The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Office of Dietary Supplements (ODS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00421408

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Impact of a Protein Supplement on Bone Mass in Older Men and Women

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Osteoporosis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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 IGF-1 and IGFBP-3 compared to baseline [ Time Frame: Measured at 0, 9, and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2007
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive a protein supplement daily.	Dietary Supplement: Whey protein supplement 40-g whey protein supplement daily for 18 months
2: Placebo Comparator Participants will receive a placebo supplement daily.	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
Yale University	Recruiting
New Haven, Connecticut, United States, 06520
Contact: Rebecca R. Sullivan, MS, RD 203-737-1656 Becky.sullivan@yale.edu
Principal Investigator: Karl L Insogna, MD
University of Connecticut Health Center	Recruiting
Farmington, Connecticut, United States, 06030
Contact: Jennifer Brindisi, MA 860-679-7581 brindisi@nso1.uchc.edu
Principal Investigator: Anne Kenny, MD

Sponsors and Collaborators

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:

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. Epub 2006 May 26.

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. 2006 Oct 18; [Epub ahead of print]

Responsible Party:	Yale University ( Karl L. Insogna, MD )
Study ID Numbers:	R01 AR053701, 1R01AR053701-01A1
Study First Received:	January 11, 2007
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00421408 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Dietary protein
Calcium
Parathyroid hormone
Bone markers

Bone mineral density
IGF-1
Urine Calcium

Study placed in the following topic categories:

Calcium, Dietary
Whey Protein
Musculoskeletal Diseases
Bone Resorption
Osteoporosis

Bone Diseases, Metabolic
Healthy
Hormones
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Bone Resorption
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on September 09, 2009