Osteoporosis Clinical Trial
Official title:
Impact of a Protein Supplement on Bone Mass in Older Men and Women
Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this study is to determine whether a daily protein supplement will improve bone health among healthy older adults.
Dietary protein plays an important role in maintaining balanced calcium levels in the body.
Protein's impact on skeletal health remains unclear. It is well accepted that increasing
dietary protein results in greater excretion of calcium through urine. The excreted calcium
is thought to come in part from bone, which would suggest a negative effect on bone health.
However, recent studies have found that higher protein intake is, in fact, associated with
higher bone mineral density and lower rates of bone loss. The purpose of this study is to
determine if a daily protein supplement will improve bone health and hormonal measures of
bone metabolism among healthy older men and women who consume low-to-normal levels of dietary
protein.
This study will last 18 months. For the duration of the study, participants will be randomly
assigned to receive either a 40-gram protein supplement or placebo daily. There will be a
total of nine study visits that will occur at screening, study entry, Month 1.5, and every
three months thereafter. Dietary records, nutritional counseling, glucose finger stick tests,
and questionnaires related to falls, physical activity, habits, and study satisfaction will
occur at all study visits. Blood and urine collection, functional testing, and bone mineral
density (BMD) testing will occur at selected visits. At Months 0 and 18, half of the
participants will undergo a quantitative computed tomography (CT) scan to determine bone
mineral density.
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