive high sugar low fiber meals, in the other they receive low sugar, high fiber meals.
The order of meals is randomized
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in physical activity as measured by accelerometer over an 8 hour in lab visit
Time Frame: physical activity is measured continuously by accelerometer worn on belt
|
Physical activity is measured by an actigraph accelerometer which is worn over the right hip on a belt.
|
physical activity is measured continuously by accelerometer worn on belt
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in blood glucose levels over 5 hours
Time Frame: Every 30 minutes for 5 hours
|
On the day of the meal visits, participants arrived at the Observation Lab on campus at approximately 7:00 am after a 10-hour overnight fast.
Topical anesthetic (EMLA) will immediately be placed on likely forearm IV sites.
After every effort has been made to "break the ice" and develop rapport, a saline lock intravenous catheter was inserted and secured for stability in a forearm vein, not involving wrist or elbow joint in order to maximize motility during free activity.
After a baseline blood draw (at -5 min), participants will be provided with a breakfast test meal.
Blood is drawn every 30 minutes for 5 hours.
The saline lock and blood draws were conducted by a trained and certified nurse.
|
Every 30 minutes for 5 hours
|
Changes in insulin over 5 hours
Time Frame: Blood was drawn every 30 minutes for 5 hours
|
On the day of the meal visits, participants arrived at the Observation Lab on campus at approximately 7:00 am after a 10-hour overnight fast.
Topical anesthetic (EMLA) will immediately be placed on likely forearm IV sites.
After every effort has been made to "break the ice" and develop rapport, a saline lock intravenous catheter was inserted and secured for stability in a forearm vein, not involving wrist or elbow joint in order to maximize motility during free activity.
After a baseline blood draw (at -5 min), participants will be provided with a breakfast test meal.
Blood is drawn every 30 minutes for 5 hours.
The saline lock and blood draws were conducted by a trained and certified nurse.
|
Blood was drawn every 30 minutes for 5 hours
|
Stress (objective and perceived) fluctuations over 5 hours
Time Frame: Every 30 minutes for 5 hours
|
Every 30 minutes at the time of the blood draws, salivary cortisol was measured by salivette and perceived stress was measured by validated Visual Analogue Scale
|
Every 30 minutes for 5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Donna Spruijt-Metz, Ph.D, University of Southern California
- Study Director: Michael I Goran, Ph.D, University of Southern California
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
September 1, 2007
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (Estimate)
December 19, 2013
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAME-HS-0700735
- 5P60MD002254-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | 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
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on High sugar versus low sugar meals
-
Purdue UniversityGrain Food FoundationRecruitingHigh Whole Grain and Low Sugar | Medium Whole Grain and Low Sugar | Low Whole Grain and Low Sugar | Low Whole Grain and High SugarUnited States
-
University of California, San FranciscoTouro University, CaliforniaActive, not recruitingOverweight and ObesityUnited States
-
Uppsala UniversityCompleted
-
University of DelawareCompletedHealthy Aging | Healthy DietUnited States
-
University of DelawareNational Institute of General Medical Sciences (NIGMS)Active, not recruitingAging | Healthy DietUnited States
-
Virginia Polytechnic Institute and State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedValidation StudiesUnited States
-
Max Planck Institute for Metabolism ResearchYale UniversityCompletedBehavior, Eating
-
Bruce A. GriffinImperial College London; University of CambridgeCompletedNon-alcoholic Fatty Liver Disease (NAFLD)United Kingdom
-
VU University of AmsterdamDutch Heart Foundation; ZonMw: The Netherlands Organisation for Health Research... and other collaboratorsCompleted
-
Clinical Nutrition Research Centre, SingaporeCompleted