Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet

NCT ID: NCT06423209

Last Updated: 2024-05-21

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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All participants were evaluated in weeks 0 and 17, immediately after the intervention program, under the same conditions in terms of protocol, calibrated instruments and the same evaluator.

The evaluation of nutritional status was carried out using the body mass index (BMI, Kg/m2), while the waist circumference was measured by passing a measuring tape at the height of the navel, midpoint between the costal margin and the crest. iliac, at the end of a normal expiration and recorded in centimeters.

Body composition analysis was obtained by the bioimpedance method, using a segmented bioimpedance meter. The measurements were carried out under fasting conditions for at least 4 hours, without having performed physical exercise in the last 12 hours, without consuming stimulating drinks such as caffeine and avoiding the menstrual period. From the body composition information, the data Percentage of Fat Mass, Kilos of Fat Mass and Kilos of Lean Mass were recorded.

The level of physical activity was assessed through a self-report questionnaire of physical activity and sitting time in the last 7 days, using the abbreviated version of the International Physical Activity Questionnaire (. The questionnaire was administered by a physical activity professional, and the data were reported in minutes per day to estimate the total PA performed, and the time reported was corrected by its metabolic equivalent .

The type of diet was corroborated through a quantified food consumption trend survey, which included 14 groups; vegetables, fruits, dairy and vegetable options, meat-fish-seafood and egg, legumes, vegan protein preparations, grains and cereals, fats and oils, nuts, sugars and sweets, alcohol, snacks, coffee and infusions, food supplements. The questionnaire was administered individually by a dietitian nutritionist to each participant.

Conditions

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Physical Activity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study consisted of a 4-arm non-randomized controlled clinical trial, with measurements at the beginning and end of a 16-week intervention.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Vegan Intervention

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.

Group Type EXPERIMENTAL

Strength training program

Intervention Type OTHER

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.

omnivorous intervention

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.

Group Type EXPERIMENTAL

Strength training program

Intervention Type OTHER

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 control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

omnivorous control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strength training program

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.

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Concepcion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael E Zapata Lamana, Doctor

Role: STUDY_DIRECTOR

Universidad de Concepcion

Locations

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Richar Carcamo Regla

Concepción, Concepcion, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type BACKGROUND
PMID: 32332862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33599941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35418173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8432116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37062484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34836139 (View on PubMed)

Other Identifiers

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CEBB 1068-2021

Identifier Type: -

Identifier Source: org_study_id

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