Individual Metabolism and Physiology Signature (iMAPS) Study

 

Who is conducting the study?

 

Nancy L. Keim, PhD, and Sean H. Adams PhD, from the WesternHumanNutritionResearchCenter (WHNRC) and Department of Nutrition, at the University of California, Davis.

 

Where is the study being conducted?

 

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

 

What is the purpose of this study?

 

We hope to learn more about how the food you eat affects measures of metabolic processes going on in the body. Overall these processes are reflected in the 'metabolome' - a term applied to the measurement of a multitude of biological compounds in blood, urine, feces, saliva, and breath. By conducting a complete characterization of the metabolome, we hope to discover new metabolites that change in response to diet and might serve as indicators of health.

 

Who can participate in this study?

 

Overweight adult women between the ages of 20 and 65 years old who are insulin resistant or have elevated blood lipid profiles.

 

What would exclude me from participating in the study?

••         BMI <25 and >39.9 kg/m²

••         Metabolic diseases

••         Gastrointestinal disorders

••         Pregnant or breastfeeding

••         Current use of tobacco products

••         Strenuous physical activity >30 min/day

••         Weight change >5% of body weight during the previous 6 mo

• Dietary restrictions that would interfere with consuming the intervention foods.

What can I expect to happen during the study?

 

Volunteers will be asked to come to the WHNRC approximately 25 times over the course of about 12 weeks to complete the study.  For 8 of those weeks, volunteers will receive all of the foods they will need to maintain their weight.  Below is a brief description of what happens during the study.

 

Volunteers will be screened for eligibility first with a 30-minute telephone interview and then with 2 separate 4-hour visits to the WHNRC.  Each visit will require an overnight fast of 12 hours. The visits will be separated by one week and will include the following activities one or both times. 

• Review study schedule and menu items
• Review and sign consent
• Height and weight measurements
• Waist circumference measurements
• Blood pressure and pulse measurements
• Metabolic testing
• Blood collection
• Oral glucose tolerance test (OGTT)

 

Results received from the 2 screening lab visits will determine eligibility into the main study.  Only qualified volunteers will be asked to participate in the remaining study visits. 

 

Week 1:

 

Orientation Visit (1 day):

Volunteers will come to the WHNRC for a 3-h visit and will review and sign the consent form, review study schedule, take vitals and body size measurements, complete questionnaires, and will receive training for at home date collections including the 24-hour dietary recalls and saliva collections.

 

Pre-study testing (2 days):  The following is a list of activities that will be performed during this period. 

••         Cardiovascular function

••         Body Composition:

• Blood collection
• Metabolic testing
• Heart rate variability
• Oral glucose tolerance test (OGTT)
• Oral liquid meal challenge
• Challenging Mental Task:
• Cognitive testing
• Saliva, urine, stool, skin secretion and breathe collection

 

Diet Group Assignment (Weeks 2-9) and home collection:

 

Following week 1, volunteers will follow a structured diet plan for the next 8 weeks and will come to the WHNRC or the Sacramento location at least twice a week to pick up all foods and beverages. Volunteers will be randomly assigned to receive one of two diets.  Both diets will be designed to meet each volunteer's specific caloric needs for maintaining body weight, include the same amounts of protein, carbohydrates, and fat, and will meet all essential nutrient recommendations. The diets will be composed of natural foods available in the supermarkets. The diets will differ with respect to the types of foods used to supply the carbohydrates, protein and fats.    

 

At various times during this 8 week period, volunteers will wear activity monitors, complete diet related questionnaires and collect urine and stool samples

 

                                                        Week 3: 

 

Early study testing (2 separate days): Activities performed during the pre-study testing will be repeated 

 

                                                        Week 9:

 

End of study testing (2 separate test days):Activities performed during the pre-study testing will be repeated 

 

What is your compensation from this study?

 

If the study is completed the total compensation is $1000.  Volunteers will be compensated only for the portions of the study you complete.

 

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

 

For questions, contact the study coordinator, Lucas Welch at 530-754-5248

To qualify for the study, please call 530-752-5177 #2.