ProBP - Protein and Blood Pressure Study What is the Protein and Blood Pressure Study?The Protein and Blood Pressure Study, or ProBP for short, is an important research project designed to determine if taking a soy or milk supplement every day will lower blood pressure. How would I know if I am eligible?We are looking for healthy volunteers, 22 years or older, with prehypertension or mild hypertension who are not currently using antihypertensive medications. We will take your blood pressure over the course of 2 weeks and ask you some questions about your health to see if you qualify. What would be required of me if I qualify?If you qualify and you agree to participate, you will be invited to take part in a 2-week trial to give you a chance to try taking the supplements every day. If you can complete this 2-week trial and are willing, you may qualify for the main study. The main study lasts for approximately 30 weeks. While on-study you will be asked to take a soy protein supplement for 8 weeks, a milk protein supplement for 8 weeks and a complex carbohydrate supplement for 8 weeks. You will not know which one you are receiving at the time. In between each “phase” you will have a 3 week period where you will not take any supplements. During the main study, you will also be asked to come into the clinic for study visits where we will check your blood pressure, your cholesterol, your blood sugar as well as some other tests. Our dietitian will also ask you questions about your food intake. Why should I join the ProBP Study?If you qualify and you choose to participate in ProBP you will receive:
• FREE blood pressure checks
• FREE cholesterol profiles
• FREE blood sugar & insulin profiles
• PLUS the satisfaction of participating in an important project to benefit you,
your family and friends.You will also receive $200 upon your completion of the study.
For more information contact us at (504) 988-4390 or at probp@tulane.eduInformation Regarding the Nutrition Portion of the ProBP Study1. 24-hour Dietary Recalls You will be asked to complete two 24-hour dietary recalls, one at the clinic and one over the telephone, at the end of screening and of each study phase. The in-clinic recalls will be part of your already scheduled clinic visit. These are used to gather data about your usual dietary intake. 2. Study Supplement You will be asked to consume study supplement for a 2-week “practice” period prior to beginning the study, and then for three 8-week periods during the study. You will receive a different study supplement during each period, in random order. Between each 8 week study phase, you will have a 2-3 week period of time when you are not on any supplement at all. Once this “washout” period is completed, you will go on to the next 8 week phase of the study during which you will go back to taking study supplement. Thank you for participating in the ProBP Study. At your Run-In VisitYou will receive: • a 16 oz study mug with spoons
• a ProBP refrigerator magnet that holds your appointment card
• a study calendar
• a 2-week supply of study supplement and flavor packetsAt your Randomization Visit and at each Baseline Visit 2You will receive: • a study calendar
• a 8-10 week supply of study supplement with flavor packets Taking your Study Supplement 1. Take 2 packets of study supplement EVERY day of the 2-week run-in period and of each 8 week intervention period you are assigned. You will be assigned to one 2-week run-in period and a total of three 8 week intervention periods, each with a different study supplement. It is very important to take the study supplement as directed, twice per day every day. 2. At the end of the 2 week run-in period and of each 8 week period, please return all unused study supplement to the study site; do not keep packets, use old packets, or substitute old packets for new ones in an effort to use them up. You will receive a DIFFERENT study supplement for the two week run-in period and for each 8 week period, so it is important that you take the packets you are given for each period. 3. Please retain and return the used/empty packets to us; we count them for tracking purposes. 4. You will also receive a supply of flavor packets for each study period. These flavor packets can be mixed with the study supplement and water or another beverage. You are able to choose the flavor(s) you want to try. You can also add your own additions for flavor, including fruit or honey. 5. You can take one packet in the morning and one at night, or you can take your supplement all at one time each day. Either way, you must consume 2 entire packets every day.
6. You will receive recipes and other ideas for preparing your study supplement. You can use any of these recipes, or devise your own; but you must consume the entire recipe in one sitting or over the course of one day in order to consume all required study supplement for the day. Mixing Your Study SupplementYou can mix your supplement several ways: By hand, in your mug with a spoon Instructions: • Pour 8 ounces of cold water into the mug • Pour the contents of your study supplement packet into the mug. Use the entire packet of supplement. • Stir. Some supplements may need more mixing than others and could require as much as ten minutes to completely mix when stirring by hand. • If you choose to use the flavor packets, pour the contents of the flavor packet into the mixture and stir. | 
