Clinical trial NCT03024125: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: lean mass
postmenopausal
protein
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the lean mass of postmenopausal women practicing strength exercise
timeFrame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Secondary outcomes:
measure: Changes in the fat mass of postmenopausal women practicing strength exercise
timeFrame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
measure: Changes on strength of postmenopausal women practicing strength exercise
timeFrame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Uberlandia
name: Erick P de Oliveira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.