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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia
• Intervention / Treatment: Other: High protein; Other: Training; Other: Normal protein

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High protein diet (HP); 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 protein; 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.; Other: Training; The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.
Placebo Comparator: Normal protein diet (NP); 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: Training; The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.; Other: Normal protein; To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Erick P de Oliveira, PhD, Federal University of Uberlândia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: lean mass; postmenopausal; protein
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 1.733.512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No