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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652584
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : October 7, 2019
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Brazilian National Institute of Hormones and Women's Health
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief 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.

Condition or disease Intervention/treatment Phase
Muscle Loss Physical Disability Other: High Protein Diet Other: Control Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : December 21, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: High Protein Diet
Low glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months
Other: High Protein Diet
Active Comparator: Control Diet
Low glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months
Other: Control Diet



Primary Outcome Measures :
  1. Change in whole-body and appendicular lean mass [ Time Frame: 6 months ]
    measured by dual-energy X-ray absorptiometry


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652584


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Brazilian National Institute of Hormones and Women's Health
Investigators
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Study Director: Poli Mara Spritzer, MD PhD Federal University of Rio Grande do Sul

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03652584    
Other Study ID Numbers: 170019
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
postmenopause
diet
Skeletal muscle mass