Strength TrainingNCT03785002
Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians
A study testing Strength training and Protein intake in people with Strength Training and Dietary Proteins, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
A strength training session promotes increased muscle sensitivity to protein synthesis, which lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to the training session of approximately 20g or 0.24g / kg of high-quality protein in the same meal induces a plateau in this… Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Strength Training, Dietary Proteins, Muscle Strength
- What is being tested?
- Strength training and Protein intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Feb 2018to 30 Jun 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be over the age of 19 and under 60;
- Have BMI <30 kg / m²;
- Be vegetarian or omnivorous for at least 6 months;
- Have not exercised regularly for at least 6 months.
- Be available to practice bodybuilding at School of Physical Education, Physiotherapy and Dance, 2x / week, for 3 months, free (times to combine).
Who cannot join
- Be vegan, vegetarian lacto or vegetarian egg
- Be a carrier of chronic diseases;
- Present physical limitations or musculoskeletal problems, which contraindicate the performance of strength exercises;
- Failure to adhere to the proposed dietary modifications, relating to the adequacy of the portion of protein per meal, due to financial unfeasibility (low income condition);
- Use of protein or amino acid, caffeine or other thermogenic food supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Strength and Muscle Thickness of Recreational Sports Individuals With Vegetarian or Non-vegetarian Food Standards Adequate in Proteins
A strength training session promotes increased muscle sensitivity to protein synthesis, which lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to the training session of approximately 20g or 0.24g / kg of high-quality protein in the same meal induces a plateau in this synthesis. Thus, this study aims to compare the muscular strength between vegetarian and omnivorous athletes with adequate protein intake to reach this plateau. It will recruit 64 university sportsmen who have maintained vegetarian or omnivorous diet for at least 6 months, totalizing 32 individuals per group. After signing the Term of Consent, participants will be submitted to anthropometric and body composition assessment (via DEXA), neuromuscular tests [(ie, muscle strength - 1RM, peak torque of knee extensors (JE), muscle thickness of JE and cohort analysis (ANCOVA) will be used in order to compare the results of the study, and to compare the results of the covariance analysis (ANCOVA). the levels of the neuromuscular parameters between the groups, considering the initial values of the force and the initial muscular thickness as covariables, the other parameters will be presented in the form of mean and standard deviation or median, the differences will be considered significant for values of p <0, 05. Expected to find no differences in strength and muscle thickness between vegetarians and omnivores after adequate protein intake.
- Conditions
- Strength Training, Dietary Proteins, Muscle Strength, Hypertrophy
- Being tested
- Strength training, Protein intake
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
Protein intakeOther
Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
| Study group | Role | What they receive |
|---|---|---|
| vegetarian | Experimental | Individuals who do not consume meat (vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner) Receives: Other: Strength training; Other: Protein intake |
| non vegetarian | Active comparator | Individuals who do consume meat (non vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner) Receives: Other: Strength training; Other: Protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Thickness (mm)
To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants.
Measured: At the14th week of study participation.
Secondary outcomes (5)
Maximal strength (kg)
To compare maximal strength (kg), using the one- repetition maximum test (1RM) for bilateral knee extension exercises. Each subject's maximal load was determined with no more than five attempts and an adequate amount of recovery time was permitted between each attempt (3-5min). Each valid repetition was considered when subjects performed full knee extension with proper technique.
Measured: At the 14th week of study participation.
Isometric peak torque (PTiso) (N.m)
To compare knee extensors Isometric peak torque (N.m), defined as the highest value of the torque recorded during unilateral knee extension, using an isokinetic dynamometer, among vegetarian and omnivorous participants.
Measured: At the 14th week of study participation.
Body fat free mass (g)
To compare body fat free mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
Measured: At the 14th week of study participation
Body fat mass (g)
To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
Measured: At the14th week of study participation.
Protein intake (g)
To compare daily protein intake (g) assessed by 24 hour reminder, applied in interview conducted by nutritionist, of omnivorous and vegetarian participants.
