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

NCT03652584 | Completed

• 1 other identifier: 170019
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Loss; Physical Disability

Keywords

postmenopause; diet; Skeletal muscle mass

Outcome Measures

Primary Outcomes (1)

• Change in whole-body and appendicular lean mass

  measured by dual-energy X-ray absorptiometry

  6 months

Secondary Outcomes (10)

• Change in isometric hand grip strength

  6 months

• Change in usual gait speed

  6 months

• Change in systolic blood pressure

  6 months

• Change in diastolic blood pressure

  6 months

• Change in fat mass

  6 months

Study Arms (2)

High Protein Diet

EXPERIMENTAL

Low glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months

Other: High Protein Diet

Control Diet

ACTIVE COMPARATOR

Low glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months

Other: Control Diet

Interventions

High Protein Diet OTHER

High Protein Diet

Control Diet OTHER

Control Diet

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of hormone therapy in the past 3 months
• Insulin therapy
• Previous diagnosis of heart disease
• Untreated thyroid diseases
• Conditions affecting neuromuscular function

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Brazilian National Institute of Hormones and Women's Health: collaborator

MeSH Terms

Conditions

Muscular Atrophy

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Poli Mara Spritzer, MD PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 29, 2018
• Study Start: January 9, 2017
• Primary Completion: December 21, 2018
• Study Completion: December 1, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-07