Nutrition 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 seek healthy normal and overweight women to participate in a cross-sectional study examining the determinants of nutritional behavior and its relationship to body weight health.
Who can participate?
Forty 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 meat, cheese, and nuts, or 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 a one hour Baseline Visit. In this visit, 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.
Home Assessments: At the end of the baseline visit, we will schedule your home assessments which will consist of wearing an activity monitor continuously for two weeks and taking three saliva samples. The activity monitor is a lightweight, watch like device that is worn around the waist and measures your body movements. The saliva samples will be taken three times during a three day period. The samples will be used to monitor metabolic hormone. In addition, during the week prior to your first laboratory visit, we will conduct three unannounced dietary recalls over the phone.
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) Blood Draws. The catheter flushed with saline 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 four metabolic hormones.
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) Control 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 turkey and cheese sandwich, potato chips, baby carrots, and canned peaches. You will be provided bottled water to drink. This lunch will be scaled to provide approximately 30 % of your daily caloric needs and you will be required to eat the entire meal.
Compensation
2) You will receive $10 for completing a screening visit, $85 for the baseline assessments ($10) and the first laboratory ($75) visit and $75 for the 2nd laboratory visit which is a total of $170.
What should I do if I have more questions?
Call 530-752-5177 and press 8 to leave a message. Someone from the study will get back to you.
