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OUR PREVIOUS RESEARCH IN ANIMALS AND POSTMENOPAUSAL WOMEN INDICATE THAT DRIED PLUM IS EFFICACIOUS IN PREVENTING AND REVERSING BONE LOSS AND IMPROVING BIOMARKERS OF BONE METABOLISM AND INFLAMMATION. WE PROPOSE A RANDOMIZED CONTROLLED CLINICAL TRIAL TO TEST THE HYPOTHESIS THAT DAILY CONSUMPTION OF DRIED PLUM FOR ONE YEAR DOSE-DEPENDENTLY PREVENTS INFLAMMATION AND SUBSEQUENTLY THE LOSS OF BONE IN MEN WITH A LUMBAR SPINE BONE MINERAL DENSITY (BMD) T-SCORE BETWEEN 1 AND 2 SD BELOW THE MEAN. MEN (N = 200) WILL BE RANDOMLY ASSIGNED TO THEIR TREATMENT GROUP: 50 G DRIED PLUM, 100 G DRIED PLUM, OR CONTROL FOR ONE YEAR. IN ORDER TO PROVIDE SOME PROTECTION AGAINST FURTHER BONE LOSS, ALL STUDY PARTICIPANTS WILL RECEIVE 500 MG ELEMENTAL CALCIUM AND 400 IU VITAMIN D3 DAILY. BMD AND BONE MINERAL CONTENT (BMC) OF THE LUMBAR SPINE, FOREARM, HIP AND WHOLE BODY WILL BE ASSESSED AT BASELINE, 6- AND 12-MONTH VISITS USING DUAL-ENERGY X-RAY ABSORPTIOMETRY. BLOOD AND URINE SAMPLES WILL BE ASSESSED FOR: 1) SYSTEMIC AND EX VIVO INFLAMMATION AND OSTEOCLASTOGENESIS TO DETERMINE WHETHER INCREASED ANTI-INFLAMMATORY DEFENSE IS, IN PART, RESPONSIBLE FOR DRIED PLUM'S BONE-PROTECTIVE EFFECTS AND 2) SERUM AND URINARY MARKERS OF BONE METABOLISM. ADDITIONALLY, BLOOD LEVELS OF 25-HYDROXY VITAMIN D WILL BE ASSESSED AS AN INDICATOR OF DIETARY VITAMIN D3 INTAKE. ALSO, BLOOD AND URINARY METABOLITES OF DRIED PLUM POLYPHENOLS WILL BE ANALYZED IN ORDER TO INVESTIGATE THE RELATIONSHIP BETWEEN CHANGES IN THESE METABOLITES AND IMPROVEMENTS IN OUTCOME MEASURES. 30% ATTRITION WILL YIELD A FINAL SAMPLE SIZE OF 140 WITH A POWER ADEQUATE FOR DETECTING CHANGES IN MEAN BMD OF 2% IN THE GROUP RECIEVEING 100 G DRIED PLUM. PRIMARY OUTCOME VARIABLES WILL BE PERCENT CHANGE IN BMD AND BMC OF THE LUMBAR SPINE. THIS STUDY WILL PROVIDE CRITICAL DATA ABOUT AN ACCEPTABLE AND EFFICACIOUS FUNCTIONAL FOOD TO PREVENT INFLAMMATION AND IMPROVE BONE HEALTH IN OSTEOPENIC MEN.

$468,385FY2017National Institute of Food and AgricultureUSDA

Florida State University, Tallahassee FL

Investigators

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OUR PREVIOUS RESEARCH IN ANIMALS AND POSTMENOPAUSAL WOMEN INDICATE THAT DRIED PLUM IS EFFICACIOUS IN PREVENTING AND REVERSING BONE LOSS AND IMPROVING BIOMARKERS OF BONE METABOLISM AND INFLAMMATION. WE PROPOSE A RANDOMIZED CONTROLLED CLINICAL TRIAL TO TEST THE HYPOTHESIS THAT DAILY CONSUMPTION OF DRIED PLUM FOR ONE YEAR DOSE-DEPENDENTLY PREVENTS INFLAMMATION AND SUBSEQUENTLY THE LOSS OF BONE IN MEN WITH A LUMBAR SPINE BONE MINERAL DENSITY (BMD) T-SCORE BETWEEN 1 AND 2 SD BELOW THE MEAN. MEN (N = 200) WILL BE RANDOMLY ASSIGNED TO THEIR TREATMENT GROUP: 50 G DRIED PLUM, 100 G DRIED PLUM, OR CONTROL FOR ONE YEAR. IN ORDER TO PROVIDE SOME PROTECTION AGAINST FURTHER BONE LOSS, ALL STUDY PARTICIPANTS WILL RECEIVE 500 MG ELEMENTAL CALCIUM AND 400 IU VITAMIN D3 DAILY. BMD AND BONE MINERAL CONTENT (BMC) OF THE LUMBAR SPINE, FOREARM, HIP AND WHOLE BODY WILL BE ASSESSED AT BASELINE, 6- AND 12-MONTH VISITS USING DUAL-ENERGY X-RAY ABSORPTIOMETRY. BLOOD AND URINE SAMPLES WILL BE ASSESSED FOR: 1) SYSTEMIC AND EX VIVO INFLAMMATION AND OSTEOCLASTOGENESIS TO DETERMINE WHETHER INCREASED ANTI-INFLAMMATORY DEFENSE IS, IN PART, RESPONSIBLE FOR DRIED PLUM'S BONE-PROTECTIVE EFFECTS AND 2) SERUM AND URINARY MARKERS OF BONE METABOLISM. ADDITIONALLY, BLOOD LEVELS OF 25-HYDROXY VITAMIN D WILL BE ASSESSED AS AN INDICATOR OF DIETARY VITAMIN D3 INTAKE. ALSO, BLOOD AND URINARY METABOLITES OF DRIED PLUM POLYPHENOLS WILL BE ANALYZED IN ORDER TO INVESTIGATE THE RELATIONSHIP BETWEEN CHANGES IN THESE METABOLITES AND IMPROVEMENTS IN OUTCOME MEASURES. 30% ATTRITION WILL YIELD A FINAL SAMPLE SIZE OF 140 WITH A POWER ADEQUATE FOR DETECTING CHANGES IN MEAN BMD OF 2% IN THE GROUP RECIEVEING 100 G DRIED PLUM. PRIMARY OUTCOME VARIABLES WILL BE PERCENT CHANGE IN BMD AND BMC OF THE LUMBAR SPINE. THIS STUDY WILL PROVIDE CRITICAL DATA ABOUT AN ACCEPTABLE AND EFFICACIOUS FUNCTIONAL FOOD TO PREVENT INFLAMMATION AND IMPROVE BONE HEALTH IN OSTEOPENIC MEN. · GrantIndex