- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03321305
Eating Frequency and Visceral Adipose Tissue, Body Fat, and Obesity Risk in Hispanic College Freshmen (FHS)
Freshman Health Study
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Texas
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Austin, Texas, Stany Zjednoczone, 78712
- University of Texas at Austin
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Tylko przypadek
- Perspektywy czasowe: Przekrojowe
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
College Students Habits and Obesity Risk
Ramy czasowe: 2013-2017
|
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
|
College student habits and type 2 diabetes risk factors
Ramy czasowe: 2013-2017
|
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
|
College student habits and adiposity
Ramy czasowe: 2013-2017
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Stool Samples and Gut Microbiome
Ramy czasowe: 2013-2017
|
Exploratory investigation of the relationship between dietary components and gut microbiota composition (specifically microbial diversity) in college-aged Hispanic freshmen
|
2013-2017
|
College Habits and Circulating lipids
Ramy czasowe: 2013-2017
|
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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Jaimie N Davis, PhD,RD, University of Texas at Austin
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2013-11-0017
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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