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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03652584

Enrollment

Registered

2018-08-29

Start date

2017-01-09

Completion date

2019-12-31

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Loss, Physical Disability

Keywords

postmenopause, diet, Skeletal muscle mass

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.

Interventions

OTHERHigh Protein Diet

OTHERControl Diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in usual gait speed	6 months	in a 4-m course
Change in systolic blood pressure	6 months	in mmHg
Change in diastolic blood pressure	6 months	in mmHg
Change in fat mass	6 months	measured by dual-energy X-ray absorptiometry
Change in isometric hand grip strength	6 months	measured by dynamometry
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 insulin	6 months	measured by chemiluminescence immunoassays
Change in high-sensitivity C-reactive protein	6 months	measured by nephelometric method
Change in resting metabolic rate	6 months	measured by indirect calorimetry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026