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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Karl Insogna, Yale University
ClinicalTrials.gov Identifier:
NCT00421408
First received: January 11, 2007
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Bone Resorption
Osteoporosis
 Dietary Supplement: Whey protein supplement
Dietary Supplement: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of a Protein Supplement on Bone Mass in Older Men and Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in anterior-posterior spine bone mass density measured by dual energy X-ray absorptiometry (DEXA) compared to baseline [ Time Frame: Measured at 0, 9, and 18 months ] [ Designated as safety issue: No ]
  • Change in spine and hip BMD measured by quantitative computed tomography (QCT) compared to baseline [ Time Frame: Measured at 0 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum parathyroid hormone compared to baseline [ Time Frame: Measured at 0, 9, and 18 months ] [ Designated as safety issue: No ]
  • Change in serum bone turnover markers compared to baseline [ Time Frame: Measured at 0, 9, and 18 months ] [ Designated as safety issue: No ]
  • Change in serum Insulin like growth factor 1 (IGF-1) and binding protein 3 (IGFBP-3) compared to baseline [ Time Frame: Measured at 0, 9, and 18 months ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: February 2007
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein powder
Participants will receive a protein supplement daily (40 g whey protein supplement).
 Dietary Supplement: Whey protein supplement
40-g whey protein supplement daily for 18 months
Placebo Comparator: Placebo carbohydrate
Participants will receive a placebo supplement daily (40 g maltodextrin).
 Dietary Supplement: Placebo
Placebo supplement daily for 18 months

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

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421408

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Karl L. Insogna, MD Yale University
  More Information

Publications:

Responsible Party: Karl Insogna, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT00421408     History of Changes
Other Study ID Numbers: R01 AR053701, R01AR053701, 1R01AR053701-01A1
Study First Received: January 11, 2007
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Dietary protein
Calcium
Parathyroid hormone
Bone markers
 Bone mineral density
IGF-1
Urine Calcium

Additional relevant MeSH terms:
Bone Resorption
Osteoporosis
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Metabolic

ClinicalTrials.gov processed this record on June 18, 2013