ClinicalTrials.gg
CompletedNCT03321305FHSUpdated Oct 25, 2017

Eating Frequency and Visceral Adipose Tissue, Body Fat, and Obesity Risk in Hispanic College Freshmen

An observational study in Obesity, Metabolic Disease and Eating Behavior, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by University of Texas at Austin · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 24 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Obesity
  • Metabolic Disease
  • Eating Behavior
  • Adiposity
  • Sleep
  • Physical Activity
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In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 100 is below the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

For the survey portion of this study will be general in that participants must be currently enrolled freshmen students at UT Austin. Students can be male or female and of any ethnicity. Participants must be 18 years of age or older.

The In-Person Visit inclusion/exclusion criteria will be more extensive and include the following:

Ethnicity: This portion of the study will be limited to self-reported Hispanics because of their high risk of visceral adiposity and metabolic disorders.

Eating Frequency We will enroll half Infrequent Eaters (≤2 EOs per day) and half Normal Eaters (≥3 EOs per day). Eating frequency groups will be identified via the previous survey data and verified with 24-hour diet recalls.

BMI Status: We will include a natural selection of normal, overweight and obese students based on the Centers for Disease Control growth charts.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to MRI scanning, as visceral adipose tissue is a primary outcome
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 2013-2017

  2. 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

    Time frame: 2013-2017

  3. 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).

    Time frame: 2013-2017

Secondary outcomes

  1. 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

    Time frame: 2013-2017

  2. 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).

    Time frame: 2013-2017

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Study locations

1 site
  • University of Texas at Austin
    Austin, Texas 78712, United States
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References and documents

Individual participant data

Plan to share: No — No individual data will be shared. Only aggregate data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03321305
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Nov 13, 2013
Primary completion
Jun 1, 2016
Completion
Nov 1, 2016
Last update
Oct 25, 2017

Study contacts

Jaimie N Davis, PhD,RD
principal investigator · University of Texas at Austin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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