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

July 31, 2020 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Brazilian National Institute of Hormones and Women's Health

Investigators

  • Study Director: Poli Mara Spritzer, MD PhD, Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

December 21, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 170019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe