NCT Number: NCT03652584
Effects of High Protein Diet on Muscle Mass, Strength, and Physical Performance in Postmenopausal Women
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.
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Notify MeKey information
Conditions
Age range
65 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Control diet
OtherPrimary outcomes
-
Change in whole-body and appendicular lean mass
Time frame: 6 months
measured by dual-energy X-ray absorptiometry
Secondary outcomes
-
Change in isometric hand grip strength
Time frame: 6 months
measured by dynamometry
-
Change in usual gait speed
Time frame: 6 months
in a 4-m course
-
Change in systolic blood pressure
Time frame: 6 months
in mmHg
-
Change in diastolic blood pressure
Time frame: 6 months
in mmHg
-
Change in fat mass
Time frame: 6 months
measured by dual-energy X-ray absorptiometry
-
Change in resting metabolic rate
Time frame: 6 months
measured by indirect calorimetry
-
Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides
Time frame: 6 months
determined by colorimetric-enzymatic methods
-
Change in glucose
Time frame: 6 months
determined by the hexokinase method
-
Change in insulin
Time frame: 6 months
measured by chemiluminescence immunoassays
-
Change in high-sensitivity C-reactive protein
Time frame: 6 months
measured by nephelometric method
Sponsors and collaborators
Lead sponsor
Hospital de Clinicas de Porto Alegre
Other
Collaborators
- Brazilian National Institute of Hormones and Women's Health
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
Registry information
Official study title
A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Aug 29, 2018
- Registry last updated
- Aug 4, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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