nUTRITION, the Brain, and Women’s Health STUDY
Who is conducting this study?
This study is led by Kevin Laugero, PhD, and colleagues at the USDA, ARS, Western Human Nutrition Research Center (WHNRC). The funding for this study comes from USDA, ARS, WHNRC. 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 will be examining the influence of metabolic measures such as cortisol and insulin, measured in saliva, and social factors, measured by questionnaires, on eating behaviors. We will measure the brain’s response to photographs of everyday objects. This research will help identify factors which may be modified to improve eating behaviors and potentially body weight health.
Who can participate?
Twenty women, ages 42 - 52, who are generally healthy and self-identify as peri-menopausal will be enrolled in the study.
Who is NOT eligible to participate?
· Individuals who cannot refrain from smoking during the 5 hour study visit
· Individuals who cannot refrain from drinking alcohol for 2 days prior to the study visits
· Individuals taking prescription or over-the-counter medications that include corticosteroids, oral contraceptives, beta-adrenergic blockers, medications for weight loss, immunosuppressants, amphetamines, and anti-depressant, anti-anxiety, and anti-psychotic medications
· Women who are pregnant, nursing, or planning a pregnancy
· Individuals with neuromuscular disorders such as multiple sclerosis, amyotrophic lateral sclerosis, or Parkinson’s disease, and individuals with insulin dependant diabetes
· Women who have had menopause confirmed
· Women who have had a weight change greater than 10 lbs in the preceding 6 months
· Women who are unable to consume foods in a standard lunch meal, including cheese and nuts, or have severe food allergies or intolerances to foods.
· Individuals with travel plans that do not permit full participation
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 you cannot remember we will ask you to record this information over the following two months.
If selected for the study, you will be asked to complete the following visits:
Laboratory Visits: There will be two laboratory visits, scheduled about one month apart, that will last 5 hours each. You will be asked to arrive at approximately 11:30 am or noon.
All volunteers will be asked to complete:
1) Saliva Samples. You will also be asked to collect 9 saliva samples at specific times during each of the five hour lab visits. These samples will be used to monitor a metabolic hormone.
2) DEXA Scan - You will be asked to complete questionnaires about your eating behaviors and mood. In addition, we will measure your body’s bone, muscle and fat measured using a Dual Energy X-ray Absorptiometry (DEXA) using a whole body scan. The DEXA machine will then scan your body with low-energy x-rays. Prior to the scan you will be asked to take a pregnancy test. If you are pregnant or think that you might be pregnant, you should not participate in this study.
3) Challenging Tasks. During one of the visits you will be asked to participate in two challenging tasks for a total of about 15 minutes, so we can examine your body’s responses to these tasks. These tasks will involve speech and subtraction problems. Your performance will be videotaped and used only by the research staff.
4) Meditation Period. During one of the visits you will be asked to watch a nature video for about 20 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 cheese quesadilla, mild salsa, potato chips, and canned peaches. You will be provided bottled water to drink. You will be required to eat the entire meal.
MRI Scan Visit: There will be one MRI Scan visit, scheduled at the UCDMC Imaging Research Center between 2 pm and 5 pm. You will be asked to fill out questionnaires, and lie in a magnetic resonance imaging machine (MRI) for about 1 hour. We ask that you refrain from eating for about 2 hours before the scan.
2) You will receive $10 for completing a screening visit, $50 for the first laboratory visit, $50 for the second lab visit, and $50 for the MRI visit which is a total of $160.
What should I do if I have more questions?
Please call 530-754-7781 and Press #1