Clinical trial NCT00421408: The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women
Official title: Impact of a Protein Supplement on Bone Mass in Older Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bone Resorption
Osteoporosis
Keywords: Dietary protein
Calcium
Parathyroid hormone
Bone markers
Bone mineral density
IGF-1
Urine Calcium
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Office of Dietary Supplements (ODS)
First posted: 2007-01-12
Enrollment: 208
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline
timeFrame: Measured at baseline and 18 months
measure: Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline
timeFrame: Measured at baseline and 18 months
measure: Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline
timeFrame: Measured at 0 months
measure: Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months
timeFrame: Measured at 9 months
measure: Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months
timeFrame: Measured at 18 months
measure: Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline
timeFrame: Measured at 0 months
measure: Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months
timeFrame: Measured at 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Karl L. Insogna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newton KM, LaCroix AZ, Levy L, Li SS, Qu P, Potter JD, Lampe JW. Soy protein and bone mineral density in older men and women: a randomized trial. Maturitas. 2006 Oct 20;55(3):270-7. doi: 10.1016/j.maturitas.2006.04.011. Epub 2006 May 26.
citation: Uenishi K, Ishida H, Toba Y, Aoe S, Itabashi A, Takada Y. Milk basic protein increases bone mineral density and improves bone metabolism in healthy young women. Osteoporos Int. 2007 Mar;18(3):385-90. doi: 10.1007/s00198-006-0228-5. Epub 2006 Oct 18.
citation: Kerstetter JE, Bihuniak JD, Brindisi J, Sullivan RR, Mangano KM, Larocque S, Kotler BM, Simpson CA, Cusano AM, Gaffney-Stomberg E, Kleppinger A, Reynolds J, Dziura J, Kenny AM, Insogna KL. The Effect of a Whey Protein Supplement on Bone Mass in Older Caucasian Adults. J Clin Endocrinol Metab. 2015 Jun;100(6):2214-22. doi: 10.1210/jc.2014-3792. Epub 2015 Apr 6.