NIH awards $3 million grant to study synbiotic medical food for bone health in older women

The NIH/National Institute on Aging has awarded a R01 $3 million grant to study the impact of a probiotic/prebiotic (synbiotic) medical food developed by Solarea Bio on maintaining bone health of older women.

The study will support an 18-month clinical trial of a synbiotic medical food in 220 older women to test whether it maintains lumbar spine bone mineral density (BMD) with aging.

Grant recipients are Hebrew SeniorLife, USDA HNRCA at Tufts University, Maine Medical Center Research Institute, and Solarea Bio.

"There is an unmet need for safe and effective dietary interventions for the metabolic processes underlying bone loss," said Dr. Shivani Sahni, PhD, who is an associate professor of medicine at Harvard Medical School, associate scientist at the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, and director of the Nutrition Program at the Marcus Institute. "Current recommended strategies for maintenance of healthy bone mass are limited to consuming a diet rich in vitamins and minerals and performing weight bearing activity."

Osteoporotic fractures can have devastating health and economic consequences. Thirty percent of women will not survive the first year following a hip fracture, and in the United States 1.5 million fractures costs the healthcare system $17 billion annually. As our population ages and life expectancy increases, the burden of osteoporotic fractures will continue to rise without specific, safe, and effective ways to maintain bone mass with age."

Dr. Clifford J. Rosen, MD, Maine Medical Center Research Institute

"The proposed study is significant because it will test the efficacy of the synbiotic medical food, SBD111, to maintain bone density with age," said Dr. Eric Schott, co-founder and COO, Solarea Bio. "It also will provide the mechanistic insights leading to strategies for the dietary management of the metabolic processes underlying osteopenia and osteoporosis."

"Osteoporotic fractures result in more hospitalizations than heart attacks, strokes, and breast cancer combined and cause severe pain, long-term disability, and early death," said Douglas P. Kiel, MD., MPH, director of the Musculoskeletal Research Center at Hebrew SeniorLife's Hinda and Arthur Marcus Institute for Aging Research and professor of medicine at Harvard Medical School. "The projected increase in age-related osteoporotic fractures is estimated to be more than 48% between 2005 to 2025 with direct costs exceeding $25 billion in 2025."

Hebrew SeniorLife Hinda and Arthur Marcus Institute for Aging Research investigators are Dr. Shivani Sahni, PhD (PI), Dr. Douglas P. Kiel, MD MPH (Co-I), and Dr. Thomas G. Travison (Co-I). Solarea Bio collaborators are Dr. Eric Schott, PhD (PI), and Dr. Gerardo V. Toledo, PhD (Co-I). USDA HNRCA at Tufts University collaborator is Dr. Paul F. Jacques, DSc (PI). Maine Medical Center Research Institute (MMCRI) collaborator is Dr. Clifford J. Rosen, MD (PI).