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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diet and Muscle Function In Older Adults

NCT02069314

Sarcopenia

COMPLETED NA

Utilizing Protein During Weight Loss to Impact Physical Function and Bone

NCT03819478

Obesity Weight Loss Diet Modification +6 more

COMPLETED NA

Effect of Intake of Whey Protein in Elderly Osteopenic Patients. Implications for Metabolism and Physical Function.

NCT01900548

Osteopenia

COMPLETED NA

Effect of Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly

NCT01640145

Skeletal Muscle Protein Synthesis in Elderly Protein Kinetics Sarcopenia

COMPLETED NA

Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

NCT01057680

Osteoporosis Sarcopenia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Resorption Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Protein powder

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

Group Type EXPERIMENTAL

Whey protein supplement

Intervention Type DIETARY_SUPPLEMENT

40-g whey protein supplement daily for 18 months

Placebo carbohydrate

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement daily for 18 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey protein supplement

40-g whey protein supplement daily for 18 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo supplement daily for 18 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes