Bone ResorptionPhase 1/2NCT00421408

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

A Phase 1/2 study testing Whey protein supplement in people with Bone Resorption and Osteoporosis, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Bone Resorption, Osteoporosis
What is being tested?: Whey protein supplement
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 208 participants
Where: 2 sitesUnited States
Study dates: Feb 2007to Sep 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 21Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Connecticut Health Center
Farmington, Connecticut, 06030
Yale University
New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Impact of a Protein Supplement on Bone Mass in Older Men and Women

Read the 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.

Conditions: Bone Resorption, Osteoporosis
Being tested: Whey protein supplement, Placebo
Keywords: Dietary protein, Calcium, Parathyroid hormone, Bone markers, Bone mineral density, IGF-1, Urine Calcium
Medical subject headings: Bone Resorption, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whey protein supplementDietary supplement
40-g whey protein supplement daily for 18 months
PlaceboDietary supplement
Placebo supplement daily for 18 months

Study groups in NCT00421408
Study group	Role	What they receive
Protein powder	Experimental	Participants will receive a protein supplement daily (40 g whey protein supplement). Receives: Dietary Supplement: Whey protein supplement
Placebo carbohydrate	Placebo comparator	Participants will receive a placebo supplement daily (40 g maltodextrin). Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: 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: 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: 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: 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: 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: Measured at 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Sep 2012

First posted12 Jan 2007 (estimated)
Study startFeb 2007
Primary completionMay 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Bone ResorptionStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00421408
Sponsor's protocol ID: 0610001951
Other IDs: R01AR053701, 1R01AR053701-01A1
Status last verified: Mar 2020
First submitted: 11 Jan 2007
Last updated: 9 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1016/j.maturitas.2006.04.011. Epub 2006 May 26.
PubMed 16730418
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.
PubMed 17048062
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.
PubMed 25844619

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bone Resorption trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Protein Supplement on Bone Mass in Older Men and Women
ClinicalTrials.gov ID: NCT00421408
Acronym / sponsor ID: 0610001951
Conditions: Bone Resorption, Osteoporosis
Keywords: Dietary protein, Calcium, Parathyroid hormone, Bone markers, Bone mineral density, IGF-1, Urine Calcium
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Dietary Supplements (ODS)
Study start: Feb 2007
Primary completion: May 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 12 Jan 2007 (estimated)
Results: Posted 28 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Protein powder	Experimental	Dietary Supplement: Whey protein supplementParticipants will receive a protein supplement daily (40 g whey protein supplement).
Placebo carbohydrate	Placebo comparator	Dietary Supplement: PlaceboParticipants will receive a placebo supplement daily (40 g maltodextrin).

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whey protein supplement40-g whey protein supplement daily for 18 months	Dietary supplement	Protein powder
PlaceboPlacebo supplement daily for 18 months	Dietary supplement	Placebo carbohydrate

Primary outcome

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
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
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
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
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
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
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
There is no normative data for quantitative computed tomography it is based on local experience.

Results and safety

Results posted to the registry on 28 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Carbohydrate 40 g Daily for 18 Months	102	60
Protein Powder 40 g Daily for 18 Months	106	61

Primary outcome: 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. Mean (Standard Error). Unit: percentage change

Measure	Placebo Carbohydrate 40 g Daily for 18 Months n = 79	Protein Powder 40 g Daily for 18 Months n = 92
Value	0.51 (0.38)	0.51 (0.38)

Population analysed: Only participants with data at the baseline and 18 month timeframe were used in the analysis.

Primary outcome: Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline

Time frame: Measured at baseline and 18 months. Mean (Standard Error). Unit: percent change

Measure	Placebo Carbohydrate 40 g Daily for 18 Months n = 30	Protein Powder 40 g Daily for 18 Months n = 30
Value	-0.07 (1.08)	-2.64 (1.81)

Population analysed: Only participants with data at the baseline and 18 month timeframe were used in the analysis. Only half of the study partipants were randomized to receive Quantitative Computed Tomography testing.

Primary outcome: Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline

Time frame: Measured at 0 months. Least squares mean (Standard Error). Unit: g/cm^2

Measure	Placebo Carbohydrate 40 g Daily for 18 Months n = 102	Protein Powder 40 g Daily for 18 Months n = 106
Value	1.10 (0.01)	1.13 (0.01)

Population analysed: All participants were analyzed using the mixed models method.

Primary outcome: Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months

Time frame: Measured at 9 months. Least squares mean (Standard Error). Unit: g/cm^2

Measure	Placebo Carbohydrate 40 g Daily for 18 Months n = 102	Protein Powder 40 g Daily for 18 Months n = 106
Value	1.14 (0.02)	1.12 (0.01)

Population analysed: All participants were analyzed using the mixed models method.

Adverse events

Time frame: AE data was collected from July 2007 to May 2012. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Carbohydrate Powder 40 g Daily	14 of 102 (13.7%)	46 of 102 (45.1%)	Not reported
Protein Powder 40 g Daily	4 of 106 (3.8%)	56 of 106 (52.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16730418Newton 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.
Background: PubMed 17048062Uenishi 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.
Derived from this study: PubMed 25844619Kerstetter 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.

Related trials for Bone Resorption

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Active, not recruiting
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karl L. Insogna, MD principal investigator

Yale University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Whey protein supplement in people with Bone Resorption and Osteoporosis, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00421408, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.