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

Not Applicable

Completed

• Conditions: Muscle Loss; Physical Disability
• Interventions: Other: High Protein Diet; Other: Control Diet

• Registration Number: NCT03652584
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Primary Completion: 2018-12-21
• Study Completion: 2019-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Protein Diet	High Protein Diet	Low glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months
Control Diet	Control Diet	Low glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months

Primary Outcome Measures

Name	Time	Method
Change in whole-body and appendicular lean mass	6 months	measured by dual-energy X-ray absorptiometry

Secondary Outcome Measures

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