Measured: At the 14th week of study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start20 Feb 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Strength TrainingStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina G de Souza, PHD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785002
- Sponsor's protocol ID
- 69787617.0.0000.5327
- Status last verified
- May 2020
- First submitted
- 27 Oct 2018
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martini GL, Pinto RS, Brusco CM, Franceschetto BF, Oliveira ML, Neske R, Cadore FL, Teodoro JL, Wilhelm EN, de Souza CG. Similar body composition, muscle size, and strength adaptations to resistance training in lacto-ovo-vegetarians and non-vegetarians. Appl Physiol Nutr Metab. 2023 Jun 1;48(6):469-478. doi: 10.1139/apnm-2022-0258. Epub 2023 Mar 1.
PubMed 36857740
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Strength and Muscle Thickness of Recreational Sports Individuals With Vegetarian or Non-vegetarian Food Standards Adequate in Proteins
- ClinicalTrials.gov ID
- NCT03785002
- Acronym / sponsor ID
- 69787617.0.0000.5327
- Conditions
- Strength Training, Dietary Proteins, Muscle Strength, Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 24 Dec 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.
A strength training session promotes increased muscle sensitivity to protein synthesis, which lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to the training session of approximately 20g or 0.24g / kg of high-quality protein in the same meal induces a plateau in this synthesis. Thus, this study aims to compare the muscular strength between vegetarian and omnivorous athletes with adequate protein intake to reach this plateau. It will recruit 64 university sportsmen who have maintained vegetarian or omnivorous diet for at least 6 months, totalizing 32 individuals per group. After signing the Term of Consent, participants will be submitted to anthropometric and body composition assessment (via DEXA), neuromuscular tests [(ie, muscle strength - 1RM, peak torque of knee extensors (JE), muscle thickness of JE and cohort analysis (ANCOVA) will be used in order to compare the results of the study, and to compare the results of the covariance analysis (ANCOVA). the levels of the neuromuscular parameters between the groups, considering the initial values of the force and the initial muscular thickness as covariables, the other parameters will be presented in the form of mean and standard deviation or median, the differences will be considered significant for values of p <0, 05. Expected to find no differences in strength and muscle thickness between vegetarians and omnivores after adequate protein intake.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vegetarian | Experimental | Other: Strength training, Other: Protein intakeIndividuals who do not consume meat (vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner) |
| non vegetarian | Active comparator | Other: Strength training, Other: Protein intakeIndividuals who do consume meat (non vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be over the age of 19 and under 60;
- Have BMI <30 kg / m²;
- Be vegetarian or omnivorous for at least 6 months;
- Have not exercised regularly for at least 6 months.
- Be available to practice bodybuilding at School of Physical Education, Physiotherapy and Dance, 2x / week, for 3 months, free (times to combine).
Key exclusion criteria (5 listed)
- Be vegan, vegetarian lacto or vegetarian egg
- Be a carrier of chronic diseases;
- Present physical limitations or musculoskeletal problems, which contraindicate the performance of strength exercises;
- Failure to adhere to the proposed dietary modifications, relating to the adequacy of the portion of protein per meal, due to financial unfeasibility (low income condition);
- Use of protein or amino acid, caffeine or other thermogenic food supplements.
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 |
|---|---|---|
| Strength training24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week | Other | non vegetarian, vegetarian |
| Protein intakeGuidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner) | Other | non vegetarian, vegetarian |
Primary outcome
Muscle Thickness (mm)
Time frame: At the14th week of study participation.
To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants.
5 secondary outcomes
Maximal strength (kg)
Time frame: At the 14th week of study participation.
Isometric peak torque (PTiso) (N.m)
Time frame: At the 14th week of study participation.
Body fat free mass (g)
Time frame: At the 14th week of study participation
Body fat mass (g)
Time frame: At the14th week of study participation.
Protein intake (g)
Time frame: At the 14th week of study participation.
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 22 May 2020.
- Derived from this study: PubMed 36857740Martini GL, Pinto RS, Brusco CM, Franceschetto BF, Oliveira ML, Neske R, Cadore FL, Teodoro JL, Wilhelm EN, de Souza CG. Similar body composition, muscle size, and strength adaptations to resistance training in lacto-ovo-vegetarians and non-vegetarians. Appl Physiol Nutr Metab. 2023 Jun 1;48(6):469-478. doi: 10.1139/apnm-2022-0258. Epub 2023 Mar 1.
- 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.
Carolina G de Souza, PHD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and Protein intake in people with Strength Training and Dietary Proteins, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 5 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Muscle Thickness (mm) (time frame: At the14th week of study participation.). 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 NCT03785002, which also lists 1 linked publication.
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 22 May 2020.