NCT03024125

Brief Summary

This study evaluates the effect of different types of diets (high and normal protein) on lean and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8 protein g/body mass/day). The same training will be performed for both groups.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

October 31, 2016

Last Update Submit

January 17, 2017

Conditions

Sarcopenia

Keywords

lean masspostmenopausalprotein

Outcome Measures

Primary Outcomes (1)

  • Changes in the lean mass of postmenopausal women practicing strength exercise

    Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)

Secondary Outcomes (2)

  • Changes in the fat mass of postmenopausal women practicing strength exercise

    Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)

  • Changes on strength of postmenopausal women practicing strength exercise

    Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)

Study Arms (2)

High protein diet (HP)

EXPERIMENTAL

Diet with 1.2 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups

Other: High proteinOther: Training

Normal protein diet (NP)

PLACEBO COMPARATOR

Diet with 0.8 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups

Other: Normal proteinOther: Training

Interventions

High proteinOTHER

To observe the effect of a high protein (HP) diet over muscle mass, fat mass, and strength changes, focusing in differences between the NP and HP groups.

High protein diet (HP)
Normal proteinOTHER

To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes

Normal protein diet (NP)
TrainingOTHER

The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.

High protein diet (HP)Normal protein diet (NP)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
  • Healthy;
  • Who agree to participate and sign the consent term.

You may not qualify if:

  • The one who does not provide the necessary information for the development of the study;
  • Present orthopedic limitations;
  • Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Nahas PC, Rossato LT, Martins FM, Souza AP, de Branco FMS, Carneiro MAS, Teixeira KRC, Orsatti FL, de Oliveira EP. Moderate Increase in Protein Intake Promotes a Small Additional Improvement in Functional Capacity, But Not in Muscle Strength and Lean Mass Quality, in Postmenopausal Women Following Resistance Exercise: A Randomized Clinical Trial. Nutrients. 2019 Jun 13;11(6):1323. doi: 10.3390/nu11061323.

    PMID: 31200437DERIVED

  • Rossato LT, Nahas PC, de Branco FMS, Martins FM, Souza AP, Carneiro MAS, Orsatti FL, de Oliveira EP. Higher Protein Intake Does Not Improve Lean Mass Gain When Compared with RDA Recommendation in Postmenopausal Women Following Resistance Exercise Protocol: A Randomized Clinical Trial. Nutrients. 2017 Sep 12;9(9):1007. doi: 10.3390/nu9091007.

    PMID: 28895933DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Erick P de Oliveira, PhD

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 31, 2016

First Posted

January 18, 2017

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

February 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share