The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of a Protein Supplement on Bone Mass in Older Men and Women

Conditions
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Bone Resorption, Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Whey protein supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to travel to one of the study sites Women age 60 years or greater, men age 70 years or greater Dietary protein intake level between 0.6 g/kg and 1.0 g/kg at baseline Exclusion Criteria: Active Paget's disease Primary hyperparathyroidism or unexplained hypercalcemia Untreated hyperthyroidism or hyperthyroidism that has resulted from medical treatment Diabetes mellitus type 1 Cancer diagnosis for solid malignancies (e.g., cancer of the colon, breast,prostate, lungs, lymphocytes) within the 18 months prior to study entry Long-term use of chemotherapeutic drugs, aromatase inhibitors, or tamoxifen Active treatment for leukemia or multiple myeloma Active inflammatory bowel disease Life expectancy of less than 2 years Current and ongoing use of methotrexate, phenytoin, phenobarbital, or inhaled corticosteroids at a dose of greater than 800 mcg/day Use of raloxifene, estrogen, androgen, progesterone, soy isoflavones, oral glucocorticoids, or herbal supplements with estrogenic activity OR a change in dosage of thyroid medications within the 1 year prior to study entry if unwilling to avoid such agents during the duration of the study Current use of antiresorptive agents (e.g., calcitonin or bisphosphonates). More information about this criterion can be found in the protocol. serum creatinine greater than 1.2 mg/dl History of chronic liver disease or evidence of liver disease at screening Bilateral hip replacement women who have a bone mineral density T-score < -2.5 at either the hip or spine unless they have decided to decline treatment with conventional anti-osteoporotic medications Body mass index (BMI) greater than 32 or less than 19 Use of proton-pump inhibitors taken twice daily Fasting glucose level greater than 110 mg/dl Serum albumin level less than 3.0 mg/dl Kidney stones or history of kidney stones within the 3 years prior to study entry

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein powder<br>Participants will receive a protein supplement daily (40 g whey protein supplement). | Dietary Supplement: Whey protein supplement<br>* 40-g whey protein supplement daily for 18 months<br>|
| Placebo Comparator: Placebo carbohydrate<br>Participants will receive a placebo supplement daily (40 g maltodextrin). | Dietary Supplement: Placebo<br>* Placebo supplement daily for 18 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline | There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass. | Measured at baseline and 18 months | 
| Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline | There is no normative data for quantitative computed tomography it is based on local experience. | Measured at baseline and 18 months | 
| Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline | There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass. | Measured at 0 months | 
| Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months | There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass. | Measured at 9 months | 
| Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months | There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass. | Measured at 18 months | 
| Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline | There is no normative data for quantitative computed tomography it is based on local experience. | Measured at 0 months | 
| Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months | There is no normative data for quantitative computed tomography it is based on local experience. | Measured at 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary protein, Calcium, Parathyroid hormone, Bone markers, Bone mineral density, IGF-1, Urine Calcium