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.edu

Information Regarding the
Nutrition Portion of the ProBP Study

1. 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 Visit

You 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 packets

At your Randomization Visit and at each Baseline Visit 2

You 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 Supplement

You 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.

Tips:

• Study supplement can be mixed into water, orange juice and other juices, soft drinks, smoothies, other beverages. When mixing your study supplement into water or another beverage, mix with cold water first in order to ensure that your final product will be smooth.

• For hot beverages, the study supplement should be mixed with cold water and then heated in order to avoid a lumpy product. Handle hot beverages with care.

• Some recipes call for frozen whipped topping or sherbet. Substituting ice cream or yogurt in place of these will cause beverages to be less smooth.

• When preparing beverages, if the final product is too thick, add additional fluid until the desired consistency is attained. You will not need to add more water for a single supplement packet than your ProBP mug will accommodate. For beverages, if the final product is too foamy, add a few drops of vegetable oil or allow your drink to sit for 5-10 minutes before consuming

Blender

Instructions:

• Pour 8 ounces of cold water into the blender.

• Pour the contents of the study supplements into the blender. Use the entire packet of supplement.

• Mix for a couple of seconds at a time by pulsing until blended.
Do not over blend.

• Add 1-2 blocks of ice and blend for a couple to seconds by pulsing.

• Add flavor packet, fruit etc and blend for a few seconds until completely mixed.

• Drink.

Adding Supplement to Food Items

• Study supplement can be mixed into food items such as casseroles, soups, oatmeal, pancakes, side items, and other dishes.

• When mixing supplement into recipes, casseroles, and side dishes, it is important to mix the study supplement with the portion of the food item that you will be consuming. Supplements should not be added to a dish that will be shared by several people; you should always add the study supplement to the portion you yourself will be eating.

Baking

• Please note that each of the baked goods recipes contains 1 packet of your study supplement.

This is _ of your daily study supplement requirement. Recipes can be doubled to contain all your study supplement for the day, but you must consume the entire recipe yourself in one sitting or over the course of one day.

• The amount of flour required for baked goods may vary depending on several factors; add flour in small increments (_ cup at a time initially, then in smaller amounts as you approach the amount given in the recipe) until desired consistency is achieved (not too sticky but not too dry).

• Recipes can be increased so that baking for more than one day can be done all at the same time; be sure to keep in mind, though, that you should always consume a total of 2 packets of study supplement per day.

Maintaining Your Usual Food Intake

Your total energy intake should remain constant throughout the study. As a result, we ask that you substitute a small amount of food with your study supplement. For example, if you normally consume yogurt or a granola bar for a snack, please consume your study supplement instead. Each packet of study supplement contains about 100 calories, and the flavor packets contain about 20 calories each.

Aside from this slight change in your food intake, no other changes in diet should occur.
It is important that you maintain your fluid intake.

IF YOU BELIEVE YOU ARE EXPERIENCING SIDE EFFECTS, OR IF YOU HAVE ANY OTHER QUESTIONS OR CONCERNS, PLEASE CONTACT THE PROBP STAFF; STAFF MEMBERS WILL ADVISE YOU ON WHAT TO DO. OUR TELEPHONE NUMBER IS 504-988-4390, OR YOU CAN REACH US VIA E-MAIL AT PROBP@TULANE.EDU

Instructions for Completing Your Supplements Calendar

1. You will receive a calendar on which to log your daily study supplement consumption. We encourage you to fill out this calendar as completely as possible.

2. We will provide you with a magnetic appointment card holder; this may be used to keep your supplement calendar on the refrigerator door, in view, so that taking and keeping track of your study supplement will be easier to remember.

3. This calendar includes two sections for each day, one for each of the two supplement packets you should consume every day.

4. In the space provided, please fill in the time of day you had your supplement (am or pm) and how much of the supplement you consumed at that time (for example, all, one half, 90%).

5. The calendar also contains a space for comments, which you can use for yourself as a reminder of how you prepared your supplement that day, for example, or for questions or comments you have for study staff at your next visit.

6. You do not have to take the supplement at the same time every day, but doing so may make it easier for you to remember.

Please bring your completed calendar with you to your next study visit!

Supplement Recipes

BEVERAGES

From DuPont Protein Technologies, St. Louis, MO

Orange Julius

8-10 ounces cold water
1 packet study supplement
1 orange dream flavor packet
_ cup fat free or low fat frozen whipped topping
Directions: Mix water and study supplement together and blend in remaining ingredients. Makes 1 serving.
Creamy Mocha Delight
8-10 ounces cold water
1 packet study supplement
1 chocolate deluxe flavor packet
1 teaspoon instant coffee
_ cup fat free or low fat frozen whipped topping
_ cup ice

Directions: Mix water and study supplement together and blend in remaining ingredients. Makes 1 serving.

Vanilla Fruit

8-10 ounces cold water
1 packet study supplement
1 French vanilla flavor packet
_ cup frozen fruit
Directions: Mix water and study supplement together and blend in remaining ingredients.
Smoothie
8-10 ounces cold water
1 packet study supplement
1 flavor packet
_ cup frozen whipped topping
_ cup ice

Directions: Mix water and study supplement together and blend in remaining ingredients.

Creamy Vanilla

8-10 ounces water
1 packet study supplement
_-1 teaspoon vanilla extract
Sweetener to taste

Directions: Blend ingredients; pour and serve over ice.

Cranberry Splash

1/3-1/2 cup water
1/3-1/2 cup cranberry juice
1 packet study supplement
Sweetener to taste
Directions: Blend ingredients; pour and serve over ice.
Almond Iced Coffee
8-10 ounces cold water
1 packet study supplement
1 teaspoon instant coffee
1 tablespoon almond flavor coffee creamer
Sweetener to taste

Directions: Blend ingredients; pour and serve over ice.

Rainbow Icee

_ cup water
1 packet study supplement
_ cup ice
_ cup rainbow (or other) sherbet
_ cup ice

Directions: Blend study supplement with water. Add remaining ingredients and blend until smooth.

Fruit and Cream

2/3-3/4 cup water
1 packet study supplement
1/2 cup frozen fruit
_ cup frozen whipped topping
_ cup ice
Sweetener to taste

Directions: Blend study supplement with water. Add remaining ingredients and blend until smooth.

Creamy Iced Coffee

_ cup water
1 packet food ingredient
flavored coffee of choice
_ cup frozen whipped topping
_ cup ice

Directions: Blend study supplement with water. Add remaining ingredients and blend until smooth.

Hot Mocha Drink

12 ounces hot water
1 packet study supplement
chocolate flavor packet
cappuccino flavor packet

Directions: Add powder to water and mix well with spoon. Add flavor packets and mix again.

Almond Coffee

8-10 ounces water
1 packet study supplement
1 teaspoon instant coffee
1 tablespoon almond flavored coffee creamer
(or other flavored creamer of choice)
Sweetener to taste

Directions: Add coffee and study supplement to cold water. Heat product in microwave; handle with care, as product will be hot. Add flavored coffee creamer and sweetener to taste.

French Vanilla Coffee

8-10 ounces water
1 packet study supplement
French vanilla flavored coffee (or other flavor of choice)
Sweetener to taste

Directions: Add coffee and food ingredient to cold water. Heat product in microwave; handle with care as product will be hot.

BAKED GOODS

Please note that each of the baked goods in the recipes below contains 1 packet of your study supplement.

This is _ of your daily study supplement requirement. Recipes can be doubled to contain all your study supplement for the day, but you must consume the entire recipe yourself in one sitting or over the course of one day.

The amount of flour required for baked goods may vary depending on several factors; add flour in small increments (1/4 cup at a time initially, then in smaller amounts as you approach the amount given in the recipe) until desired consistency is achieved (not too sticky but not too dry).

Recipes can be increased so that baking for more than one day can be done all at the same time; be sure to keep in mind, though, that you should always consume a total of two packets of study supplement per day.

Italian Flat Bread

Adapted from the Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign © 1995

_ c-1 c flour
1 packet study supplement
_ teaspoon salt
_ teaspoons sugar
Dried rosemary (optional)
_ package active dry yeast
_ teaspoon vegetable oil
_ c plus 2 tablespoons lukewarm water (100-105 degrees F)

1. Mix flour, study supplement, salt, sugar, rosemary, and yeast. Add oil to the water in large mixing bowl of an electric mixer. Add dry ingredients to liquid gradually, beating well.

2. Turn the dough onto a floured board and knead until smooth (8-10 minutes). Alternatively, a dough hook attachment for the mixer may be used to complete the kneading process. Beat for 3-5 minutes or until a smooth dough forms and clings to the hook in a solid mass.

3. Divide dough into 2 portions (for one supplement packet). Roll out each portion to 5-inch diameter and place on baking sheet lightly sprayed with no-stick spray. Prick surface with fork at 1-inch intervals. Let rise uncovered in warm place (85-95 degrees F) for 30 minutes. Preheat oven to 400 degrees F.

4. Bake in a preheated oven at 400 degrees F for 14 minutes or until golden brown.

Velvet Muffins

From DuPont Protein Technologies, St. Louis, MO
1 packet study supplement
_ cup all purpose baking mix
1/3 cup sugar
1 egg
1 tablespoon vegetable oil
_ teaspoon vanilla
_ cup milk

Directions: Heat oven to 350 degrees F. Beat all ingredients on low speed for 30 seconds, scraping bowl. Pour into lined muffin pan. Bake for 17-25 minutes or until golden brown. Makes 4-5 muffins. Do not over mix batter.

Velvet Fruit Muffins

From DuPont Protein Technologies, St. Louis, MO
1 packet study supplement
_ cup all purpose baking mix
1/3 cup sugar
1 egg
1 tablespoon vegetable oil
_ teaspoon vanilla
_ cup milk
_ cup fresh or frozen fruit

Directions: Heat oven to 350 degrees F. Beat all ingredients on low speed for 20 seconds, scraping bowl. Pour into lined muffin pan. Bake for 17-25 minutes or until golden brown. Makes 4-5 muffins. Do not over mix batter.

OTHER FOODS

Pancakes

From DuPont Protein Technologies, St. Louis, MO
1 packet study supplement
_ cup all purpose baking mix
_ cup milk
1 egg

Directions: Stir ingredients until blended. Cook until edges are dry, turn, and cook until golden brown. Add 2 tablespoons additional milk if batter is too thick.

Oatmeal

From DuPont Protein Technologies, St. Louis, MO
1 individual size packet instant oatmeal
_ packet study supplement
2/3-1/2 cup water

Directions: Empty packets into microwave safe bowl. Add water and stir. Microwave on high for 1-2 minutes; handle with care as product will be hot.

Do you have a recipe
beverage or baked good recipe?

We would love to hear from you!

• email us your recipe •