Effect of Protein-nutrition Beverages on Muscle Protein Synthesis in Women

Study Overview
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Brief Summary
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This study investigates whether a protein-nutrition beverage can increase muscle protein synthesis to a similar magnitude as a control beverage.

Detailed Description
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Potential participants will be screened, and if eligible, invited to participate. Body composition and physical activity level will be assessed during the initiation visit. During the trial visits, women receive a protein-nutrition beverage; muscle protein synthesis is assessed via blood analytes and muscle biopsies at rest and after exercise. Statistical analysis includes mixed model regression approach with change in muscle protein synthesis as the primary outcome.

Official Title
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A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal Muscle Protein Synthesis in Women

Conditions
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Muscle Protein Synthesis

Intervention / Treatment
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* Other: Protein-nutrition beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older women, 65 to 75 years of age At least 5 years post-menopausal Body mass index (BMI) 20.00-29.99 kg/m2 Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial Low to moderate habitual physical activity ( > 3500 but < 10,000 steps/d, no structured activity) In general good health (stage I hypertension allowed - 140/90) on the basis of medical history; and taking no medication other than anti-hypertensives, selective serotonin-reuptake inhibitors, and/or statins (excluding simvastatin [Zocor] and atorvastatin [Lipitor]) Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. Participant can consume a protein drink in the allotted time frame of 10 minutes Exclusion Criteria: History or presence of clinically important renal or gastrointestinal disorders, diabetes mellitus (glucose >126 mg/dL, fingerstick) or metabolic disease, unstable arrhythmia, angina, taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications. Vegan Smoker Overt osteoporosis and/or osteopenia and/or sarcopenia as determined by DXA High physical activity or participating in regular structured exercise (> 10,000 steps/d) History of allergy, sensitivity, or strong dislike towards any of the components of the study products (dairy protein) Use of an investigational drug product within the last 30 days Having participated in an another infusion protocol in the past year Individual has a condition the PI believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk Subject does not understand English

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Protein-nutrition beverage - Placebo<br>: 8 oz protein-nutrition beverage 1 | Other: Protein-nutrition beverage<br>* Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter<br>|
| Experimental: Protein-nutrition beverage - Beverage 2<br>8 oz protein-nutrition beverage 2 | Other: Protein-nutrition beverage<br>* Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter<br>|
| Experimental: Protein-nutrition beverage - Beverage 3<br>8 oz protein-nutrition beverage 3 | Other: Protein-nutrition beverage<br>* Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter<br>|
| Experimental: Protein-nutrition beverage - Beverage 4<br>8 oz protein-nutrition beverage 4 | Other: Protein-nutrition beverage<br>* Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (timei -baseline) of muscle protein synthesis at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage |  | 0-3 hours post consumption and 5 days post consumptions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (timei -baseline) of blood sample analytes at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage |  | 0-3 hours post consumption and 5 days post consumptions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle protein synthesis