©2016 by UVa Health System. Division of Endocrinology.

FREQUENTLY

ASKED QUESTIONS

Are the pre-study screening tests part of the two-week study?

Pre-screening tests are NOT part of the two week diet study. The screenings are two separate examinations – genetic and general screening – that are used to see if participants have specified gene variants in question and to assess whether or not participants are physically healthy enough to participate in the study.

 

Please allow up to 4 weeks for results to come in. Once results come in, researchers will be in touch.

How long will the study last?

After the genetic and general screening has been completed and participants genetically and physically qualify for the study, participants will enter into the diet part of the study. The study will last for two consecutive weeks, during which participants are given a specially prepped diet for the duration of the study that they must follow religiously. The pre-study screening tests can be done at leisure whenever the participant has time to complete each.

How many hours do I have to put into the study?

Participants are required a total of seven hours of participation for the study, including the pre-study screening tests and the duration of the two-week diet. Below is a breakdown of the hours divided:

30 min - Genetic Screening Test

90 min - General Screening Test

60 min - Follow Up Visit and Food Pick Up

15 min - Follow Up Visit and Food Pick Up

60 min - Follow Up Visit and Food Pick Up

60 min - Follow Up Visit and Food Pick Up

15 min - Follow Up Visit and Food Pick Up

60 min - Follow Up Visit and Food Pick Up

60 min - Follow Up Visit and Results Pick Up

Please Note: all follow-up visit appointments must be made at the same time of day each visit (i.e. Participant A comes for scheduled follow-up visits every Monday, Wednesday, and Friday at 9:00 a.m. each visit). Blood pressure rises and falls based on the time of day; therefore, this procedure of consistent time appointments is used to avoid this diurinal variation in order to focus on our single variable, sodium.

Can I get my genetic results?

Those that fully complete the study are eligible to gain access to their genetic results obtained from the pre-study genetic screening test. Individuals who simply undergo the pre-study tests and do not qualify or have dropped out of the study for health or personal reasons are unable to gain access to their genetic results. 

What kind of food will be provided?

The diet menu provided by the UVA kitchen can be found under the tab Two-Week Diet. The diet has the option of fish, chicken, beef, or vegetarian. Qualified dieticians and chefs are hired to create meals that are tasty and contain the right amount of daily nutrients. Special accommodations can be made by the chef with proper coordination (i.e. for those that are gluten free). Each meal is isocaloric to each participant based off of their BMI. More information on the contents of the menu still must be determined. Please check in periodically.

How and where is the food made?

The food is made at the UVA Hospital kitchen. Each meal is created based on each participant's individual BMI. These isocaloric meals will be available at the CRU for pickup during follow-up visit. Sodium content will be monitored using urine samples to validate that participants stick to the diet provided for them.

Are there any special accommodations made for the diet?

Special accommodations can be made by the chef with proper coordination. Individuals who have special requirements for their meals must let the research coordinator know as soon as possible in order to properly coordinate with the chef. Special accommodations are made for those who are vegetarian or gluten free.

What do I do if I am missing a meal?

About 6-9 meals will be given each visit to last just enough time before the next food pickup visit. It is important that before leaving each visit, you look to see if all the meals are provided.

For those who are missing a meal, please let the clinical research coordinator know as soon as possible. Contact the kitchen with the number provided:  Ciara Marsh (434) 465-9370

Can I still participate if I have low blood pressure?

The only exclusion that deals with the study is high blood pressure. Those with high blood pressure are unable to participate in the study. However, those with normal to low blood pressure are invited to participate. Low blood pressure is not a limiting factor and participants that have it are encouraged to join.

Can I still participate if I have already participated before?

The salt sensitivity study is a study that has been ongoing for 10 years. In August 2016, the UVA Division of Endocrinology and Metabolism received a grant extension for an additional five years from the National Institute of Heath (NIH). It may be possible that individuals who have participated in the study in past 10 years come across this study again. Those who have already participated and are interested in participating again are welcome to join the newly revised protocol implemented for the next five years.

How can you tell if I stray away from the diet?

Our study requires that all participants follow the diet religiously and complete each meal. Isocaloric diets can be monitored by testing sodium content of urine and blood samples collected. If we find that the sodium content is significantly lower or higher than what we are adding in our food, we can terminate participants due to noncompliance or non adherence to their diet.

Do I have to quit smoking in order to participate?

