The Food For Thought Study is a research program for a Medical Food intended for dietary management of individuals with Mild to Moderate Alzheimer’s Disease
Ketones are products of fat metabolism produced in the liver as a natural response to starvation and carbohydrate restriction. They are an important source of energy when dietary glucose (sugar) is not available.
Previous research studies have shown that prolonged fasting or consuming a ketone producing diet may have benefits for people with epilepsy, Alzheimer’s Disease, Parkinson’s disease and mild cognitive impairment. However, providing ketones through changes in diet can be hard.
Researchers are looking for ways to incorporate ketones into the diet. One way is through a medical food for use under medical supervision. In this study, a medical food containing a ketone ester called tri-betahydroxybutyrin will be tested. The purpose of this study is to look at the safety and bioavailability (the amount of the product in your body), and assess the potential effectiveness of tri-betahydroxybutryin when consumed three times daily with a food or beverage for the dietary management of subjects with mild to moderate Alzheimer’s disease.
STUDY SPECIFICS (Q&A)
Q. How is the medical food provided?A. As a liquid that is mixed into a juice drink, lemonade, iced tea, butterscotch or chocolate pudding, three times a day.
Q. Are there any side effects?A. In 2016 this product was determined as “generally recognized as safe” or GRAS, based on scientific procedures by an independent panel of scientific experts. However, as with any medication, over-the-counter supplement of nutritional product, this medicinal food may cause side effects in some people such as mild gastrointestinal issues.
Q. How long is the study?A. Approximately 52 days
Q. How many visits with the study team?A. Six. All the Great Lakes Clinical Trials office at the Lutheran Home
Q. What happens at the study team visits?A. The Great Lakes Clinical Trials study team will assess general health through procedures such as physical exams and blood draws. You will also be asked to complete a series of memory tests and questionnaires
Q. Are there any costs to participate?A. You will not be charged to be in this study and there are no extra costs. You will not have to pay for the medical food, study visits, or procedures that are part of the study.
Q. Is there compensation?A. You will receive up to $450 for your participation. ($75 for each of the 6 visits with the study team)
WHO CAN PARTICIPATE?
1. Men and women over the age of 50, who have been diagnosed with mild to moderate Alzheimer’s disease
2. Participants may be outpatients or residents of the Lutheran Home in Arlington Heights
3. Participants cannot have the following conditions:
- Type 1 or Type 2 Diabetes
- Any neurologic disorder that could produce cognitive deterioration including, but not limited to, Parkinson's disease, stroke, or other forms of dementia
- Active cancer in the past 5 years (other than non-melanoma skin cancer)
4. Other criteria may apply and can be discussed with a Great Lakes Clinical Trials team member.
If you are interested in joining this trial, click on the "On Line Survey" button below to provide your contact information. One of our staff will be in touch with you to conduct a short phone screen to determine your eligibility. Otherwise, you can call our center directly at (773) 275-3500 to speak with one of our staff today.