Dietary Guidelines for Americans Study

Who is conducting the study?

Kevin Laugero, PhD from the Western Human Nutrition Research Center (WHNRC) and Department of Nutrition, at the University of California, Davis.

What is the purpose of this study?

The purpose of this research is to see if achieving and maintaining a healthy body weight is the main health promoting recommendation of the Dietary Guidelines for Americans (DGA) for women at risk for diabetes, heart disease or stroke.

Where is the study being conducted?

WHNRC, 430 West Health Sciences Drive, University of California, Davis, California, 95616

Who can participate in this study?

Adult women between the ages of 35 - 64 who are overweight or obese, and have either high cholesterol levels, high blood sugar levels or high blood pressure. Must be willing to consume study foods, participate in moderate physical activity, and have blood, urine and stool samples collected. Must be willing to visit WHNRC 28 times over the course of seven months.

What would exclude me from participating in the study?

• You are pregnant, breastfeeding or planning to become pregnant within the duration of the study.
• You are vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages.
• You have been diagnosed with medical diseases or conditions other than pre-hypertension, pre-diabetes, or dyslipidemia.
• You do graveyard/overnight work shifts or are forced to stay awake all night.

What can I expect to happen during the study?

First, you will be screened for eligibility with a 15-minute telephone interview. If you meet the inclusion criteria, you will be consented and scheduled for an in-person screening.

During the in-person screening we will confirm that you meet the inclusion criteria by taking a height and weight, blood pressure, body composition analysis, and a fasting blood draw. Once your eligibility is confirmed, you will then be consented for the full study and be scheduled for your baseline test days.

Your baseline test days will include collecting body measurements, collecting blood, urine, and stool, evaluating usual activity monitoring, measuring resting metabolic rate, continuous glucose monitoring, liver health assessment, lifestyle and behavior questionnaires, , and enrollment in a physical activity program.

Next, you will start the controlled feeding portion of the study and this will last eight weeks. You will be randomized to a specific diet group and will be required to eat and drink only the food and beverages provided to you by the staff. The food will be refrigerated or frozen and intended to be heated up and eaten on specific days. The meals will contain essential nutrients and will be tailored to your specific calorie needs. Due to nature of the study, you could be assigned to a Dietary Guidelines style diet (for either weight stability or weight loss) or a typical American diet for weight loss. Your assignment will be random. After eight weeks of feeding, you will have post-feeding test days. These are the same tests conducted in the baseline, pre-feeding test days.

After the post-feeding test days, you will enter the “follow-up period” for 17 weeks. During this time, you will no longer be provided meals by the center and may continue to eat and drink as you please. Over these 17 weeks you will be provided with some educational material on healthy eating and physical activity. Moreover, you will be asked to remotely complete a few questionnaires and come to the center monthly for a weigh-in.

At the end of the “follow-up period”, you will be asked to come to the center for the last test day. This test day will include several measurements such as weight, height, waist and hip circumference, blood pressure, resting heart rate, body composition, fasting blood draw and collect of a fecal sample.

What is your compensation from this study?

If you fully complete the study, the total compensation is $900. If you complete only a portion of the study, you will be compensated only for those portions completed.

What should I do if I have questions or want to participate in the study?

Please contact our study line at 530-752-5177, press #7, and leave a message that you are interested in the Dietary Guidelines study. One of our study team members will contact you to let you know more about the study and answer questions.