The purpose of this study is to determine if stopping the stress induced increase in
inflammation will prevent sodium retention which in turn increases blood pressure. Each
subject will test two separate times. One week, they will be taking a daily dose of
mycophenolate mofetil (MMF), the other week they will be taking a placebo.
This study will involve a screening visit and two testing weeks over an approximate 3 week
period (this includes a one week "washout" period).
Each testing week will have a 3 day salt-controlled diet prior to testing and an approximate
3-hour testing period on Day 4. The 3-hour testing period will include 10 minutes of a
baseline rest, 45 minutes of mild stress (competitive video game), and 45 minutes of a
recovery rest. A total of 4 blood and 4 urine samples will be collected during the 3-hour
period. Each blood draw will consist of about 7 teaspoons for a total of 28 teaspoons per
During the screening and testing, I will be asked to take the MoCA (the Montreal Cognitive
Assessment) test in order to measure cognitive thinking after stress. It is a brief
30-question test which takes around 10 minutes to complete. It measures different types of
cognitive abilities, including orientation (the approximate position of something/someone),
short-term memory (remember information for a short period of time), executive function
(planning and problem solving), language abilities (assign appropriate names to appropriate
items), and visuospatial ability (determine distance from one object to another). Each
question is awarded a particular number of points depending on the accuracy of the answers
given. We will be looking to see if the total number of points earned changes in response
before and after stress.
Screening Visit: I will come to the GPI or the CRU for a screening visit that will last
about 90 minutes. The study will be described in detail and an informed consent will be
obtained. Vital signs will be taken (blood pressure, height, weight and BMI - Body Mass
Index. A health history and a limited physical exam will be conducted by Dr. White (or a
physician delegate) to insure that it is safe for me to participate in the study. A blood
sample will be obtained from me to make sure nothing is wrong with my kidneys or liver or
have any other chronic illness. If all lab work returns with no abnormalities, then I will
be cleared to participate in one of the crossover studies.
I will also select my food and drink items from a food menu for the 3-day diet prior to
testing. The items I select will give me enough to eat and drink for the 3 days. All food
and drink items will be packed in coolers that I will be responsible for picking up and
dropping off daily. I am not to eat any food or drink item(s) other than those provided,
except for water. To make sure that I am following the diet, I will be asked to return all
of my food wrappers and drink containers to the GPI or CRU. I will also be asked to collect
an overnight urine sample each night so that they can see how much salt I am taking in each
day. My testing weeks will also be scheduled at this visit.
The last thing that I will be asked to do for the screening visit, is to take the MoCA test
which will take approximately 10 minutes. Someone from the research team will instruct me as
to what to do for each question and I will answer each one to the best of my ability.
Testing Week One: The week prior to my scheduled testing week, I will pick up my food
coolers for the 3 day study diet along with my 7 ½ day prescription of either the MMF or the
placebo. In addition, if I am female, I will have to give a urine sample so that a pregnancy
test can be performed to make sure I am not pregnant before I start taking the medication.
Should the pregnancy test show positive, I will not be allowed to continue participating in
the study. I will take the study medication (either MMF or a placebo) 500 mgs twice a day
for the 71/2 days as instructed, taking my last dose the morning of testing at GPI.
The coolers will contain the food and drink items that I selected previously at my screening
visit. I will also receive the overnight urine collection bottles. During the diet phase of
testing, I will collect a urine sample before I go to bed each night and record the time
(write the time on the bottle). I will also collect a urine sample as soon as I wake up each
morning and record the time. I will be returning the urine collection bottles and food
coolers to GPI or CRU starting on the second day of the diet phase. This means that I will
return my Monday cooler and urine collection bottle on Tuesday (Day 2). I will then return
my Tuesday cooler and collection bottle on Wednesday (Day 3). On Thursday (testing day), I
will bring back my Wednesday cooler and urine collection bottle. During the diet phase of
the study, if I am female, a pregnancy test will be performed on each overnight urine sample
to ensure that I am not pregnant.
On testing day, I will bring with me my Wednesday cooler and overnight urine sample and will
be given breakfast before testing begins. Again, if I am female, a pregnancy test will be
performed on my last (Wednesday) overnight urine sample to ensure I am not pregnant. I will
be taken to a private room for testing and placed into a comfortable reclining chair. A
nurse/phlebotomist will insert a small needle attached to a plastic tube called a catheter
into a vein in my hand or arm. This procedure will allow the nurse/phlebotomist to collect
the 4 blood samples over the 3-hour testing period. The needle stick may cause some
temporary pain and may result in a black and blue mark. A device that automatically takes
blood pressure will then be put on the opposite arm. I will also be given water in order to
take my last dose of medication before testing begins and to sip on during the duration of
testing. During the first 10 minute baseline rest period, I will relax in a reclining chair.
I can listen to music, read a book or magazine or watch movies to pass the time. My blood
pressure will be taken before and after this 10 minute rest period. Once the baseline rest
period is over, a blood and urine sample will be collected.
During the stress period, I will play a video game against another subject for 45 minutes.
My blood pressure will continue to be measured every 10 minutes. I will also continue to sip
on water during this time. At the end of the game, another blood and urine sample will be
collected. I will then be asked to complete the MoCA test a second time. It will be the same
questions I was asked during the screening visit. A research team member will instruct me
again as to how to answer each question and I will answer them to the best of my ability.
The last 45 minute recovery period of relaxation will be the same as the first (reading,
listening to music or watching movies). My blood pressure will continue to be taken every 10
minutes. Once the 45 minutes has ended the last blood and urine sample will be collected and
the testing day will then be completed.
Testing Week Two: The procedures for the Testing Week 2 are the same as Week 1. I will be on
the controlled salt diet for 3-days, will take the study medication twice a day and will do
the 3-hour testing on the 4th day. Like the first week, there will be 10 minute baseline
rest period, 45 minutes stress period of the competitive video game and 45 minutes recovery
rest period. Blood and urine samples will also be collected and I will be asked to take the
MoCA test just like during Week 1 testing. Approximately 56 teaspoons of blood will be
collected during the entire study. This blood will be used to examine how biochemical
factors (stress hormones) relate to blood pressure and cardiovascular (heart) health. The
DNA (genetic material) from the blood will be studied for genes relating to high blood
pressure and other genes that may be related to the risk of cardiovascular disease. The
blood, urine and DNA samples may be stored and used for other similar studies by Dr.
Harshfield, Dr. Harris and Dr. Dong. The genetic results from these studies will not be told
to myself and will not be given to any doctor or other individual.
- African American
- Not pregnant or breastfeeding
- Does not have high blood pressure
- Currently not taking any medications that may effect blood pressure
- Pregnant or breastfeeding
- Has High Blood pressure
- Taking medication that may effect blood pressure
- Failed Screening blood sample lab results - reviewed by study designated doctor