Food, Adolescence, Mood, and Exercise

Obesity Clinical Trial

— FAME  

Official title:

Food, Adolescence, Mood and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015377
• Other study ID #: FAME-HS-0700735
• Secondary ID: 5P60MD002254-04
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: March 29, 2017
• Start date: September 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• High sugar versus low sugar meals
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

Locations

Country	Name	City	State
United States	University of Southern California Health Science Campus	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	physical activity is measured continuously by accelerometer worn on belt
Secondary	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.	Every 30 minutes for 5 hours
Secondary	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.	Blood was drawn every 30 minutes for 5 hours
Secondary	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	Every 30 minutes for 5 hours