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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03321305
Other study ID # 2013-11-0017
Secondary ID
Status Completed
Phase N/A
First received October 16, 2017
Last updated October 20, 2017
Start date November 13, 2013
Est. completion date November 1, 2016

Study information

Verified date October 2017
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Due to the increased focus on education and changing lifestyle, college students are particularly susceptible to poor overall health and wellness due to inadequate sleep and poor dietary choices. This is particularly important because the behavioral choices college students make may affect their risk of chronic disease. This study will research these topics via an online survey, in person visit and stool sample.


Description:

It is important for college students to establish healthy habits during college because they are likely to stay with them throughout their lives. The transition to college has been identified as a critical period contributing to the rise in obesity rates. Several studies have shown that the initial transition to college is associated with rapid weight gain and the average weight gain in the first year of college ranges from 3.5 to 8.8 pounds. While decreased dietary fiber, fruits and vegetables and junk food consumption are among the dietary factors that have been linked to increased obesity rates in college students, little is known about the effect of eating patterns on health in this population. Furthermore, lack of sleep, smoking, binge drinking, and infrequent eating are all associated with negative health outcomes. Previous work with college age youth has found that several behaviors cluster together. The goal of the Online Survey portion is to expand on current findings, as well as examine the interrelationships of alcohol use, sleep, smoking, and eating patterns with adiposity and metabolic disease risk in a population of freshmen college students.

Eating frequency research has consistently found a negative association between the number of eating occasions (EOs) per day and adiposity, as well as metabolic disease risk in both youth and adult populations. Our group has shown that infrequent eating is linked to increased obesity measures, blunted insulin action, and deleterious lipid parameters in multiple populations of overweight Hispanic youth (8-18y). However, to date, no group has looked at the effect of eating frequency on adiposity and metabolic disease risk in a sample of overweight Hispanic college freshmen. In 2012, for the first time in history Hispanic high school graduates (69%) were more likely to be enrolled in college than Non-Hispanic Whites (NHW; 67%) and Blacks (63%) and last year Hispanic students represented 24% of freshman enrollment at the University of Texas at Austin (UT), Hispanics also showed the largest increase among all minority groups. Thus, the goal of the In-Person Visit is to examine the relationship between eating frequency and adiposity/metabolic disease risk in this extremely high-risk population of Hispanic freshmen and potentially identify interventions that may reduce this risk within such a crucial period of life.

The human body contains 100 trillion microbes, and microbial genes outnumber human genes 100:110. Over the past decade, interest in the complex ecosystem of gut microbiota has increased immensely and research has uncovered a relationship between gut microbiota, metabolic disease, and obesity. Both diet and obesity have been shown to alter the gut microbiota12,13. However, few studies have investigated how individual dietary components can affect the gut microbiota in humans. The Stool Sample portion of the study is an exploratory investigation of the relationship between dietary components and gut microbiota composition in college-aged Hispanic freshmen.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 1, 2016
Est. primary completion date June 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria:

- Male or female;

- Ages 18-24 years;

- Self-reported Hispanics (all four grandparents must be Hispanic)

- 50% of the sample will be self reported infrequent eaters (those who eat less than 2 eating occasions per day), as measured by 24-hr recalls

- 50% of the sample will be self-reported frequent eaters (those who report 3 or more eating occasions per day)

- A natural selection of normal, overweight and obese subjects will be recruited.

Exclusion Criteria:

- Subjects with serious medical disease as identified from a health history form;

- Pregnant;

- Taking any medications known to influence body composition or glucose/insulin action or psychoactive medications;

- Are diagnosed with diseases that may influence glucose/insulin indices or body composition;

- Have participated in a weight loss, dietary, or physical activity intervention in the past 6 months;

- Have a learning impairment that would complicate survey administration;

- Have braces, a pacemaker, or any other contraindications to MRI scanning, as visceral adipose tissue is a primary outcome

Study Design


Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary College Students Habits and Obesity Risk Examine the interrelationships of alcohol use, sleep, smoking, eating patterns, and physical activity with obesity (i.e., BMI parameters as measured by height in meters and weight in kilograms) in a population of freshmen college students 2013-2017
Primary College student habits and type 2 diabetes risk factors Examine the interrelationships of alcohol use, sleep, smoking, eating patterns, and physical activity with type 2 diabetes risk factors (i.e., glucose, insulin, insulin resistance as measured by fasting blood glucose) in a population of freshmen college students 2013-2017
Primary College student habits and adiposity Examine the interrelationship of alcohol use, sleep, smoking,eating patterns, and physical activity on adiposity (i.e., total body fat as measured by BodPod and visceral fat and liver fat as measured by MRI). 2013-2017
Secondary Stool Samples and Gut Microbiome Exploratory investigation of the relationship between dietary components and gut microbiota composition (specifically microbial diversity) in college-aged Hispanic freshmen 2013-2017
Secondary College Habits and Circulating lipids Examine the interrelationship of alcohol use, sleep, smoking, eating patterns and physical activity levels on lipids (i.e., total cholesterol, triglycerides, and very low-density lipoprotein as measured by fasting blood draw). 2013-2017
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