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OpenTrials
Completed

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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Key information

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

High protein diet

Other

Control diet

Other

Primary outcomes

  1. Change in whole-body and appendicular lean mass

    Time frame: 6 months

    measured by dual-energy X-ray absorptiometry

Secondary outcomes

  1. Change in isometric hand grip strength

    Time frame: 6 months

    measured by dynamometry

  2. Change in usual gait speed

    Time frame: 6 months

    in a 4-m course

  3. Change in systolic blood pressure

    Time frame: 6 months

    in mmHg

  4. Change in diastolic blood pressure

    Time frame: 6 months

    in mmHg

  5. Change in fat mass

    Time frame: 6 months

    measured by dual-energy X-ray absorptiometry

  6. Change in resting metabolic rate

    Time frame: 6 months

    measured by indirect calorimetry

  7. Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides

    Time frame: 6 months

    determined by colorimetric-enzymatic methods

  8. Change in glucose

    Time frame: 6 months

    determined by the hexokinase method

  9. Change in insulin

    Time frame: 6 months

    measured by chemiluminescence immunoassays

  10. 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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