Effects of High Protein Diet on Muscle Mass, Strength, and Physical Performance in Postmenopausal Women

Study Overview
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Brief Summary
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Despite the importance of preventing muscle mass loss during senescence, only a few studies have investigated the relationship between diet and muscle mass in postmenopausal women. Therefore, the aim of this study is to investigate whether controlled protein consumption at the current Recommended Daily Allowance (RDA = 0.8 g/kg body weight) or twice the RDA (1.6 g/kg body weight) affects skeletal muscle mass, strength, and physical performance in postmenopausal women. In this parallel-group trial, participants were randomized for 6 months to low glycemic index diets with controlled protein consumption at the current RDA or twice the RDA, aimed to balance energy needs.

Official Title
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A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women

Conditions
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Muscle Loss, Physical Disability

Intervention / Treatment
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* Other: High Protein Diet
* Other: Control Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women Without mobility aids, able to perform activities of daily living independently Exclusion Criteria: Use of hormone therapy in the past 3 months Insulin therapy Previous diagnosis of heart disease Untreated thyroid diseases Conditions affecting neuromuscular function

Ages Eligible for Study
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Minimum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Protein Diet<br>Low glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months | Other: High Protein Diet<br> <br> |
| Active Comparator: Control Diet<br>Low glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months | Other: Control Diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in whole-body and appendicular lean mass | measured by dual-energy X-ray absorptiometry | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in isometric hand grip strength | measured by dynamometry | 6 months | 
| Change in usual gait speed | in a 4-m course | 6 months | 
| Change in systolic blood pressure | in mmHg | 6 months | 
| Change in diastolic blood pressure | in mmHg | 6 months | 
| Change in fat mass | measured by dual-energy X-ray absorptiometry | 6 months | 
| Change in resting metabolic rate | measured by indirect calorimetry | 6 months | 
| Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides | determined by colorimetric-enzymatic methods | 6 months | 
| Change in glucose | determined by the hexokinase method | 6 months | 
| Change in insulin | measured by chemiluminescence immunoassays | 6 months | 
| Change in high-sensitivity C-reactive protein | measured by nephelometric method | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, postmenopause, Skeletal muscle mass