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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03024125
Other study ID # 1.733.512
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 31, 2016
Last updated January 17, 2017
Start date May 2016
Est. completion date February 2017

Study information

Verified date January 2017
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date February 2017
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Normal protein
To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes
Training
The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
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