NCT06423209

Brief Summary

The study consisted of a non-randomized controlled clinical trial with measurements at baseline and at the end of a 16 week intervention. Participants will be assigned to the intervention or control group according to their own choice and convenience. A 4 arm split was performed where the Veg-Int group was composed of people on a vegan diet who participated in the intervention, the Veg-Con group was composed of people on a vegan diet who were part of the control group, the Omn-Int group was composed of people on an omnivorous diet who participated in the intervention, and the Omn-Con group was composed of people on an omnivorous diet who were part of the control group. The Veg-Int and Omn-Int intervention groups, participated in a physical exercise program in remote modality through a digital mHealth platform. During the 16 weeks of intervention, a total of 50 training sessions were carried out, distributed in three sessions per week, with a duration per session ranging from 40 to 50 minutes. The exercise program was designed and supervised by a physical education teacher and focused on strength training using body weight exercises targeting the major muscle groups, including upper body, lower body and abdominals. The platform recorded participants attendance and the time they spent on each exercise session. At the end of the sessions, participants had the option to evaluate and share their perception of effort during the workout through a Modified Borg scale (0-10). In addition, they were given the opportunity to communicate with the teacher via phone call, text message or e-mail, to receive feedback or raise doubts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 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

February 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 15, 2024

Last Update Submit

May 20, 2024

Conditions

Keywords

vegan dietomnivorous dietstrength training

Outcome Measures

Primary Outcomes (7)

  • Body weight

    Differential between kg of body weight before and after the development of the intervention

    16 weeks of intervention

  • waist circumference

    Differential between centimeters of waist circumference before and after the development of the intervention

    16 weeks of intervention

  • fat mass

    Differential of the percentage of fat mass before and after the intervention

    16 weeks of intervention

  • Lean mass

    Differential of kilograms of lean mass before and after the intervention

    16 weeks of intervention

  • maximum strength

    Differential of kilograms of maximum strength by biceps curl exercise

    16 weeks of intervention

  • Manual grip strength

    Differential of manual grip strength of both hands using a hydraulic dynamometer.

    16 weeks of intervention

  • Vertical jump

    Differential evaluation of muscle power by means of a vertical jump

    16 weeks of intervention

Study Arms (4)

Vegan Intervention

EXPERIMENTAL

The intervention group is composed of people who follow a vegan diet and who will be part of an intervention program for 16 weeks, consisting of a physical exercise program of strength resistance with 3 sessions per week. Each session will be guided by a physical activity professional and will last from 45 to 50 minutes.

Other: Strength training program

omnivorous intervention

EXPERIMENTAL

The intervention group is composed of people who follow a omnivorous diet and who will be part of an intervention program for 16 weeks, consisting of a physical exercise program of strength resistance with 3 sessions per week. Each session will be guided by a physical activity professional and will last from 45 to 50 minutes.

Other: Strength training program

vegan control

NO INTERVENTION

People who follow an vegan diet who were part of the control group. They were evaluated before and after the intervention.

omnivorous control

NO INTERVENTION

People who follow an omnivorous diet who were part of the control group. They were evaluated before and after the intervention.

Interventions

Strength training program to be developed during 16 weeks. There will be 3 exercise sessions per week and those participants who perform at least 2 sessions during the program will be considered for the statistical analysis.

Vegan Interventionomnivorous intervention

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richar Carcamo Regla

Concepción, Concepcion, 4030000, Chile

Location

Related Publications (6)

  • Boutros GH, Landry-Duval MA, Garzon M, Karelis AD. Is a vegan diet detrimental to endurance and muscle strength? Eur J Clin Nutr. 2020 Nov;74(11):1550-1555. doi: 10.1038/s41430-020-0639-y. Epub 2020 Apr 24.

    PMID: 32332862BACKGROUND
  • Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18.

    PMID: 33599941BACKGROUND
  • Reid-McCann RJ, Brennan SF, McKinley MC, McEvoy CT. The effect of animal versus plant protein on muscle mass, muscle strength, physical performance and sarcopenia in adults: protocol for a systematic review. Syst Rev. 2022 Apr 13;11(1):64. doi: 10.1186/s13643-022-01951-2.

    PMID: 35418173BACKGROUND
  • van de Brekel JA, Duurkens VA, Vanderschueren RG. Pneumothorax. Results of thoracoscopy and pleurodesis with talc poudrage and thoracotomy. Chest. 1993 Feb;103(2):345-7. doi: 10.1378/chest.103.2.345.

    PMID: 8432116BACKGROUND
  • Hannaian SJ, Churchward-Venne TA. Meatless Muscle Growth: Building Muscle Size and Strength on a Mycoprotein-Rich Vegan Diet. J Nutr. 2023 Jun;153(6):1665-1667. doi: 10.1016/j.tjnut.2023.04.011. Epub 2023 Apr 14. No abstract available.

    PMID: 37062484BACKGROUND
  • Pohl A, Schunemann F, Bersiner K, Gehlert S. The Impact of Vegan and Vegetarian Diets on Physical Performance and Molecular Signaling in Skeletal Muscle. Nutrients. 2021 Oct 29;13(11):3884. doi: 10.3390/nu13113884.

    PMID: 34836139BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rafael E Zapata Lamana, Doctor

    Universidad de Concepcion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study consisted of a 4-arm non-randomized controlled clinical trial, with measurements at the beginning and end of a 16-week intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

February 2, 2022

Primary Completion

May 2, 2022

Study Completion

October 30, 2022

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Has not been considered or discussed yet

Locations