Neuromuscular Characteristics of Strict Vegetarians and Non-Vegetarians Women

NCT ID: NCT05576337

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-10-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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). For Phase 1, 140 healthy adults of both sexes (70 VE and 70 NV) will be recruited, who have been strength-untrained and who have adhered to the respective dietary pattern, both for at least 6 months. Participants will be instructed to perform the 3-day food record and count the number of steps for 5 days. Subsequently, they will undergo assessments of body composition, physical activity level and neuromuscular tests of the lower limbs (maximum strength, jumping power and muscle thickness of the quadriceps femoris, hamstring and gastrocnemius muscles). Comparisons of means between groups will be performed by the T test - independent. Results will be expressed as mean and standard deviation and the accepted significance level will be 5%. For Phase 2, 33 VE and 33 NV will be recruited (66 participants in total), who, in addition to meeting the eligibility criteria set out in Phase 1, are also available to participate in the strength training period. Participants will undergo the same assessments provided for in Phase 1 and must maintain their respective eating habits and patterns. At the 4th, 8th, 12th, and 16th weeks of ST, all participants will complete a new 3-day food record and perform step counts. In the 17th week, the initial evaluations will be repeated. Comparisons will be performed through two-way analysis of variance with repeated measures, considering the factors group (2 stratifications), time (2 stratifications) and group x time interaction. Results will be expressed as mean and standard deviation and the accepted significance level will be 5%.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Strict vegetarians

Strict vegetarians women

Group Type EXPERIMENTAL

16 weeks of strength training protocol

Intervention Type OTHER

16 weeks of strength training protocol

non vegetarians

Non vegetarians women

Group Type EXPERIMENTAL

16 weeks of strength training protocol

Intervention Type OTHER

16 weeks of strength training protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

16 weeks of strength training protocol

16 weeks of strength training protocol

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ronei Silveira Pinto

University Teacher/Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronei Silveira Pinto

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul (UFRGS)

Claúdia Dornelles Schneider

Role: STUDY_DIRECTOR

Federal University of Healthy Sciences of Porto Alegre (UFCSPA)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Rio Grande do Sul (UFRGS)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

52472821.6.0000.5347

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.