- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03785002
Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians
May 21, 2020 updated by: Hospital de Clinicas de Porto Alegre
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil
- Gabriela Luccciana Martini
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vegetarian
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)
|
24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
|
Active Comparator: non vegetarian
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)
|
24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the14th week of study participation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal strength (kg)
Time Frame: At the 14th week of study participation.
|
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.
|
At the 14th week of study participation.
|
Isometric peak torque (PTiso) (N.m)
Time Frame: At the 14th week of study participation.
|
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.
|
At the 14th week of study participation.
|
Body fat free mass (g)
Time Frame: At the 14th week of study participation
|
To compare body fat free mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
|
At the 14th week of study participation
|
Body fat mass (g)
Time Frame: At the14th week of study participation.
|
To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
|
At the14th week of study participation.
|
Protein intake (g)
Time Frame: At the 14th week of study participation.
|
To compare daily protein intake (g) assessed by 24 hour reminder, applied in interview conducted by nutritionist, of omnivorous and vegetarian participants.
|
At the 14th week of study participation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carolina G de Souza, PhD, Hospital de Clínicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2018
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
October 27, 2018
First Submitted That Met QC Criteria
December 19, 2018
First Posted (Actual)
December 24, 2018
Study Record Updates
Last Update Posted (Actual)
May 22, 2020
Last Update Submitted That Met QC Criteria
May 21, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69787617.0.0000.5327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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