SarcopeniaNCT03024125
High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains
A study testing High protein, Normal protein and Training in people with Sarcopenia, run by Federal University of Uberlandia.
Trial summary
This study evaluates the effect of different types of diets (high and normal protein) on lean and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8 protein g/body mass/day). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- High protein, Normal protein and Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Feb 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
- Healthy;
- Who agree to participate and sign the consent term.
Who cannot join
- The one who does not provide the necessary information for the development of the study;
- Present orthopedic limitations;
- Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
About this study
Official title: Effect of Normal and High Protein Diets in Lean Mass, Adiposity, and Strength in Postmenopausal Women Practitioners of Resistance Exercise
This study evaluates the effect of different types of diets (high and normal protein) on lean and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8 protein g/body mass/day). The same training will be performed for both groups.
Read the detailed description
Both groups will undergo the same training protocol, differing only on the protein content of the diet. The dietary assessment will be made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. SPPB, tug, 6-minutes and 400 meters will be performed.
- Conditions
- Sarcopenia
- Being tested
- High protein, Normal protein, Training
- Keywords
- lean mass, postmenopausal, protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High proteinOther
To observe the effect of a high protein (HP) diet over muscle mass, fat mass, and strength changes, focusing in differences between the NP and HP groups.
Normal proteinOther
To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes
TrainingOther
The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.
| Study group | Role | What they receive |
|---|---|---|
| High protein diet (HP) | Experimental | Diet with 1.2 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups Receives: Other: High protein; Other: Training |
| Normal protein diet (NP) | Placebo comparator | Diet with 0.8 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups Receives: Other: Normal protein; Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the lean mass of postmenopausal women practicing strength exercise
Measured: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Secondary outcomes (2)
Changes in the fat mass of postmenopausal women practicing strength exercise
Measured: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Changes on strength of postmenopausal women practicing strength exercise
Measured: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick Prado de Oliveira, Federal University of Uberlandia
- Investigators
- Erick P de Oliveira, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024125
- Sponsor's protocol ID
- 1.733.512
- Status last verified
- Jan 2017
- First submitted
- 31 Oct 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Nahas PC, Rossato LT, Martins FM, Souza AP, de Branco FMS, Carneiro MAS, Teixeira KRC, Orsatti FL, de Oliveira EP. Moderate Increase in Protein Intake Promotes a Small Additional Improvement in Functional Capacity, But Not in Muscle Strength and Lean Mass Quality, in Postmenopausal Women Following Resistance Exercise: A Randomized Clinical Trial. Nutrients. 2019 Jun 13;11(6):1323. doi: 10.3390/nu11061323.
PubMed 31200437Rossato LT, Nahas PC, de Branco FMS, Martins FM, Souza AP, Carneiro MAS, Orsatti FL, de Oliveira EP. Higher Protein Intake Does Not Improve Lean Mass Gain When Compared with RDA Recommendation in Postmenopausal Women Following Resistance Exercise Protocol: A Randomized Clinical Trial. Nutrients. 2017 Sep 12;9(9):1007. doi: 10.3390/nu9091007.
PubMed 28895933
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normal and High Protein Diets in Lean Mass, Adiposity, and Strength in Postmenopausal Women Practitioners of Resistance Exercise
- ClinicalTrials.gov ID
- NCT03024125
- Acronym / sponsor ID
- 1.733.512
- Conditions
- Sarcopenia
- Keywords
- lean mass, postmenopausal, protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
This study evaluates the effect of different types of diets (high and normal protein) on lean and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8 protein g/body mass/day). The same training will be performed for both groups.
Detailed description
Both groups will undergo the same training protocol, differing only on the protein content of the diet. The dietary assessment will be made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. SPPB, tug, 6-minutes and 400 meters will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein diet (HP) | Experimental | Other: High protein, Other: TrainingDiet with 1.2 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups |
| Normal protein diet (NP) | Placebo comparator | Other: Normal protein, Other: TrainingDiet with 0.8 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
- Healthy;
- Who agree to participate and sign the consent term.
Key exclusion criteria (3 listed)
- The one who does not provide the necessary information for the development of the study;
- Present orthopedic limitations;
- Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
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 proteinTo observe the effect of a high protein (HP) diet over muscle mass, fat mass, and strength changes, focusing in differences between the NP and HP groups. | Other | High protein diet (HP) |
| Normal proteinTo observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes | Other | Normal protein diet (NP) |
| TrainingThe physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy. | Other | High protein diet (HP), Normal protein diet (NP) |
Primary outcome
Changes in the lean mass of postmenopausal women practicing strength exercise
Time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
2 secondary outcomes
Changes in the fat mass of postmenopausal women practicing strength exercise
Time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Changes on strength of postmenopausal women practicing strength exercise
Time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 31200437Nahas PC, Rossato LT, Martins FM, Souza AP, de Branco FMS, Carneiro MAS, Teixeira KRC, Orsatti FL, de Oliveira EP. Moderate Increase in Protein Intake Promotes a Small Additional Improvement in Functional Capacity, But Not in Muscle Strength and Lean Mass Quality, in Postmenopausal Women Following Resistance Exercise: A Randomized Clinical Trial. Nutrients. 2019 Jun 13;11(6):1323. doi: 10.3390/nu11061323.
- Derived from this study: PubMed 28895933Rossato LT, Nahas PC, de Branco FMS, Martins FM, Souza AP, Carneiro MAS, Orsatti FL, de Oliveira EP. Higher Protein Intake Does Not Improve Lean Mass Gain When Compared with RDA Recommendation in Postmenopausal Women Following Resistance Exercise Protocol: A Randomized Clinical Trial. Nutrients. 2017 Sep 12;9(9):1007. doi: 10.3390/nu9091007.
- Individual participant dataSharing planned: No
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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.
Erick P de Oliveira, PhD principal investigator
Federal University of Uberlandia
Questions about this trial
What is this clinical trial studying?
A study testing High protein, Normal protein and Training in people with Sarcopenia, run by Federal University of Uberlandia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Changes in the lean mass of postmenopausal women practicing strength exercise (time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03024125, which also lists 2 linked publications.
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 18 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.