NCT03785002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

1.4 years

First QC Date

October 27, 2018

Last Update Submit

May 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Maximal strength (kg)

    At the 14th week of study participation.

  • Isometric peak torque (PTiso) (N.m)

    At the 14th week of study participation.

  • Body fat free mass (g)

    At the 14th week of study participation

  • Body fat mass (g)

    At the14th week of study participation.

  • Protein intake (g)

    At the 14th week of study participation.

Study Arms (2)

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)

Other: Strength trainingOther: 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)

Other: Strength trainingOther: Protein intake

Interventions

24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week

non vegetarianvegetarian

Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)

non vegetarianvegetarian

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriela Luccciana Martini

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertrophy

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carolina G de Souza, PHD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2018

First Posted

December 24, 2018

Study Start

February 20, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations