NCT05576337

Brief Summary

A strict vegetarian diet includes only foods of plant-based origin and, despite being able to meet the nutritional needs of individuals of different ages, when correctly planned, it commonly offers a lower protein intake than a non-vegetarian diet. Daily protein intake directly influences the turnover of body proteins (synthesis vs. degradation rates), being important for the maintenance of skeletal muscle mass, tissue that performs metabolic functions in the body and enables the performance of tasks of daily living. In addition, the practice of strength training (ST) interferes in muscle mass increasing rates, also exerting an influence in muscle quality, strength and power increase, which are associated with better physical fitness, quality of life and health. To make these increases possible, especially in relation to morphological aspects, a higher protein intake than recommended for the general population is necessary (1.2 to 1.6 g/kg/day), which requires careful dietary planning, especially when the consumption of meat, eggs and dairy products, which are important sources of this nutrient, is excluded. Thus, the present study has two main objectives: to compare the neuromuscular characteristics of strict vegetarians (VE) and non-vegetarians (NV) (Phase 1 - cross-sectional) and the neuromuscular adaptations induced by 16 weeks of ST (Phase 2 - longitudinal).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

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

May 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.6 years

First QC Date

September 23, 2022

Last Update Submit

October 13, 2024

Conditions

Keywords

Muscle massMuscle qualityStrengthPower

Outcome Measures

Primary Outcomes (3)

  • Quadriceps femoris muscle thickness assessed by ultrasonography images

    Quadriceps femoris muscle thickness (vastus lateralis (VL) + rectus femoris (RF) + vastus medialis (VM) + vastus intermedius (VI) muscle thickness (MT, mm)) will be assessed by ultrasonography equipament. The RF and VI images will be assessed at two-thirds of the distance between the greater trochanter and the lateral epicondyle of the femur. VL images will be assessed at midpoint between greater trochanter and the lateal epicondyle of the femur. Thus, VM images will be assessed at the location corresponding to 30% of the distance between the lateral epicondyle and the greater trochanter of the femur. The images analisys will realized, posteriorly, by Image-J software.

    Change from baseline at 16 weeks of strength training

  • Hamstrings muscle thickness assessed by ultrasonography images

    Hamstrings muscle thickness (i.e femural bíceps and semitendinosus muscle thickness; MT (mm)) will be assessed by ultrasonography images. Thi images will be obteined at 50% of distance between femur´s greater trochanter and the lateral line of the knee joint. In the image obtained, the muscle tissue between the adipose tissue interfaces will be identified, and the distance between these tissues will be defined as the muscle thickness. The analysis of the images will be carried out in the Image-J software.

    Change from baseline at 16 weeks of strength training

  • Gastrocnemius muscle thickness assessed by ultrasonography images

    Will be asssesed by images obteined by ultrasonography equipament. The points for capturing the ultrasonography images of the gastrocnemius will be marked with a dermographic pen in the most medial cross-sectional area and with the greatest volume, verified with the probe. In the image obtained, the muscle tissue between the adipose tissue interfaces will be identified, and the distance between these tissues will be defined as the muscle thickness. The analysis of the images will be carried out in the Image-J software.

    Change from baseline at 16 weeks of strength training

Secondary Outcomes (17)

  • Lower limb muscle power in the jumping performance test assessed by a contact mat

    Change from baseline at 16 weeks of strength training

  • Rigth thigh dynamic muscle strength assessed by isokinetic dynamometer

    Change from baseline at 16 weeks of strength training

  • Knee extensors dynamic muscle strength assessed by one maximum repetition test

    Change from baseline at 16 weeks of strength training

  • Knee flexors dynamic muscle strength assessed by one maximum repetition test

    Change from baseline at 16 weeks of strength training

  • Plantar flexors dynamic muscle strength assessed by one maximum repetition test

    Change from baseline at 16 weeks of strength training

  • +12 more secondary outcomes

Study Arms (2)

Strict vegetarians

EXPERIMENTAL

Strict vegetarians women

Other: 16 weeks of strength training protocol

non vegetarians

EXPERIMENTAL

Non vegetarians women

Other: 16 weeks of strength training protocol

Interventions

16 weeks of strength training protocol

Strict vegetariansnon vegetarians

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index until 30kg/m²
  • Be a strict vegetarian or non-vegetarian for at least 6 months
  • Not performing regular physical exercise for at least 6 months

You may not qualify if:

  • Having chronic diseases, such as systemic arterial hypertension, diabetes mellitus, cardiomyopathy
  • Present physical limitations or musculoskeletal problems, which contraindicate the performance of strength exercises
  • Make use of a protein or amino acid food supplement, caffeine or other thermogenic substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul (UFRGS)

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ronei Silveira Pinto

    Federal University of Rio Grande do Sul (UFRGS)

    PRINCIPAL INVESTIGATOR
  • Claúdia Dornelles Schneider

    Federal University of Healthy Sciences of Porto Alegre (UFCSPA)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Teacher/Doctor

Study Record Dates

First Submitted

September 23, 2022

First Posted

October 12, 2022

Study Start

May 1, 2022

Primary Completion

December 13, 2023

Study Completion

October 13, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations