Effects of High Protein Diet on Muscle Mass, Strength, an... | NCT03652584

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

NCT03652584

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Completed

Last Update Posted

Aug 4, 2020Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Muscle Loss
Physical Disability

Interventions

High Protein Diet
Control Diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2017Actual

Primary Completion Date

Dec 21, 2018Actual

Completion Date

Dec 2019Actual

First Submitted Date

Aug 17, 2018

First Submission Date that Met QC Criteria

Aug 28, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2020

Last Update Posted Date

Aug 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Hospital de Clinicas de Porto AlegreOTHER

Collaborators

Name	Class
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV
Brazilian National Institute of Hormones and Women's Health	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
High Protein Diet	Other		High Protein Diet
Control Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in whole-body and appendicular lean mass	measured by dual-energy X-ray absorptiometry	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in isometric hand grip strength	measured by dynamometry	6 months
Change in usual gait speed	in a 4-m course	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poli Mara Spritzer, MD PhD	Federal University of Rio Grande do Sul	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009133	Muscular Atrophy

Ancestor Terms

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001284	Atrophy

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073600	Diet, High-Protein

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided