Effects of High Protein Diet on Muscle Mass, Strength, and Physical Performance in Postmenopausal Women

Physical Disability Clinical Trial

Official title:

A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652584
• Other study ID #: 170019
• Status: Completed
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the importance of preventing muscle mass loss during senescence, only a few studies have investigated the relationship between diet and muscle mass in postmenopausal women. Therefore, the aim of this study is to investigate whether controlled protein consumption at the current Recommended Daily Allowance (RDA = 0.8 g/kg body weight) or twice the RDA (1.6 g/kg body weight) affects skeletal muscle mass, strength, and physical performance in postmenopausal women. In this parallel-group trial, participants were randomized for 6 months to low glycemic index diets with controlled protein consumption at the current RDA or twice the RDA, aimed to balance energy needs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2019
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women

• Without mobility aids, able to perform activities of daily living independently

Exclusion Criteria:

• Use of hormone therapy in the past 3 months

• Insulin therapy

• Previous diagnosis of heart disease

• Untreated thyroid diseases

• Conditions affecting neuromuscular function

Related Conditions & MeSH terms

• Muscle Loss
• Physical Disability

Intervention

Other:
• High Protein Diet

• Control Diet

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Brazilian National Institute of Hormones and Women's Health, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in whole-body and appendicular lean mass	measured by dual-energy X-ray absorptiometry	6 months
Secondary	Change in isometric hand grip strength	measured by dynamometry	6 months
Secondary	Change in usual gait speed	in a 4-m course	6 months
Secondary	Change in systolic blood pressure	in mmHg	6 months
Secondary	Change in diastolic blood pressure	in mmHg	6 months
Secondary	Change in fat mass	measured by dual-energy X-ray absorptiometry	6 months
Secondary	Change in resting metabolic rate	measured by indirect calorimetry	6 months
Secondary	Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides	determined by colorimetric-enzymatic methods	6 months
Secondary	Change in glucose	determined by the hexokinase method	6 months
Secondary	Change in insulin	measured by chemiluminescence immunoassays	6 months
Secondary	Change in high-sensitivity C-reactive protein	measured by nephelometric method	6 months