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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03785002
Other study ID # 69787617.0.0000.5327
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2018
Est. completion date June 30, 2019

Study information

Verified date May 2020
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 60 Years
Eligibility 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 Design


Intervention

Other:
Strength training
24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
Protein intake
Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)

Locations

Country Name City State
Brazil Gabriela Luccciana Martini Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Thickness (mm) To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants. At the14th week of study participation.
Secondary 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. At the 14th week of study participation.
Secondary 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. At the 14th week of study participation.
Secondary Body fat free mass (g) 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
Secondary Body fat mass (g) To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants. At the14th week of study participation.
Secondary 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. At the 14th week of study participation.
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