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Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians

Primary Purpose

Strength Training, Dietary Proteins, Muscle Strength

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strength training
Protein intake
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Strength Training

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gabriela Luccciana Martini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vegetarian

non vegetarian

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Muscle Thickness (mm)
To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants.

Secondary Outcome Measures

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.
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.
Body fat free mass (g)
To compare body fat free mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
Body fat mass (g)
To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
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.

Full Information

First Posted
October 27, 2018
Last Updated
May 21, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03785002
Brief Title
Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians
Official Title
Comparison of Strength and Muscle Thickness of Recreational Sports Individuals With Vegetarian or Non-vegetarian Food Standards Adequate in Proteins
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strength Training, Dietary Proteins, Muscle Strength, Hypertrophy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vegetarian
Arm Type
Experimental
Arm Description
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)
Arm Title
non vegetarian
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
Intervention Type
Other
Intervention Name(s)
Protein intake
Intervention Description
Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
Primary Outcome Measure Information:
Title
Muscle Thickness (mm)
Description
To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants.
Time Frame
At the14th week of study participation.
Secondary Outcome Measure Information:
Title
Maximal strength (kg)
Description
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.
Time Frame
At the 14th week of study participation.
Title
Isometric peak torque (PTiso) (N.m)
Description
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.
Time Frame
At the 14th week of study participation.
Title
Body fat free mass (g)
Description
To compare body fat free mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
Time Frame
At the 14th week of study participation
Title
Body fat mass (g)
Description
To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
Time Frame
At the14th week of study participation.
Title
Protein intake (g)
Description
To compare daily protein intake (g) assessed by 24 hour reminder, applied in interview conducted by nutritionist, of omnivorous and vegetarian participants.
Time Frame
At the 14th week of study participation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina G de Souza, PHD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gabriela Luccciana Martini
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians

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