Optimizing Protein Intake in Older Americans With Mobilit... | NCT01275365

NCT01275365

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
7R01AG037547	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute on Aging (NIA)	NIH

Description Module

Detailed Description

The recommended dietary allowance (RDA) for protein, set at 0.8 grams/kg/day for adult men and women, has engendered debate and many experts advocate protein intakes substantially above the RDA to help maintain muscle anabolism in older individuals. It is not known whether increasing protein intake in older Americans, whose current intake is below the RDA, increases skeletal muscle mass, muscle performance and physical function.

Our first aim is to determine whether administration of 1.3 g/kg/day of protein, compared to the RDA (0.8 g/kg/day), will result in greater improvements in lean body mass, maximal voluntary muscle strength and power, and self-reported and performance-based measures of physical function in older men. Our second aim is to determine whether the gains in lean body mass, maximal voluntary strength and self-reported and performance-based measures of physical function during testosterone administration are greater with 1.3 g protein than with the RDA in older men on a eucaloric diet.

We will conduct a randomized, placebo-controlled, double-blind trial using a 2 X 2 factorial design. Community dwelling men, 65 years or older, who have self-reported mobility limitation, a daily protein intake of <0.8 g/kg/day and no contraindications for testosterone therapy, will be randomly assigned to one of four groups: placebo injections plus protein 0.8 g/kg/day; placebo injections plus protein 1.3 g/kg/day; testosterone enanthate 100 mg weekly plus protein 0.8 g/kg/day; testosterone enanthate 100 mg weekly plus protein 1.3 g/kg/day. Treatment duration will be 6 months. The primary outcome is change in lean body mass from baseline to 6 months, measured by dual energy X-ray absorptiometry. Secondary outcomes include change in maximal voluntary strength in leg and chest press exercises, leg power, self-reported (physical function domain of SF-36) and performance-based measures of physical function (6-min walking distance and speed, stair climbing power, and load carrying), fatigue, well-being and affectivity balance. Safety measures include urinary calcium excretion, hematocrit, prostate specific antigen (PSA) and prostate examination.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo/Low Protein	No Intervention	Placebo injections weekly; 0.8 g/kg/day protein
Placebo/High Protein	No Intervention	Placebo injections weekly; 1.3 g/kg/day protein
Testosterone/Low Protein	Other	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein	Drug: Testosterone enanthate
Testosterone/High Protein	Other	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein	Drug: Testosterone enanthate

Name	Type	Description	Arm Group Labels	Other Names
Testosterone enanthate	Drug	Testosterone enanthate 100 mg intramuscularly weekly	Testosterone/Low Protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)	Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)	6 months from baseline

Secondary Outcomes

Measure	Description	Time Frame
Change of Maximal Voluntary Strength	Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.	6 months from baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Community-dwelling men 65 years of age or older
A score of 3-10 on the short physical performance battery (SPPB)
Daily protein intake less than the recommended daily allowance of 0.83 g/kg/day (from 3 24-hour food recalls)
Able to give informed consent

Exclusion Criteria:

History of prostate or breast cancer
American Urological Association [AUA] symptom index score of >19
Prostate specific antigen (PSA) >4 ng/ml in White men or >3 ng/ml in Black men
Prostate specific antigen (PSA) > 4 ng/ml in non-Black men or >3 ng/ml in Black men. These subjects may be enrolled if they have a negative transrectal biopsy within the past year.
Myocardial infarction or stroke within the last 6 months
Uncontrolled congestive heart failure, based on the study physician's evaluation
Serum creatinine > 2.0 mg/dL; men on any kind of dialysis will be excluded.
History of celiac disease, Crohn's disease, or ulcerative colitis
History of any malignancy requiring treatment within the previous 2 years, except non-melanic skin cancers. Men with cancers who have not required active treatment within the past two years and who have not had disease recurrence within the past two years may be enrolled at the discretion of the study physician.
Neuromuscular diseases: motor neuron diseases, multiple sclerosis, adult muscular dystrophies, and myasthenia gravis
History of stroke with residual limb weakness that affected the individual's ability to walk; subjects with history of stroke who do not have residual limb weakness may be enrolled.
Schizophrenia, bipolar disorder, or untreated diagnosed depression. Subjects with unipolar depression who are on an antidepressant medication are eligible.
TSH levels <0.4 or >5 mlU/L
Systolic blood pressure (BP) >160 or diastolic BP >100 mm Hg (average of 2 measurements taken at Visit 1)
Hemoglobin A1c >8.0% or taking insulin. Men with diabetes mellitus whose A1C is less than 8.0% or who are not taking insulin will be eligible.
Mini-Mental Status Exam [MMSE] <24
Body mass index (BMI) less than 20 or greater than 40 kg/m2
Not willing to eat all of the following: red meat, eggs, poultry, fish and shellfish
Allergy to sesame, peanuts, soy, gluten or shellfish
Current alcohol use >21 drinks/week based on self-report
Confinement to a wheelchair
Use of anabolic therapies (Testosterone, DHEA, androstenedione, rhGH) within the past year
Current use of levodopa or anticoagulants
Current enrollment in a structured weight management program or participation in any weight intervention studies in the last 90 days
Serum ALT and AST greater than 3 x upper limit of normal
Hematocrit < 30% or >48%
Subject is not able to eat 3 frozen study meals per day for 6 months
Subject is unwilling to stop current nutritional supplements
Progressive intensive resistance training within 12 weeks of screening
Non-compliant with run-in diet and/or supplement

Name	Affiliation	Role
Shalender Bhasin, MD	Brigham and Women's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33417663	Derived	Huang G, Pencina K, Li Z, Apovian CM, Travison TG, Storer TW, Gagliano-Juca T, Basaria S, Bhasin S. Effect of Protein Intake on Visceral Abdominal Fat and Metabolic Biomarkers in Older Men With Functional Limitations: Results From a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2021 May 22;76(6):1084-1089. doi: 10.1093/gerona/glab007.
30932132	Derived	Krok-Schoen JL, Archdeacon Price A, Luo M, Kelly OJ, Taylor CA. Low Dietary Protein Intakes and Associated Dietary Patterns and Functional Limitations in an Aging Population: A NHANES analysis. J Nutr Health Aging. 2019;23(4):338-347. doi: 10.1007/s12603-019-1174-1.

Arm/Group Information

ID	Title	Description
FG000	Placebo/Low Protein	Placebo injections weekly; 0.8 g/kg/day protein
FG001	Placebo/High Protein	Placebo injections weekly; 1.3 g/kg/day protein
FG002	Testosterone/Low Protein	Testosterone enanthate 100 mg intramuscularly weekly; 0.8 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly
FG003	Testosterone/High Protein	Testosterone enanthate 100 mg intramuscularly weekly; 1.3 g/kg/day protein Testosterone enanthate: Testosterone enanthate 100 mg intramuscularly weekly

Baseline Characteristics Module

ID	Title	Description
BG000	Placebo/Low Protein	Placebo injections weekly; 0.8 g/kg/day protein
BG001	Placebo/High Protein	Placebo injections weekly; 1.3 g/kg/day protein

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)

Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)

All randomized and treated participants with data available at the given time-point.

Posted

Mean

Standard Error

6 months from baseline

ID	Title	Description
OG000	Placebo/Low Protein	Placebo injections weekly; 0.8 g/kg/day protein
OG001	Placebo/High Protein	Placebo injections weekly; 1.3 g/kg/day protein
OG002

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo/Low Protein	Placebo injections weekly; 0.8 g/kg/day protein	0

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms