You are being asked to participate in a biomedical research project to investigate how type 2 diabetes (T2D), specifically in overweight and obese populations, changes how the protein we consume is used by our body, and to determine if exercise training has a beneficial role optimizing dietary protein efficiency (how well your body uses the protein you eat to build and repair body components, such as muscles, skin, enzymes, and hormones).
Participating in this study will involve undergoing health tests (body composition, resting metabolic rate, oral glucose tolerance test, muscle performance, strength assessment, and cardio fitness assessment), following a Mediterranean diet (a diet plan consisting of white meat, fruits, and vegetables), and participating in 12 weeks of progressive exercise training. Participation will also include collecting blood, breath, urine, and feces during 2, 6+ hours lab visits at the beginning of the trial, and 2, 6+ hours lab visits at the end of the trial. There will also be periodic (every 3 weeks) 3-day diet recalls and psychological well-being tests. Total participation will last about 14 weeks. Potential risks related to this research include mild pain, bruising, infection, and dizzines s. Benefits associated with this research include the 12 weeks of supervised structured exercise training and diet counseling from a registered dietitian. You will also be compensated for your time (please see Compensation section). Additionally, there are no costs for participating in this study. Before agreeing to participate in this research study, it is essential to read the consent form. Please ask the researcher to explain any words or information you do not understand.
Principal Investigator Name and Title:
Nicholas A. Burd, Ph.D., Professor
Department and Institution:
Health and Kinesiology
Contact Information:
156 Louise Freer Hall,
906 S Goodwin Ave,
Urbana, IL 61801
Email: naburd@illinois.edu
Office: (217) 244-0970
Sponsor:
American Diabetes Association
IRB Number:
IRB25-0851
You have been asked to join this study because you may be a good fit. We need people who are age 65 or older and are not active. In order to join, you need to have been weight stable for the past six months and have a BMI > 25, < 40. Around 30 participants will be involved in this study.
Your participation in this research is voluntary. Your decision whether to participate or not, will not affect your current or future dealings with the University of Illinois at Urbana-Champaign. If you decide to participate, you can withdraw at any time without repercussions.
Figure 1. Overview of study procedures for the habituation and intervention weeks.1. Enrollment
Informed Consent and Screening Questionnaires: Prior to any testing, procedures and risks associated with participation will be explained to you; you will have the opportunity to ask any questions about the research/participation. If you are interested, you will be asked to read and sign an informed consent document. Upon signing, you will be asked to fill out a medical history questionnaire and a physical activity questionnaire . Weight and height will be measured to confirm your BMI is within the range of study eligibility. H emoglobin A1C (HbA1c) levels will be measured from a small blood collection during the enrollment session to determine eligibility. Briefly, we will use a single-use lancet to collect a drop of blood from a finger (similar to a blood poke for a glucometer). Additionally, we will assess your risk for neuropathy using two validated questionnaires outlined in the following section. Should you fail to meet the inclusion criteria (or exhibit any exclusive qualities) during this session, research personnel will immediately terminate the session and provide an explanation to you. Neuropathy Testing: The Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy. It consists of 15 yes-or-no questions regarding foot sensation, including pain, numbness, and temperature. Additionally, we will use the LEAP foot screen questionnaire to assess risk levels based on factors such as loss of protective sensation, deformity, and ulcer history. Briefly, we will have you lie down on your back with your feet exposed. We will then use a filament similar to a fishing line and touch different areas of both feet, asking if you can feel the sensation. Those with a risk factor above 3 will be determined ineligible.
