Nutrition Research Study for Infants Nine Months and Younger
What is the purpose of the study?
A nutritional study of soy equol (a helpful nutritional substance) and its production in infants. This study is related to the health benefits of soy equol.
Who will be included in the study?
Healthy infants up to 9 months of age may be eligible to participate.
What is involved?
This study lasts for 2 ½ years and includes 7 visits. For each visit:
- A diet record is kept of all your child eats and drinks for 3-days
- Infants/children drink 8 oz of soy infant formula a day for 4 days
- A dirty diaper and urine sample is collected
- One blood sample is collected at 3 years of age
What are the benefits?
The only direct benefit your child may receive from participating in this study is to learn whether they are able to make equol from soy, and equol has several health benefits. However, the biggest benefit is that your child may be helping other children. Clinical studies are essential in finding new and improved treatments and diagnostic tools.
Will I Get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
When a blood sample is taken there is risks of fainting or infection, but this is unlikely to occur.
What is the compensation?
The parent will be compensated $50.00 for each visit and the child will receive a gift certificate of equal value to Wal-Mart or Target.
Who should I contact for more information?
Dr. Nadine Brown
Cincinnati Children's Hospital Medical Center
Department of Pathology, Clinical Mass Spectrometry
3333 Burnet Avenue, MLC 7019
Cincinnati, OH 45229-3039
Phone: 513-636-4686
Nadine.brown@cchmc.org
