Food, Adolescence, Mood, and Exercise

NCT ID: NCT02015377

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

High sugar versus low sugar meals

Intervention Type 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

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

Group Type EXPERIMENTAL

High sugar versus low sugar meals

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Donna Spruijt-Metz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donna Spruijt-Metz, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Michael I Goran, Ph.D

Role: STUDY_DIRECTOR

University of Southern California

Locations

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University of Southern California Health Science Campus

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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5P60MD002254-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FAME-HS-0700735

Identifier Type: -

Identifier Source: org_study_id

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