2. Preliminary Testing Day 1(~4 hours; conduct pre- and post-study)
Preparation: We ask that you do not perform heavy exercise for 72 hours prior to your appointment. You will arrive for a morning appointment after an overnight fast . This means no food or beverages at least 10 hours before your appointment . In the morning, you cannot have breakfast, coffee, tea, etc. It is ok to drink water. Anthropometrics: We will measure your height and weight to make sure you qualify for joining the study. Since you already did the surveys, an eligible body mass index (BMI) will mean you can join. Body mass index is a measure of body weight divided by your height squared. If you have a BMI under 25 kg/m2 you will not qualify for the study. If your BMI is more than that, you will continue with testing. After measuring your height and weight, we will measure your blood pressure. Then, you will have your body scanned. This scanner measures the percentage of your body that is made up of fat and muscle. For the scan you will be asked to take off all metal objects (piercings and jewelry, for example). You will then be asked to lie down. A team member will position you for the scan. The scan lasts 6-10 minutes and you will be asked to lie still the whole time.Resting Metabolic Rate (RMR): RMR is assessed using a device that measures oxygen consumption and carbon dioxide production. Prior to the beginning of the test, you will lie flat on your back on a table and a clear, hard plastic hood and soft, clear plastic drape will be placed over your neck, head, and shoulders to capture expired gases. You will then lie motionless without falling asleep while oxygen and carbon dioxide concentrations are captured. Testing will conclude when RMR is stable for at least 20 min (typically ~30 min from the onset).3-day Diet Record: Current diet intake will be assessed through an online automated self-administered (ASA24) diet record system. You will receive their individual and private username and password. You will be asked to record 3 consecutive days (2 weekdays, 1 weekend day). As it is an online system, you can complete off-site at your leisure. You will also be asked to complete 3-day diet records throughout the 12-week intervention (see figure 1). Oral Glucose Tolerance Test (OGTT): Blood samples will be collected over 2 hours. An intravenous catheter (instrument used to collect blood) will be placed in your hand or arm vein for repeat blood sampling. Blood samples will be collected at 7 time points (0, 15, 30, 45, 60, 90, and 120 minutes). After the initial blood draw (time 0 min), you will drink a sugar beverage containing 75g of sugar. Hemoglobin A1C (HbA1c) levels will be measured from a blood sample collected during the first testing session to determine eligibility. During this test, you may work on a computer, read, use your phone, or watch television. You will be asked to repeat this test after the study is completed. WHOOP wearables : We will distribute a WHOOP wearable at the time of the OGTT test. This is an activity tracking device (like the accelerometer you will be given leading into the IAAO trial). This activity tracker is waterproof, and you will be asked to wear is 24/7 during the time of enrollment. The device connects via Bluetooth to your mobile device. We will ask you to download the WHOOP app using your study identifier. If you are unable or unwilling to download the APP on your personal device, we can use a lab device- you will just not be able to see your personal metrics.
3. Preliminary Testing Day 2 (~3 hours, conduct pre-study)
Preparations: We ask that you do not perform heavy exercise for 72 hours prior to your appointment. You will arrive for a morning appointment after an overnight fast . This means no food or beverages at least 10 hours before your appointment . In the morning, you cannot have breakfast, coffee, tea, etc. It is ok to drink water. Upon arrival to the lab, we will have you sit in a chair for 5 minutes to get a resting heart rate and resting blood pressure. Cardiorespiratory fitness assessment: Peak aerobic capacity, the highest amount of oxygen your body can use when you're working really hard, and maximum heart rate (HR) will be estimated using a below maximum effort stationary bicycle exercise test, a standard method for assessing fitness in adults with type 2 diabetes. Briefly, you will pedal on the bike for 3 minutes at a resistance of 0kp, keeping a cadence of 50 rotations per minute (RPM) as a warm-up. Then, we will have you pedal for 3-4 minutes or until we reach a steady state at 0.5kp, at 50RPM. Resistance is increased every 3-4 minutes until heart rate reaches 85% of age-predicted maximum heart rate, calculated as 220-age. Muscle Performance : We will assess your maximum strength by measuring how much weight you can lift 10 times in a row (10-RM).. Following a 5-minute warm-up on a stationary bike at a self-selected resistance and speed, you will be tested on one upper-body and one lower-body exercises using standard weight machines. Exercises include leg press and chest press. Following your warm-up, you will perform a set of 8-10 reps at approximately half the weight of what you