Completed

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

What is being tested

High Protein Diet

+ Control Diet

Other

Who is being recruted

Atrophy+5

+ Muscular Atrophy

+ Nervous System Diseases

Over 65 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional

Study Start: January 2017

See protocol details

Summary

Principal SponsorHospital de Clinicas de Porto Alegre

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 9, 2017

Actual date on which the first participant was enrolled.

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

NCT03652584

Principal SponsorHospital de Clinicas de Porto Alegre

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AtrophyMuscular AtrophyNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalNeuromuscular Manifestations

Criteria

2 inclusion criteria required to participate

Postmenopausal women

Without mobility aids, able to perform activities of daily living independently

5 exclusion criteria prevent from participating

Use of hormone therapy in the past 3 months

Insulin therapy

Previous diagnosis of heart disease

Untreated thyroid diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Low glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months

Group II

Active Comparator

Low glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers