You may be eligible to participate in a research study investigating metabolic adaptations to weight loss with and without exercise.

Who can participate?

• Men & women 18-40 years of age
• Classified as overweight / obese (Body Mass Index 30-40 kg/m2)
• Weight Stable (+/- 6 pounds for past 2 months)
• Non-smoker who is relatively healthy without history of cardiovascular or metabolic disease
• Do not currently participate in regular exercise
• Individuals not taking any medications affecting metabolism or inflammation
• Women must not be pregnant, lactating, or menopausal

You will undergo/receive:

• Body composition analyses and exercise fitness assessments
• Clinical visits with blood and tissue sampling and metabolic testing
• Nutritional counseling from a Registered Dietitian
• Financial compensation upon completion the study
• An Activity Monitor to track your physical activity
• Participants randomized into the Exercise groups will exercise 4 days per week

STUDY DETAILS:

Preliminary Testing. If you meet the eligibility criteria after completing the general screening questionnaire, you will be asked to take part in some tests to determine if you are eligible to participate. 

Remote Screening Appointment.  If eligible to screen after completing the general pre-screening questionnaire, you will be contacted to set up a remote screening appointment (via phone or video) where a study team member will discuss the study in detail and will answer any questions you have relating to the study. This meeting will take about 30 minutes to 1 hour to complete.  

After the study team member receives your eSignature on the informed consent document, you will be asked to complete the following:

• Detailed Medical History Questionnaire

• American College of Sports Medicine (ACSM) / American Heart Association (AHA) Health/Fitness Facility Pre-participation Questionnaire

• Godin Physical Activity Assessment

 

Physical Screening Appointment. This in-person visit will occur at the Kinesiology Building’s Clinical Research Suite (CRS) located on the University of Michigan’s Central Campus and will take about 1 hour to complete.  At this appointment, you will complete the following: 

• Height, weight, waist circumference, blood pressure, heart rate, and temperature measurements

• Resting electrocardiogram (EKG or ECG) Test

If you are deemed eligible based on the results of the preliminary testing, you will be eligible to enroll in the study.

Clinical Phenotyping Measurements. After your eligibility is confirmed, you will undergo the following in-person testing procedures to determine body composition (via DEXA, BIA), regional fat distribution (via MRI), aerobic fitness (VO2max), resting metabolic rate (RMR), and glucose tolerance (OGTT).  These tests will be completed before weight loss, after the 10% weight loss is achieved, and at the 6-Month Follow-up.

• The DEXA, BIA, and VO2max tests will be completed in a single visit that will take about 1 hour to complete.  
• The RMR and OGTT will be conducted on a separate occasion from the DEXA, BIA, and MRI.  This will appointment will be scheduled in the morning after an overnight fast and will take about 3 hours to complete. 
• The MRI measurement will be conducted at the Michigan Medicine MRI and Research Facility and will take about 1 hour to complete.  

* During the COVID-19 pandemic era prior to the VO2max test, you will be required to take a COVID-19 test 48-96 hours before this appointment.  If a subject tests positive for COVID-19, any related in-person appointments will be cancelled and/or postponed.  

Experimental Trial Appointments. You will complete a comprehensive metabolic testing appointment:

• before weight loss
• after a 10% weight loss is achieved

These experimental trial appointments will include comprehensive metabolic testing that will assess the rates of glucose production in your liver and your insulin sensitivity. At these appointments we will take several blood samples and a small piece of fat from your stomach. 

Both experimental trial appointments will be identical and will take place in the Michigan Clinical Research Unit (MCRU) located in Michigan Medicine’s Cardiovascular Center (CVC).

Exercise Treatment: You will be randomized into one of two different treatment groups:

• Moderate Intensity Continuous Training (MICT) exercise group
• No exercise (Control) group

If you are selected to be in the exercise group, will be performing aerobic-type exercise (i.e., cycling, running, elliptical – you choose!) 4 days per week.  You will begin a 2-3-week exercise familiarization protocol where all 4 exercise sessions are supervised by an exercise trainer.  Supervised exercise sessions will be done remotely by phone or at the “Exercise Training Center” in the School of Kinesiology at the University of Michigan.

10% Weight Loss: After completing the first Experimental Trial appointment, you will work with a Registered Dietitian Nutritionist (RDN) to reduce your daily caloric intake to attain a weight loss of 1-2 pounds per week until a 10% weight loss is achieved.  During the first 2-4 weeks of the weight loss intervention, you will be asked to use study provided meal replacement shakes (for example, Optifast® shakes) to help facilitate your weight loss.

Mid-Point Trial: After achieving a 5% weight loss, you will be scheduled to come to the School of Kinesiology Clinical Research Suite (CRS).  At this appointment, those randomized to the exercise group will perform their regularly prescribed exercise – those randomized into the No exercise (Control) group will rest quietly – and the study team will collect a small fat tissue sample from the abdominal area before exercise, and again 2h and 24h afterwards.

Follow-Up Period: At 2-, 4-, and 6-months after you have completed the post-weight loss experimental trial, we will measure your body composition (via DEXA, BIA) and collect blood samples for analysis of relevant clinical health biomarkers.  At the 6-month appointment, the study team will also assess your regional fat distribution (via MRI), aerobic fitness (VO2max), glucose tolerance (Oral Glucose Tolerance Test – OGTT) and take a small sample of fat from the abdominal area.  

Optional Muscle Tissue Biopsy Sub-Study: If you choose to participate in the Optional Muscle Tissue Biopsy Sub-Study, we will perform a muscle tissue biopsy procedure to collect a small amount of muscle tissue from your thigh during your Pre-Weight Loss Experimental Trial (before weight loss), Post-Weight Loss Experimental Trial (after a 10% weight loss is achieved), and 6-Month Follow-up appointments to assess metabolic changes in your muscle tissue.

You can take part in the “WAX” research study even if you decide to opt out of the Optional Muscle Tissue Biopsy Sub-Study.

PARTICIPATION INCENTIVES
As a thank you for taking part in the study, a pro-rated financial compensation will be provided. No compensation will be given for completion of the Screening Procedures, the Clinical Phenotyping Procedures, or 2- and 4-Month Follow-up Procedures.

Subjects will receive $150 upon completion of the Pre-Weight Loss Experimental Trial Appointment, $150 upon completion of the Mid-Point Experimental Trial, $250 upon completion of the Post-Weight Loss Experimental Trial Appointment, and $200 upon completion of the 6-Month Follow-up Procedures (total of $750 upon completion of the entire study).

Those who choose to participate in the Optional Muscle Tissue Biopsy Sub-Study will receive an additional $50 for each muscle tissue biopsy procedure that is performed (total of $150 for completing all 3 muscle biopsy procedures).

Those who complete the entire study will get to keep their Fitness Activity Tracker that was used for data collection during the study.

To sign up to screen for this study, select “Weight Loss (WAX) Research Study” on our general online screening questionnaire (myumi.ch/51VM2).