think you can lift ten times. You will then rest for 1-2 minutes. Subsequently, your next set will be around 90% of your subjective 10 repetition maximum weight. We will gradually increase the weight after each set by 2.5-5.0% at a time until you can no longer lift it. A 2-minute rest will be given between maximum attempts and five minutes between exercises. We will repeat the muscle performance test at week 6 and week 13 of the intervention.Hand grip strength: We will measure your hand grip strength. You will be asked to sit upright in a chair, with your knees and hips at 90° and with your back supported. Your arm on the dominant side will be positioned against your body with your elbow positioned at a 90° angle and your wrist in a neutral position. Then you will be instructed to squeeze the dynamometer as hard as possible. Following this, we will do the same thing with your other hand.Isokinetic Testing: The HUMAC NORM Isokinetic Dynamometer (CSMi, Stoughton, Massachusetts) will be used to assess peak torque, average workload, and average power in concentric tests (measurement of force produced during shortening (i.e a bicep curl). You will be positioned upright in a seated position with bent knees. The lower part of your dominant leg will be secured to a padded, rigid metal bar using a Velcro strap. Maximal power of the knee extensor muscles will be obtained at 60 deg/s. Strong verbal encouragement will be provided to kick as hard and as fast as possible throughout the full range of motion for 3 sets of 5 repetitions. A minimum of 60 seconds of rest after each set of 5 contractions to minimize muscle fatigue during the power assessment. Figure 2. Protocol of Dietary Protein Efficiency Trial4. Dietary Protein Efficiency Trial (7 hours per trial; conduct pre- and post-study)
Habituation (3 days prior to the trial)
Accelerometers: Prior to leaving the laboratory, you will be given an accelerometer (Actigraph) to assess levels of daily physical activity (i.e step count). Research personnel will demonstrate the proper use of the device and instruct you on how to wear it before your Dietary Protein Efficiency trial. Following the demonstration, you will be reminded to refrain from any strenuous exercise and wear the device for two days leading into the trial. Meal Pickup: You will come on-site to pick up meals for the next two days leading up to your dietary protein efficiency trial. You will be asked to store meals and prepare them according to the manufacturer's instructions. Meals will be provided fresh, negating risk of food spoilage. Preparations: We ask that you do not perform heavy exercise for 72 hours prior to your appointment. You will arrive for a morning appointment after an overnight fast . This means no food or beverages at least 10 hours before your appointment. In the morning, you cannot have breakfast, coffee, tea, etc. It is ok to drink water. Also, in the morning, please refrain from consuming anti-blood clotting medication like ibuprofen, aspirin, etc.
On the day of the trial
IAAO Drink: After collecting baseline measurements, you will be asked to drink a specially prepared series of protein beverages. This series of drinks (6 total) contains a small amount of a natural substance called phenylalanine, an amino acid that your body typically gets from proteins in food. In addition to the natural phenylalanine, there is a small percentage of labeled phenylalanine (13 C phenylalanine)- this is called a stable isotope.
13 C] phenylalanine). This "tag" does not change how the amino acid behaves in your body- it simply allows us to track where the protein goes and how your body uses it. Breath Collection: At 8 time points (-30, -15, 0, 240, 270, 300, 330, and 360 minutes), we will measure the air you exhale. To do this, you only have to breathe normally through a hose . Immediately after, you will exhale into a separate mouthpiece attached to a plastic bag . This procedure does not have a pain risk, nor will it affect your physical well-being. These samples help us know how much protein is used for energy, instead of building muscle. The equipment is sterilized between each participant. VCO2: At two separate time points (-30 and 240 minutes) we will measure your carbon dioxide production (VCO 2 ). This will be determined from exhaled air sampled by an open-circuit mouthpiece attached to a hose. Immediately after VCO 2 analysis is performed (5 min), you will be asked to exhale into a separate mouthpiece attached to a plastic bag. This breath sample is stored in a sterile vacutainer for downstream analysis of the [ 13 C]phenylalanine tracer concentration in the exhaled air. The measurement of VCO 2 and the measurement of tracer concentration in the exhaled air allow us to assess how much of the protein is used for energy, instead of protein synthesis. You are not expected to experience any discomfort from this procedure, nor will it influence your physical well-being. Urine Collection: Researchers will provide you with urine cups for a urine sample. You will be directed to the location of the restrooms and asked to provide a small sample (~30mL) of urine at time points -30, 0, 240, 300, and 360 minutes.
