Muscle LossNCT03652584
Effects of High Protein Diet on Muscle Mass, Strength, and Physical Performance in Postmenopausal Women
A study testing High Protein Diet in people with Muscle Loss and Physical Disability, run by Hospital de Clinicas de Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss, Physical Disability
- What is being tested?
- High Protein Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Postmenopausal women
- Without mobility aids, able to perform activities of daily living independently
Who cannot join
- Use of hormone therapy in the past 3 months
- Insulin therapy
- Previous diagnosis of heart disease
- Untreated thyroid diseases
- Conditions affecting neuromuscular function
About this study
Official title: A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, 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.
- Conditions
- Muscle Loss, Physical Disability
- Being tested
- High Protein Diet, Control Diet
- Keywords
- postmenopause, diet, Skeletal muscle mass
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein DietOther
Control DietOther
| Study group | Role | What they receive |
|---|---|---|
| High Protein Diet | Experimental | Low glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months Receives: Other: High Protein Diet |
| Control Diet | Active comparator | Low glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months Receives: Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole-body and appendicular lean mass
measured by dual-energy X-ray absorptiometry
Measured: 6 months
Secondary outcomes (10)
Change in isometric hand grip strength
measured by dynamometry
Measured: 6 months
Change in usual gait speed
in a 4-m course
Measured: 6 months
Change in systolic blood pressure
in mmHg
Measured: 6 months
Change in diastolic blood pressure
in mmHg
Measured: 6 months
Change in fat mass
measured by dual-energy X-ray absorptiometry
Measured: 6 months
Change in resting metabolic rate
measured by indirect calorimetry
Measured: 6 months
Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides
determined by colorimetric-enzymatic methods
Measured: 6 months
Change in glucose
determined by the hexokinase method
Measured: 6 months
Change in insulin
measured by chemiluminescence immunoassays
Measured: 6 months
Change in high-sensitivity C-reactive protein
measured by nephelometric method
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start9 Jan 2017
- Primary completion21 Dec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brazilian National Institute of Hormones and Women's Health
- Responsible party
- Sponsor
- Investigators
- Poli Mara Spritzer, MD PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652584
- Sponsor's protocol ID
- 170019
- Status last verified
- Jul 2020
- First submitted
- 17 Aug 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Intervention Study Investigating the Effects of High Protein Diet on Body Composition, Strength, and Physical Performance in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03652584
- Acronym / sponsor ID
- 170019
- Conditions
- Muscle Loss, Physical Disability
- Keywords
- postmenopause, diet, Skeletal muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Brazilian National Institute of Hormones and Women's Health
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein Diet | Experimental | Other: High Protein DietLow glycemic index dietary plan with 1.6 g/kg/day of protein for 6 months |
| Control Diet | Active comparator | Other: Control DietLow glycemic index dietary plan with 0.8 g/kg/day of protein for 6 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women
- Without mobility aids, able to perform activities of daily living independently
Key exclusion criteria (5 listed)
- Use of hormone therapy in the past 3 months
- Insulin therapy
- Previous diagnosis of heart disease
- Untreated thyroid diseases
- Conditions affecting neuromuscular function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Protein Diet | Other | High Protein Diet |
| Control Diet | Other | Control Diet |
Primary outcome
Change in whole-body and appendicular lean mass
Time frame: 6 months
measured by dual-energy X-ray absorptiometry
10 secondary outcomes
Change in isometric hand grip strength
Time frame: 6 months
Change in usual gait speed
Time frame: 6 months
Change in systolic blood pressure
Time frame: 6 months
Change in diastolic blood pressure
Time frame: 6 months
Change in fat mass
Time frame: 6 months
Change in resting metabolic rate
Time frame: 6 months
Change in total cholesterol, high-density lipoprotein cholesterol, and triglycerides
Time frame: 6 months
Change in glucose
Time frame: 6 months
Change in insulin
Time frame: 6 months
Change in high-sensitivity C-reactive protein
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poli Mara Spritzer, MD PhD study director
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet in people with Muscle Loss and Physical Disability, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in whole-body and appendicular lean mass (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.