1. Joanna Radziejowska MS, RD, LDN Nutrition Research Manager Harvard Medical School CTSC

2. BIDMC Site Director Associate Site Director Nurse Manager Nutrition Research Manager Program Manager Administrative Coordinator Practice Coordinator Research Registered Dietitian Research Coordinators Research NursesNutrition Aides Patient Care Technicians Diet Technicians Laboratory Assistant Chief Academic Officer SVP Research BIDMC CEO & President HCRC Director Principal Investigator & Dean of Translational Research Dean HMS BIDMCHarvard Catalyst Harvard-Thorndike Clinical Research Center

3.  There are four CRC sites and one community CRC site within the Harvard University CTSC: ◦ Beth Israel Deaconess Medical Center ◦ Brigham & Women’s Hospital ◦ Boston Children’s Hospital ◦ Massachusetts General Hospital

4.  Open 24/7  Inpatients – 8 beds  Outpatient  Specialized rooms: ◦ Dental room ◦ Cognitive Testing Laboratory ◦ SAFE Laboratory ◦ DXA room ◦ Transcranial Magnetic Stimulation

5. Administration Nursing Staff Unit Coordinator Laboratory Support Assistant Nutrition Staff RDs Diet Technician Research Nutrition Aides Research Assistants Medical Research Officers

6. CRC Metabolism and Nutrition Research

7.  Protocol Development ◦ Assistance with protocol development, including grant preparation. ◦ Literature research into drug-nutrient interactions. ◦ Evaluation of best practices for gathering study-specific nutrition information. ◦ Identification of particular foods that meet a study's nutritional specifications. ◦ Development of nutrient-specific screening and assessment materials. ◦ Evaluation of methodology(-ies) for assessing population-specific changes in metabolic markers. ◦ Budget projections for nutrition services.

9.  Metabolic Kitchen Services: ◦ House Meals/Snacks:  In protocols for which energy, nutrients, or specific foods are not controlled, the diet order may be "House." ◦ Weighed/Controlled Nutrient Meals:  Meal plans are calculated to meet specific nutrient levels defined by the research protocol. Meal plans can be controlled for macronutrients (e.g., carbohydrate, protein, fat) and/or micronutrients (e.g., sodium, potassium, magnesium), glycemic index, or other study specifications.

11.  Metabolic Assessment ◦ Anthropometrics (height, weight, skin fold, and circumferences):  RDs perform various anthropometric measurements using techniques and methods described in NHANES III ◦ Bioelectrical impedance analysis (BIA) for hydration status and body composition ◦ Dual energy x-ray absorptiometry (DXA) for bone mineral density and body composition ◦ Bod Pod:  body composition assessment ◦ Energy expenditure and nutrient utilization using indirect calorimetry ◦ Exercise tolerance testing and exercise-related fitness

12. Skinfold Thickness Measurement Waist Circumference  Measures subcutaneous fat, assumes this represents a % of total body fat  Can measure change through time  Reliability is based on intra and inter operator error

13. Bioelectrical Impedance Analysis  Based on conductive/dielectric tissue ◦ Tissue with high water content allows movement of current  Can determine total body water, and body composition  Reliability: +/-5% depends on hydration  Portable

14. Dual-energy X-ray Absorptiometry  Developed to determine bone density  Considered a gold standard for Body Composition  4 compartment model ◦ bone, muscle and organ, fat, water

16. Bod Pod Uses the principles of whole-body densitometry to determine body composition Density = Mass/Volume Scale measures mass & Bodpod measures volume Uses air displacement plethysmograpy to measure fat & fat free mass in adults and children Test time is ~10-15 minutes with 2 minutes inside the BodPod

17. Measures O 2 consumption and CO 2 exhaled 1.Resting Energy Expenditure 2.Respiratory Quotient 3.Macronutrient Consumption 4.Maximum O 2 Consumption

19.  Nutrition Counseling and Education ◦ Single or multiple sessions with individual subjects ◦ Telephone consultations ◦ Educational classes ◦ Internet-based follow-up and monitoring

20. Nutrient Intake Collection and Analysis ◦ Based on specific aims, the RDs can help investigators select the appropriate tools, collect and analyze nutrient intake data.  Food intake records  24 H recall  Food frequency questionnaires  Nutrition Assessment ◦ Does the subject meet the inclusion/exclusion criteria? ◦ Is the subject willing to maintain their diet for the duration of study? ◦ Does the subject understand the constraints of the

21. To investigate possible mechanisms of weight loss using the medication Exenatide (Byetta). The long term patterns of weight loss among individuals who have robust (>5%) early weight loss with exenatide will be studied.  Visit 1 (Screening): meal and RD -BIA and anthro  Visit 2 (Week 0): test meal and RD -5x RMRs, BIA and anthro  Visit 3: meal provision and RD- BIA and anthro  Week 4, 8, 16, 20, 28, 32, 36, 40, 44, 48: meal and RD- 1x RMR, BIA and anthro  Week 12, 24, 52: test meal, regular meal and RD -5x RMRs, BIA and anthro.  5%, 10%, 15% visits: meal and RD:1x RMR, BIA and anthro  Visit: month 3 & 6 follow up: RD- BIA and anthro

22. To examine change in body weight changes, resting energy expenditure, body composition, glycemic, metabolic markers, and food intake in individuals with type 2 diabetes and overweight/ obesity treated with the SGLT2 inhibitor canagliflozin (Invokana)  Visit 1 (Screening): ◦ Kitchen: Provide standard breakfast of cereal 2% milk, a piece of fruit, and a muffin ◦ RD: -Iliac waist circumference  Visit Enrollment visit (Week 0, week 18): ◦ Kitchen: Provide standard breakfast or lunch depending on time of day. ◦ RD: -Iliac waist circumference; obtain DXA body composition and visceral adiposity analyses; 1 RMR (20 minutes); conduct a 24-hour food recall, analyze 24- recall for major macronutrients and kcal  Visit (Week 2, 4, 8, 12) ◦ Kitchen: Provide standard breakfast or lunch depending on time of day. ◦ RD: -Iliac waist circumference; obtain 1 RMR (20 minutes); conduct a 24-hour food recall; analyzed 24 hr Recall for major macronutrients and kcal

23.  Screen: ◦ Kitchen: meal ◦ RD: menu preferences, RMR and diet education, Waist-Hip-Iliac waist  Day A (Standard Cold Exposure) ◦ Kitchen: meal night before and after testing ◦ RD: RMR at 8:am, Waist-Hip-Iliac waist, 2nd RMR will be performed (cold room in Shapiro 419), DXA scans: (body composition only)  Day B, Day C ◦ Kitchen: meal night before and after testing ◦ RD: RMR at 8:am, Waist-Hip-Iliac waist, RMR # 2 at CRC

24. Study the effects of repeated exposure to sleep disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep is shortened and disrupted, followed by a single night of recovery sleep) on inflammation, mood, and pain processing.  18-night inpatient stay: DAY 1 and DAY 18, ◦ RD: Design diet based on food preferences and caloric needs for duration of the stay.  Diet: ◦ Controlled for macronutrients (15% pro, 30% fat, 55% CHO), electrolytes (3 gm Na, 3 gm K, adjusted for calories), and fluid. No simple sugars, No caffeine and no chocolate. REE X 1.4 activity factor (calculated by Harris- Benedict) = calorie level of diet. Calories and macronutrients to be divided 30% at meals and 10% at evening snack. Weigh back all foods and report to RD.