Figure 3. Overview of the Gut microbiota trial5. Gut microbiota trial (6.5 hours per trial; conduct pre- and post-study)
Preparations: We ask that you do not perform heavy exercise for 72 hours prior to your appointment. You will arrive for a morning appointment after an overnight fast . This means no food or beverages at least 10 hours before your appointment. In the morning, you cannot have breakfast, coffee, tea, etc. It is ok to drink water. Also, in the morning, please refrain from consuming anti-blood clotting medication like ibuprofen, aspirin, etc. Blood Collection: An intravenous catheter will be placed in your hand or arm vein for repeat blood sampling. Blood samples will be collected 10 times (-30, 0, 30, 60, 90, 120, 150, 180, 240, and 300 minutes) during each gut microbiome trial (pre- and post-training). ~16 mL of blood will be collected at each time point (7 mL plasma, 7 mL serum, and ~2 mL waste). Thus, the total volume collected during each microbiome trial is ~160 mL. Blood will be collected into evacuated tubes using Luer-Lok access device connected to a 4-way stopcock. Between draws, the catheter will be kept patent using a saline drip at a low rate (~60 cc/hr). There will be a total of 10 blood collections (Figure 3
).Mediterranean-based modeled meal: At time point 0, you will be asked to ingest ~20g protein drink enriched with L-[ring- 13 C6 ] Phenylalanine to allow us to follow the protein as it is digested and used in your body. The amino acid and fat composition Fecal Sample Collection: You will be asked to collect the first stool sample produced after the gut microbiota trials. You will be provided all necessary materials needed to complete the stool collection process and will be asked to deliver the sample the next time you come to the lab for a study visit. You will be asked to record the time and date of sample collection. 6. Exercise Training (~1 hour per session):
Endurance training: For aerobic-based training, supervised exercise sessions will occur on a stationary bike (treadmills and ellipticals are also options, although not preferred). Your exercise intensity will be controlled by heart rate (HR) and Rate of Perceived Exertion (RPE) using Borg's original scale (6-20 points; 6 meaning no effort at all, 20 means hardest you can possibly work). Exercise intensity will be progressive according to Table 1. Upon arrival to the lab, we will have you sit in a chair for 5 minutes to get a resting heart rate and resting blood pressure. Glucose monitoring will take place throughout all exercise sessions.
Strength Training : On strength training days, you will warm up on a stationary bike for 5 minutes before each training session. The trained session will consist of 1-3 sets of lower-body exercises (leg press, leg extension, and leg curl) on guided machines, or upper-body exercises on guided machines (seated chest press, seated shoulder press, seated row) on alternating training days. All sessions will be separated by 2-3 days. Training intensity will be progressive but also based on your comfort level. During the first week of training (week 0), the training intensity will be gradually increased from ~60% 1RM (10-15 repetitions) to ~70% 1RM (10-12 repetitions). Training sessions will be supervised, and you will have instructions on proper lifting technique throughout the intervention. Upon arrival to the lab, we will have you sit in a chair for 5 minutes to get a resting heart rate and resting blood pressure. Glucose monitoring will take place throughout all exercise sessions. Glucose monitoring will take place throughout all exercise sessions. Additionally, Within an hour post exercise, on the last exercise testing session, we will take a blood sample using a single poke needle.
7. Psychological Evaluation
Exercise training visits are time-intensive, and, as such, to maximize the information obtained, we will assess psychological well-being during the intervention. The International Personality Item Pool (IPIP-50) is a 50-item assessment of the Five Factor Model (Openness to Experience, Conscientiousness, Extraversion, Agreeableness, and Neuroticism/Emotional Stability). Additionally, the PRETIE-Q is a 16-item questionnaire designed to determine your personal exercise intensity preferences and your perceived tolerance of exercise intensity. The Dispositional Resilience Scale (DRS-15) will be used to assess your level of resiliency, and the Hospital Anxiety and Depression Scale (HADS), a 14-item scale used to determine the severity of anxiety and depressive symptoms you have been feeling within the last 7 days.
This research will be performed at Freer Hall on the University of Illinois Campus (906 S Goodwin Ave, Urbana, IL 61801). You will need to come to the study site two times prior to the beginning of the study period for preliminary testing. Once the study period begins you will be asked to come to Freer Hall 2-3 times weekly over the course of a 12-week period. The estimated duration of each visit is listed in Table 1. Table 1. On-site duration estimates for the entire study.
Fasting risks Most physiological baseline measurements require being fasted (i.e., 10-12 h without food). Fasting is a common state every morning before breakfast. Fainting occurrences are rare, but we have safety procedures in place to offset any symptoms.
Dizziness : There is slight risk of feeling dizzy/lightheaded. Participants will be lying down during these procedures (RMR, DXA scan, OGTT, experimental trial days) to reduce this feeling. This is usually caused by a sudden drop in blood pressure if standing up too quickly. Blood pressure will be frequently monitored, and participants will be asked to slowly stand up whenever leaving the bed.
Fainting : There is also a risk of fainting when fasted. You will be accompanied by a research team member at all times and will be escorted to the bathroom as needed. If fainting occurs, you will be safely lowered to laying down position and feet elevated (promoted blood flow back to brain). Glucose and water will also be readily provided (helps increase blood pressure). Fainting during a fast is usually caused by low blood sugar due to prolonged time without food. Furthermore, before leaving these tests, you will be provided with a snack.