In order to participate in the study, participants cannot smoke cigarettes for two weeks. Completely quitting smoking is not an obligation and certainly not required. However, for the duration of the two weeks, smoking is prohibited in order to minimize confounding variables so research can focus solely on the effect sodium intake has on blood pressure. Smoking cigarettes has a direct effect on blood pressure.  Quitting smoking can have adverse withdrawal symptoms that include increased anxiety, appetite, irritability, and fatigue. If any of these symptoms arise, please notify the clinical research coordinator as soon as possible. Those who are unable to abstain from cigarette smoking for two weeks are not required to stay in the study and may drop out whenever they please.  

Do I have to quit caffeine and/or alcohol in order to participate?

In order to participate in the study, participants cannot drink any beverages outside of what is given in the specially prepped diet for the duration of the two weeks. This includes alcohol or any caffeinated drink such as energy drinks, tea, coffee, etc. The study focuses on sodium intake as the sole variable in the rise or fall of blood pressure. Alcohol consumption decreases sodium levels by not only dehydrating your body but by damaging liver function as well, leading to liver cirrhosis with long-term abuse. Similarly, excessive caffeine consumption causes excessive urination and dehydration of the body resulting in a decrease in sodium levels. Participants are not required to quit either substances completely, but are required to abstain from either for the duration of the two-week diet study. Quitting can have adverse withdrawal symptoms that include increased anxiety, appetite, irritability, and fatigue. If any of these symptoms arise, please notify the clinical research coordinator as soon as possible. Those who are unable to abstain from drinking alcohol or caffeine for two weeks are not required to stay in the study and may drop out whenever the please.  

What happens if I eat food outside of the prepped diet?

The study requires that each participant stick religiously to the diet prepared for them by the UVA kitchen. Participants will undergo three separate 24-hour urine collections as well as periodic urine collection during each follow-up visit. Those who eat food outside of the diet will be excluded from the remainder of the study and results will be terminated. As a result, participants will not receive genetic results of the pre-study genetic screening test nor will they receive the $200 compensation for completing the study.

What happens if I smoke cigarettes or drink caffeine/alcohol while in the two-week diet study?

Drinking alcohol and/or caffeine and smoking cigarettes directly effects blood pressure by increasing or decreasing sodium levels of the blood plasma. Because this study focuses on a single variable, sodium intake, it would be wise to avoid such instances  to obtain accurate data that is coherent with the truth. It is also important to note that all participants will be receiving their personal physical response - a report at the conclusion of their participation that states their susceptibility to salt and its effect on their personal blood pressure. Therefore, smoking on the study will affect not only the results of the group but individual results as well.

What do I receive for participating in the study?

Participants in the study will receive...

1) relief from grocery shopping and cooking for two weeks

2) genetic results obtained from pre-study genetic screening test. Individuals will obtain knowledge on their predisposition to developing hypertension later in the future.

3) satisfaction in contributing data to the future solution to essential hypertension on a molecular and cellular level.

4) a $200 compensation for full completion of the study.

What risks are involved in the study?

Although unlikely, there is the possibility of some side effects that must not be taken lightly. Risks include:

1) Withdrawal symptoms

Participants are not required to quit smoking and drinking caffeine/alcohol completely, but they are required to abstain from either for the duration of the two week diet. Withdrawal symptoms include an increase in irritability, sleepiness, anxiety, and appetite. 

Participants that begin to feel withdrawal symptoms, please call the clinical research coordinator as soon as possible.

2) Heart attack/stroke symptoms

As stated before, sodium intake during this study is used only to see how sodium intake affects blood pressure. An increase of blood pressure leads to the degradation of our arteries and heart leading to deaths that involve heart attacks or strokes. Although there is a minimal chance of experiencing stroke or heart attack, all participants who begin to feel symptoms should call 911.

Participants will undergo a genetic testing in which genetic material will be collected including urine and blood sample collections and will stay in a secure server and will be de-identified to protect participant personal information.

I workout daily. Am I still allowed to work out while on the two-week salt diet?

Physical exercise plays a role on sodium levels of blood plasma as well. When individuals engage in physical activity, they begin to sweat. Sweat is small amounts of water containing ammonia, salts, sugars, and urea that is excreted through skin pores. Therefore, the more an athlete sweats the more their sodium levels diminish. It is for this reason we ask participants not to engage in strenuous activity for the duration of the two weeks in efforts to avoid data alteration. Participants may engage in light activity such as the recommended daily exercise; however they cannot undergo highly active engagements such as training for a triathlon.