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

NCT00421408 | Completed Phase 1 Results DMC

• 3 other identifiers: 0610001951R01AR0537011R01AR053701-01A1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Resorption; Osteoporosis

Keywords

Dietary protein; Calcium; Parathyroid hormone; Bone markers; Bone mineral density; IGF-1; Urine Calcium

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Protein powder

EXPERIMENTAL

Participants will receive a protein supplement daily (40 g whey protein supplement).

Dietary Supplement: Whey protein supplement

Placebo carbohydrate

PLACEBO COMPARATOR

Participants will receive a placebo supplement daily (40 g maltodextrin).

Dietary Supplement: Placebo

Interventions

Whey protein supplement DIETARY_SUPPLEMENT

40-g whey protein supplement daily for 18 months

Protein powder

Placebo DIETARY_SUPPLEMENT

Placebo supplement daily for 18 months

Placebo carbohydrate

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

• 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.

  PMID: 16730418 BACKGROUND

• 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.

  PMID: 17048062 BACKGROUND

• 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.

  PMID: 25844619 DERIVED

MeSH Terms

Conditions

Bone Resorption; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The limitations of this study include the large attrition rate due to the length of the intervention and the difficulty in adhering to 40 grams of protein or placebo powder as a daily supplement.

Results Point of Contact

• Title: Dr. Karl Insogna
• Organization: Yale University

Karl.insogna@yale.edu

203-737-2871

Study Officials

• Karl L. Insogna, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 12, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 9, 2020
• Results First Posted: August 28, 2013

Record last verified: 2020-03

Locations

US (2)