Food, Adolescence, Mood, and Exercise

NCT02015377 | Completed DMC

• 2 other identifiers: FAME-HS-07007355P60MD002254-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in blood glucose levels over 5 hours

  Every 30 minutes for 5 hours

• Changes in insulin over 5 hours

  Blood was drawn every 30 minutes for 5 hours

• Stress (objective and perceived) fluctuations over 5 hours

  Every 30 minutes for 5 hours

Study Arms (2)

High Sugar/Low Fiber (HSLF) meals

EXPERIMENTAL

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

Other: High sugar versus low sugar meals

Low Sugar/High Fiber (LSHF) meals

EXPERIMENTAL

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

Other: High sugar versus low sugar meals

Interventions

High sugar versus low sugar meals OTHER

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

High Sugar/Low Fiber (HSLF) meals; Low Sugar/High Fiber (LSHF) meals

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children (9th - 11th grade, \~14-17yrs)
• Male and female
• Hispanic or African American

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Southern California Health Science Campus

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donna Spruijt-Metz, Ph.D

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Michael I Goran, Ph.D

  University of Southern California

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 19, 2013
• Study Start: September 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)