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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:
Information provided by (Responsible Party):
Karl Insogna, Yale University
ClinicalTrials.gov Identifier:
NCT00421408
First received: January 11, 2007
Last updated: August 26, 2013
Last verified: August 2013
  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:


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 (DXA) Compared to Baseline [ Time Frame: Measured at baseline and 18 months ] [ Designated as safety issue: No ]
    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.

  • Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline [ Time Frame: Measured at baseline and 18 months ] [ Designated as safety issue: No ]
    There is no normative data for quantitative computed tomography it is based on local experience.

  • Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline [ Time Frame: Measured at 0 months ] [ Designated as safety issue: No ]
    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.

  • Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months [ Time Frame: Measured at 9 months ] [ Designated as safety issue: No ]
    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.

  • Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months [ Time Frame: Measured at 18 months ] [ Designated as safety issue: No ]
    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.

  • Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline [ Time Frame: Measured at 0 months ] [ Designated as safety issue: No ]
    There is no normative data for quantitative computed tomography it is based on local experience.

  • Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months [ Time Frame: Measured at 18 months ] [ Designated as safety issue: No ]
    There is no normative data for quantitative computed tomography it is based on local experience.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Results First Received: April 30, 2013
Last Updated: August 26, 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
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014