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Food, Adolescence, Mood, and Exercise (FAME)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High sugar versus low sugar meals
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern California Health Science Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Sugar/Low Fiber (HSLF) meals

Low Sugar/High Fiber (LSHF) meals

Arm Description

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

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

Outcomes

Primary Outcome Measures

changes in physical activity as measured by accelerometer over an 8 hour in lab visit
Physical activity is measured by an actigraph accelerometer which is worn over the right hip on a belt.

Secondary Outcome Measures

Changes in blood glucose levels over 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.
Changes in insulin over 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.
Stress (objective and perceived) fluctuations over 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

Full Information

First Posted
December 9, 2013
Last Updated
March 29, 2017
Sponsor
University of Southern California
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02015377
Brief Title
Food, Adolescence, Mood, and Exercise
Acronym
FAME
Official Title
Food, Adolescence, Mood and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Sugar/Low Fiber (HSLF) meals
Arm Type
Experimental
Arm Description
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
Arm Title
Low Sugar/High Fiber (LSHF) meals
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
High sugar versus low sugar meals
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in physical activity as measured by accelerometer over an 8 hour in lab visit
Description
Physical activity is measured by an actigraph accelerometer which is worn over the right hip on a belt.
Time Frame
physical activity is measured continuously by accelerometer worn on belt
Secondary Outcome Measure Information:
Title
Changes in blood glucose levels over 5 hours
Description
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.
Time Frame
Every 30 minutes for 5 hours
Title
Changes in insulin over 5 hours
Description
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.
Time Frame
Blood was drawn every 30 minutes for 5 hours
Title
Stress (objective and perceived) fluctuations over 5 hours
Description
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
Time Frame
Every 30 minutes for 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Spruijt-Metz, Ph.D
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael I Goran, Ph.D
Organizational Affiliation
University of Southern California
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California Health Science Campus
City
Los Angeles
State/Province
California
ZIP/Postal Code
90032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Food, Adolescence, Mood, and Exercise

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