Breakfast Study for Premenopausal Women
Who is conducting this study?
This study is led by NancyKeim, PhD, and colleagues at the USDA, ARS, Western Human Nutrition Research Center (WHNRC). The funding for this study comes from USDA, CSREES This study has been reviewed and approved by the UCD Committee for the Protection of Human Subjects.
What is the purpose of the study?
You are being asked to participate in a research study. We seek healthy women to participate in a cross-sectional study examining the metabolic, hormonal and behavioral factors associated with breakfast skipping.
Who can participate?
120 healthy pre-menopausal women, ages 20-45 who regularly eat breakfast or who regularly skip breakfast will be enrolled in the study.
Who is NOT eligible to participate?
•• Individuals with inconsistent breakfast eating habits
•• Individuals who use tobacco products
•• Individuals taking prescription or over-the-counter medications that include corticosteroids, beta-adrenergic blockers, medications for weight loss, immune-suppressants, amphetamines, and anti-depressant, anti-anxiety, and anti-psychotic medications
•• Women who are pregnant, nursing, or planning to become pregnant
What do I need to do to participate?
Women will complete a telephone questionnaire to determine eligibility. If eligible, volunteers will complete a health-screening visit at 430 West Health Sciences Drive on the UC Davis campus, including questionnaires, height, weight, hip and waist circumference and vital signs. In addition, we will also ask you to complete a questionnaire about your menstrual cycle and to report the dates of the beginning and end of your last two periods.
If selected for the study, you will be asked to participate in a three hour baseline visit . In this visit, you will complete questionnaires about your typical eating habits, physical activity, sleep patterns, mood and anxiety levels. Additionally, a simple computer task will be administered to you that simulates real-life decision making. Finally we will measure your body's muscle and fat composition using a body composition tracking system known as the BodPod.
Home Assessment: Immediately after the baseline visit you will begin to collect information for us at home. You will wear an activity monitor continuously for one week and provide three days of saliva samples. (During the baseline visit, you will be shown how to collect data for us during the home assessment period.)The activity monitor is a lightweight device that is worn around the waist and measures your body movements. Saliva samples will be taken up to fifteen times during a three day period. The samples will be used to monitor various metabolic hormones. Because the laboratory visits are scheduled during a particular phase of your menstrual cycle, we will need you to keep an accurate record during the home assessment period. In addition, we will conduct three unannounced dietary recalls over the phone.
Laboratory Visits:There will be two laboratory visits, scheduled about three days apart, that will last 5 hours each. You will be asked to arrive at approximately 11:30 am or noon.
All volunteers will complete:
1) Saliva Samples. You will also be asked to collect 10 saliva samples at specific times during each of the five hour lab visits. These samples will be used to monitor a metabolic hormone.
2) Blood Draws. A catheter will be inserted into your arm shortly after you arrive at the WHNRC for each of the 5 hour visits for the collection of 5 blood samples taken at specific times. We will use the samples to measure your blood glucose, insulin, lipids and several other metabolic hormones.
3) Challenging Tasks. During one of the visits you will participate in two challenging tasks for a total of about 15 minutes, so we can examine your body's physical response to these tasks. These tasks will involve speech and subtraction problems. Your performance will be videotaped and used only by the research staff.
4) Control Period. During one of the visits you will be asked to watch a relaxing nature video for about 25 minutes.
5) Written Questionnaire. At each of the visits you will be asked to fill out questionnaires about your mood, activity and sleep patterns.
In addition, you will be asked to consume a standard lunch on each of these days which will consist of a turkey and cheese sandwich "wrap", potato chips, baby carrots, and canned peaches. You will be provided bottled water to drink. This lunch will provide approximately 30 % of your daily caloric needs and you will be required to eat the entire meal.
Evaluation panel
Approximately 2-6 weeks after the end of the testing week, you will come back the WHNRC to participate in a 2 hour group meeting led by one of our investigators and designed to identify the reasons why people choose to either skip or eat breakfast.
Compensation
You will receive $10 for completing and returning all dietary recalls and food records, saliva samples and physical activity monitors; $25 for completing each of the three lab test days and $15 for attending the evaluation panel, for a total of $100.
What should I do if I have more questions?
Call 530-752-5177 and press 4 to leave a message. Someone from the study will get back to you.
