Clinical Research Details

Clinical Research

Safety and Efficacy of BIO-101 175 mg b.i.d. and 350 mg b.i.d. 26 Week Oral Administration to Patients Suffering from Age-related SARcopenia, Including Sarcopenic Obesity, Aged >65 Years and at Risk of Mobility Disability. A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)

Study Description

To evaluate the effects of two different daily doses of BIO101 compared to a placebo product on your mobility functions measured by recording speed during a 400 meter walk test (about 438 yards). The study drug, BIO101, is in the form of a capsule. The corresponding placebo is in a similar capsule form but with no active ingredient. This study is a randomized, double-blind study. Randomized means that you will be assigned by chance (like drawing straws) to receive either active BIO101 or the placebo (a capsule that does not contain any active study drug) by chance.

All subjects participating in this study have been selected because they have sarcopenia. Your participation in the study will last about 7 months (a screening period plus a 6-month treatment period) and will include 4 visits. The study includes a screening visit, an inclusion visit, and an evaluation period. A telephone interview will be carried out in Month 5, and full visits will be performed in Month 1, Month 3, and Month 6 or during the “end-of-study” visit (the early termination visit if you stop the study before the 6 months). During the 8 weeks prior to the first administration of the study drug, you will participate in the screening visit. During this visit, you will receive full information about this study and you may discuss all of its aspects with the study doctor. If you agree to participate in this study, you will sign and date this document. During the treatment period, you will be asked to avoid being inactive and to maintain physical activity for at least 30 minutes per day, at least 5 days per week. Physical activity may be walking, shopping, gardening, doing housework, and light exercise (at home or outside) only if you are in the habit of doing these exercises.

Open Enrollment

Contact Name: Kamala Weldon
Contact Phone: (904) 244-4691
Contact Email: kamala.weldon@jax.ufl.edu

Investigators


Principal Investigator
Joe M. Chehade, M.D.
Medicine

Sub Investigator
Ravindra Maharaj, M.D.
Medicine