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High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains

Primary Purpose

Sarcopenia

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

High protein

Normal protein

Training

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring lean mass, postmenopausal, protein

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High protein diet (HP)

Normal protein diet (NP)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in the lean mass of postmenopausal women practicing strength exercise

Secondary Outcome Measures

Changes in the fat mass of postmenopausal women practicing strength exercise

Changes on strength of postmenopausal women practicing strength exercise

Full Information

NCT ID

NCT03024125

First Posted

October 31, 2016

Last Updated

January 17, 2017

Sponsor

Federal University of Uberlandia

1. Study Identification

Unique Protocol Identification Number

NCT03024125

Brief Title

High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains

Official Title

Effect of Normal and High Protein Diets in Lean Mass, Adiposity, and Strength in Postmenopausal Women Practitioners of Resistance Exercise

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Uberlandia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Both groups will undergo the same training protocol, differing only on the protein content of the diet. The dietary assessment will be made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. SPPB, tug, 6-minutes and 400 meters will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcopenia

Keywords

lean mass, postmenopausal, protein

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High protein diet (HP)

Arm Type

Experimental

Arm Description

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

Arm Title

Normal protein diet (NP)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

High protein

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Normal protein

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Training

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in the lean mass of postmenopausal women practicing strength exercise

Time Frame

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

Secondary Outcome Measure Information:

Title

Changes in the fat mass of postmenopausal women practicing strength exercise

Time Frame

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

Title

Changes on strength of postmenopausal women practicing strength exercise

Time Frame

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

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erick P de Oliveira, PhD

Organizational Affiliation

Federal University of Uberlandia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31200437

Citation

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.

Results Reference

derived

PubMed Identifier

28895933

Citation

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.

Results Reference

derived

Learn more about this trial

High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains

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