Blood Collection Risks Blood sampling is a common medical practice and involves few risks if proper precautions are taken. Our main strategy to minimize risk with blood sampling is good training and education. Dr. Burd is highly trained in of blood sampling and he has trained his students extensively. In addition, we have sent members of the research team to train at Christie Clinic with their head/lead phlebotomist. Their ability to properly locate vessels and perform blood collection was confirmed. Moreover, Drs. Scott Paluska and Jared Willard have confirmed their competency for venipuncture. Bruising: There is a chance of internal bleeding if adequate pressure is not maintained upon removal of the needle. This may cause some minor discomfort and could result in bruising/skin discoloration. Bruising could last up to a few weeks. To minimize this, pressure will be held on the site for 5-10 min with sterile gauze after removing the needle.Infection: There is a risk of infection. We minimize this by inserting needles under sterile conditions. Before inserting, the site will be cleaned with an alcohol swab. A new, sterile butterfly needle will always be used for the insertion into the arm. Blood clot: Rarely, trauma to the vessel wall could result in a small blood clot. This clot could become lodged in a smaller vessel. However, we have never experienced this after several thousand blood draws.Fainting: Some people may get shaky, dizzy, or light headed during blood draws. On rare occasions, these symptoms can be the result of low blood sugar. If we see this, we will give you 15 g of glucose and elevate your feet to treat the low blood sugar. To reduce the risk of falling, you will lay flat on a bed during and after the blood draw. Members of the research team are trained in First Aid and CPR. We will provide aid if we need to.
DXA Scan Risks Radiation exposure: DXA scans are commonly performed and considered safe. During the scan, you are exposed to a very low amount of radiation. The amount of radiation is less than one tenth of the amount used during a normal chest X-ray and equivalent to one day of exposure to natural background radiation. The amount of radiation used during a DXA scan is considered safe for adults but there may be risks to unborn babies. Please tell the investigators if there is a possibility you may be pregnant.Do you have any reason to believe that you are pregnant?
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If you have no reason to believe your are pregnant, please sign here. By participating in this study, you accept the potential risks to an unborn baby, even if you do not believe you could be pregnant.
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Researcher-provided meals risks
Food-borne illness: Food storage will occur under GMP (Good Manufacturing Practices) conditions in a designated food preparation room of the Exercise and Cardiovascular Research Laboratory. Further, meals will be purchased only from companies who follow the same guidelines. Meals will be stored prior to pick up at ~2 degrees celsius. In absence of a food allergy, eating these meals poses no risk to the you. Resistance Exercise and Strength Testing
Soreness: There is a chance that you will feel some soreness after exercise. This soreness may be noticeable the day after exercise but may not be noticeable until a few days afterwards. Further, soreness could get progressively worse as time goes on. Soreness after exertion is normal and is unlikely to seriously affect your daily activities. There isn't much that can be done to ameliorate this risk. However, it is likely that soreness will be minimal given that you are not sedentary and have experience with this type of exercise previous to study participation.Musculoskeletal Injury: When you exercise, there is a chance of injury to bone or muscle. These injuries are usually minor but can be serious or worsen if improperly cared for. If you do get injured, exercise will be ended immediately. Since you are usually active, there is a good chance that you already participate in the type of exercise that will be employed in this study. Thus, the risk of injury is generally low. Risk of this type of injury cannot fully be eliminated. However, close monitoring, getting used to the equipment, and proper training in technique help to minimize the chance of severe injury.Sudden Death: There is a theoretical risk that heart irregularities or sudden death may occur during exercise. These events typically occur in people who already have heart conditions. As such, if you have any type of heart condition, you are not eligible to participate in this study. As with the risk of injury, close monitoring during and after the exercise will help to minimize this risk. If, despite precautions, an emergency does occur during exercise, research personnel are trained in first aid and CPR. The lab has advanced life-saving equipment (e.g., AED) on hand to respond in any manner necessary; including calling 911 if deemed appropriate.Compartment Syndrome: Compartment syndrome resulting from exercise is a rare complication. There are limited publications on this after acute exercise, all of which are single case studies. Chronic exertional compartment syndrome is somewhat more common, but still quite rare. Dr. Burd has consulted with other colleagues in the field with an estimated combined experience of >40,000 obtained thigh biopsies in a variety of patient settings and exercise scenarios using a 5 mm Bergstrom muscle biopsy needle and they have 0 documented cases of compartment syndrome. Similarly, in his own work (>2,000 thigh biopsies collected), he has never seen a case. Nevertheless, there is one case study describing an instance of thigh compartment syndrome of the vastus lateralis following a needle biopsy from an 89-year-old cancer patient. Additionally, the biopsy technique used was not the Bergstrom technique that we use for our research. With these case studies in mind, there is very little we can do to minimize the risk. With regards to acute exercise, you are familiarized with the exercises and equipment used in the study which limits the novelty of the stimulus. Further, we follow up with you in the days after your participation to ensure no complications arise from our procedures.
Biohazardous waste risks
Waste generated from above procedures will be dealt with according to UIUC Division of Research Safety (DRS) mandatory guidelines. All sharps will be placed in approved containers specifically designed for this purpose (obtained from DRS). Biopsy needle components are disassembled and soaked in enzymatic cleaner. Subsequently, the needle components are rinsed with water and rendered sterile via steam sterilization at 121°C for 60 min. All other waste will be placed in specifically purchased bags and subsequently sterilized (121°C for 60 min) prior to disposal. Sterilization is confirmed using special autoclave indicator tape on each item being sterilized. Further, autoclave validations using spore vials are performed monthly. Autoclave tape and spore vials are obtained from DRS.
If you have any questions or problems with severe soreness, bleeding, or if the biopsy site becomes red or warm to the touch, please contact any of the researchers (contact information can be found at bottom of the informed consent form). If you were to sustain injury, as a result of participation in this research project, that requires further medical treatment you are strongly advised to do so. However, this does not mean that the treatment you receive is free of charge, and we have not set aside money to pay for related injuries. The University of Illinois does not provide medical or hospitalization insurance coverage for participants in this research study nor will the University of Illinois provide compensation for any injury sustained as a result of participation in this research study, except as required by law. Signing this form does not waive any legal rights.
The direct benefits of participating in this research are that you will receive one-on-one diet counseling with a registered dietitian and 12 weeks of supervised exercise. Further, this research will benefit society as results will increase our understanding of the nutritional insights and treatment plans for older adults with Type 2 Diabetes.
You have the option to not participate in this study. Unfortunately, there are currently no alternative forms of participation for this study. Any affiliations with university and/or department will not be altered by participating or declining participation.
We will use all reasonable efforts to keep your personal information confidential, but we cannot guarantee absolute confidentiality. When this study is discussed or published, no one will know that you were in the study. But, when required by law or university policy, identifying information (including your signed consent form) may be seen or copied by:
a) WHOOP- data will be stored securely in WHOOP's Snowflake data warehouse, with strict access controls. Only the designated data steward (Dr. Gregory Grosicki) and approved internal analysts will have access, and only to the de-identified data required for analysis
b) The Institutional Review Board that approves research studies
c) The Office for Protection of Research Subjects and other university departments that oversee human subjects research
d) University and state auditors responsible for oversight of research
You will receive $1000 upon full completion of study procedures. If participation is withdrawn before completion, prorated rates will be applied based on the level of completion.
Enrollment appointment serves to confirm eligibility thus involvement is not reimbursed. Completed Preliminary Testing (baseline testing, dietary protein efficiency trial, and gut microbiota trial) will be prorated $100 Participants will be paid an additional $100 at the halfway point (week 6) The remaining $800 will be paid at week 13 (after completing the post-training trials and testing) If you decide to participate, you are free to withdraw your consent and discontinue participation at any time. The researchers also have the right to stop your participation in this study without your consent if they believe it is in your best interests, you were to object to any future changes that may be made in the study plan, and/or if you maintain less than 85% compliance for nutrition or activity throughout the study. Further, repeated absence from research sessions (e.g., failing to report to the laboratory at requested times) will also result in study removal.
Your de-identified information and/or biospecimens could be used for future research without additional informed consent. You can request your data and samples be removed from the repository at any point by emailing the research team at genai2@illinois.edu or the principal investigator (contact information on p.1) . Collected samples will not be used for commercial purposes.
Contact the Principal Investigator (contact information on p.1) or the research team leaders, Gena Irwin (genai2@illinois.edu ), if you have any questions about this study or your part in it, or if you have concerns or complaints about the research.
If you have any questions about your rights as a research subject, including concerns, complaints, or to offer input, you may call the Office for the Protection of Research Subjects (OPRS) at 217-333-2670 or e-mail OPRS at irb@illinois.edu. If you would like to complete a brief survey to provide OPRS feedback about your experiences as a research participant, please follow the link
here or through a link on the OPRS website:
https://oprs.research.illinois.edu/ . You will have the option to provide feedback or concerns anonymously or you may provide your name and contact information for follow-up purposes.
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