Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

NCTNCT00421408Other id0610001951Other idR01AR053701Other id1R01AR053701-01A1

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names IGF-1 (mecasermin), does not test it. It appears in the conditions.

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 208 participants (actual)
Sponsor: Yale University · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Feb 2007
Primary completion: May 2012
Completion: Sept 2012
First posted: 12 Jan 2007 (estimated)
Last update posted: 9 Apr 2020
Conditions: Bone Resorption · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2007200820092010201120122013

Ph 1/2
The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women
NCT00421408
Feb 2007 to Sept 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Whey protein supplementDietary supplement
PlaceboDietary supplement

Arms2

Experimental
Protein powder
Participants will receive a protein supplement daily (40 g whey protein supplement).
Placebo comparator
Placebo carbohydrate
Participants will receive a placebo supplement daily (40 g maltodextrin).

Primary outcomes7

Outcomes the sponsor listed as primary.

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Measured at baseline and 18 months

Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline

Group	Value (percentage change)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	0.51	0.38
Protein Powder 40 g Daily for 18 Months	0.51	0.38

Primary outcomeMean· Measured at baseline and 18 months

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

Group	Value (percent change)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	-0.07	1.08
Protein Powder 40 g Daily for 18 Months	-2.64	1.81

Primary outcomeLeast squares mean· Measured at 0 months

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

Group	Value (g/cm^2)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	1.10	0.01
Protein Powder 40 g Daily for 18 Months	1.13	0.01

Primary outcomeLeast squares mean· Measured at 9 months

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

Group	Value (g/cm^2)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	1.14	0.02
Protein Powder 40 g Daily for 18 Months	1.12	0.01

Primary outcomeLeast squares mean· Measured at 18 months

Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months

Group	Value (g/cm^2)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	1.14	0.02
Protein Powder 40 g Daily for 18 Months	1.12	0.01

Primary outcomeLeast squares mean· Measured at 0 months

Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline

Group	Value (mg/cm^3)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	106	3.72
Protein Powder 40 g Daily for 18 Months	103	4.51

Primary outcomeLeast squares mean· Measured at 18 months

Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months

Group	Value (mg/cm^3)	Spread
Placebo Carbohydrate 40 g Daily for 18 Months	106	4.07
Protein Powder 40 g Daily for 18 Months	99.3	4.29

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo Carbohydrate Powder 40 g Daily	–	14 / 102	46 / 102
Protein Powder 40 g Daily	–	4 / 106	56 / 106

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedKerstetter 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

Eligibility

Who could join, as posted.

Sex: All
Age: from 60 Years up to 85 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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