The Choline Status Study requires you to complete three 2-week long dietary intervention “arms.” An “arm” is a period of time where you consume ONLY the foods and beverages we provide and have visits where we collect information. The foods we provide are primarily frozen meals. After each of these “arms” you will return to your normal diet for a minimum of two weeks.
Each arm has 4 visits with fasting blood draws which will require morning appointments.
The study will also have three days (one in each arm) that may last as long as 4 hours because you will stay at the Nutrition Research Institute to provide a few measures, including a stool sample. Once you have completed all measures including the stool sample you may leave. If you cannot produce the stool sample during the 4 hour time period, you will be given a kit to take home and collect your next stool and return to the NRI.
Your participation in the study will also require multiple urine samples for 24-hour periods at the screening visit and the start of each arm. They will also be collected from Day 4 to 5, Day 11 to 12, and Day 14 to 15 of each arm. You must be willing to eat ONLY the food and beverages we provide for you for two weeks at a time with at least two weeks of your usual diet between the diets we provide for you.
If that sounds like something you are still interested in doing, please read the information below.
Choline (Cho) is an essential nutrient and most American’s diets do not achieve the recommended daily intake. Diets low in Cho are associated with liver and muscle disease, such as fatty liver, and with suboptimal fetal development in pregnant females. It is also known that diets too high in Cho may be associated with increased risk for heart disease.
Currently there is no validated blood test to check Cho status (the total availability of the various forms of Cho needed to sustain optimal function). The purpose of this study is to develop a reliable test for choline status.
Are there any reasons you should NOT be in the study?
• If you are under 17 years old or over 70 years old
• If your weight is outside the range of 132-177 lbs
• If you have a body mass index (BMI) of greater than 30 (if you do not know –you can check it here: https://www.cdc.gov/healthyweight/assessing/bmi/index.html )
• If you consume more than 2 alcoholic beverages per day or more than 14 alcoholic beverages per week
• If you smoke or consume other tobacco products
• If you consume any other illicit drugs
• If you are taking any drugs or medications known to cause damage to the liver or muscle or to alter Choline metabolism, eg. Methotrexate
• If you consume an unusual diet that can interfere with the study or if you have allergies or aversions to foods in the study
• If you consume Choline-containing dietary supplements
• If you have been diagnosed with liver, kidney or other chronic systemic diseases (including diabetes)
• If you have had a liver transplant
• If you are breastfeeding, pregnant, or planning to become pregnant
• If you have been diagnosed with ascites (free fluid in the abdomen)
• If you have an implantable medical device such as a pacemaker
• If you have an abnormality (e.g. cyst) that would confound Fibroscan measurements
• If you are actively participating in another research study that requires you to ingest anything or exercise
• If you perform intense exercise more than 1 hour daily, or perform other intense exercise such as weightlifting beyond simple low weight repetitions
If you are eligible, we would invite you for a screening visit where will conduct a review of your health history, take a blood sample, urine sample if female, complete an ultrasound assessment of your liver and a physical exam to determine if you meet the criteria. You would also sample some of our foods and begin a 24-hour urine sample collection that will need to be returned the next day. If you are found to be eligible based on the screening visit, you will be given kits and asked to provide a stool sample and another 24-hour urine sample that would be collected in the 24 hours prior to your enrollment in the study and brought to your enrollment visit.
You must be able to consume the study diet that may include items such as:
Lean Cuisine Pizza, Lean Cuisine 5 Cheese Rigatoni, Amy’s Enchilada Verde – Spinach and Cheese Enchilada, Amy’s Vegetable Lasagna, Amy’s Pesto Tortellini Bowl, Jimmy Dean Delights Croissant Turkey Sausage Egg Whites & Cheese, Jimmy Dean Delights English Muffin Applewood Smoke Chicken Sausage Egg Whites & Cheese, Banquet Chicken Pot Pie, iceberg lettuce, rolls.
Your participation in this study would include visits that range from 30 minutes (food pickups) to 4 hours per visit. The study involves approximately 17 visits for its completion. However, you may need to visit the NRI more than 17 times to pick up urine kits or if you were to run out of the diet provided to you to consume strictly during the study. Your active participation in this study lasts about six (6) weeks (this excludes the minimum two week washout periods which occur between study arms).
If you think you meet the criteria listed above, and are still interested in participating please let us know and include a good phone number we can use to reach you to complete the telephone screening. Participant compensation for completion of the screening visit is a $50 gift card. Those who complete the study will receive an additional $2000. We look forward to hearing back from you by email or phone to firstname.lastname@example.org or 704-250-5048.