Physical ActivityVeganNCT06423209
Efficacy of a Training Program in Adults Following a Vegan Diet Versus an Omnivorous Diet
A study testing Strength training program in people with Physical Activity, run by Universidad de Concepcion at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Strength training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChile
- Study dates
- 2 Feb 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 59 years.
- Residing in the Biobío or Araucanía regions of Chile.
- Following a vegan diet or an omnivorous diet for at least 6 months.
Who cannot join
- Diagnosed diabetes.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg).
- Undergoing cancer treatment.
- Chronic kidney disease.
- Health issues identified through the pre-exercise aptitude questionnaire (PAR-Q).
- Participation in an exercise program.
- More than 3 hours of vigorous exercise per week.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Omnivorous Versus a Vegan Diet in the Prevention or Treatment of Sarcopenia in Chilean Adults Following a Strength Training Program
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.
Read the detailed description
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
- Physical Activity
- Being tested
- Strength training program
- Keywords
- vegan diet, omnivorous diet, strength training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (kg) measured using the InBody 120
Difference in body weight (kg) between baseline and after 16 weeks of intervention, measured using the InBody 120 bioelectrical impedance analyzer.
Measured: From baseline to 16 weeks of intervention
Change in waist circumference (cm) measured using a measuring tape
Difference in waist circumference (cm) between baseline and after 16 weeks of intervention, measured using a non-elastic measuring tape.
Measured: From baseline to 16 weeks of intervention
Change in body fat percentage (%) measured using the InBody 120
Difference in body fat percentage (%) between baseline and after 16 weeks of intervention, measured using the InBody 120 bioelectrical impedance analyzer.
Measured: From baseline to 16 weeks of intervention
Change in lean mass (kg) measured using the InBody 120
Difference in lean mass (kg) between baseline and after 16 weeks of intervention, measured using the InBody 120 bioelectrical impedance analyzer.
Measured: From baseline to 16 weeks of intervention
Change in one-repetition maximum (1RM) biceps curl strength (kg)
Difference in one-repetition maximum (1RM) biceps curl strength (kg) between baseline and after 16 weeks of intervention, assessed using a biceps curl 1RM test.
Measured: From baseline to 16 weeks of intervention
Change in handgrip strength (kg) measured using a hydraulic dynamometer
Difference in handgrip strength (kg) between baseline and after 16 weeks of intervention, measured using a hydraulic dynamometer in both hands.
Measured: From baseline to 16 weeks of intervention
Change in vertical jump height (cm)
Difference in vertical jump height (cm) between baseline and after 16 weeks of intervention, measured using a metric tape fixed to a wall.
Measured: From baseline to 16 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start2 Feb 2022
- Primary completion2 May 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consisted of a 4-arm non-randomized controlled clinical trial, with measurements at the beginning and end of a 16-week intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Concepcion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael E Zapata Lamana, Doctor, Study director, Universidad de Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423209
- Sponsor's protocol ID
- CEBB 1068-2021
- Acronym
- Vegan
- Status last verified
- Oct 2026
- First submitted
- 15 May 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Has not been considered or discussed yet
Publications
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.
PubMed 32332862Hevia-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.
PubMed 33599941Reid-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.
PubMed 35418173van 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.
PubMed 8432116Hannaian 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.
PubMed 37062484Pohl 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.
PubMed 34836139
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Omnivorous Versus a Vegan Diet in the Prevention or Treatment of Sarcopenia in Chilean Adults Following a Strength Training Program
- ClinicalTrials.gov ID
- NCT06423209
- Acronym / sponsor ID
- Vegan / CEBB 1068-2021
- Conditions
- Physical Activity
- Keywords
- vegan diet, omnivorous diet, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Universidad de ConcepcionUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study consisted of a 4-arm non-randomized controlled clinical trial, with measurements at the beginning and end of a 16-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Vegan Intervention | Experimental | Other: Strength training programThe 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. |
| omnivorous intervention | Experimental | Other: Strength training programThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 59 years.
- Residing in the Biobío or Araucanía regions of Chile.
- Following a vegan diet or an omnivorous diet for at least 6 months.
Key exclusion criteria (7 listed)
- Diagnosed diabetes.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg).
- Undergoing cancer treatment.
- Chronic kidney disease.
- Health issues identified through the pre-exercise aptitude questionnaire (PAR-Q).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training programStrength 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. | Other | Vegan Intervention, omnivorous intervention |
Primary outcome
Change in body weight (kg) measured using the InBody 120
Time frame: From baseline to 16 weeks of intervention
Difference in body weight (kg) between baseline and after 16 weeks of intervention, measured using the InBody 120 bioelectrical impedance analyzer.
Change in waist circumference (cm) measured using a measuring tape
Time frame: From baseline to 16 weeks of intervention
Difference in waist circumference (cm) between baseline and after 16 weeks of intervention, measured using a non-elastic measuring tape.
Change in body fat percentage (%) measured using the InBody 120
Time frame: From baseline to 16 weeks of intervention
Difference in body fat percentage (%) between baseline and after 16 weeks of intervention, measured using the InBody 120 bioelectrical impedance analyzer.
Change in lean mass (kg) measured using the InBody 120
Time frame: From baseline to 16 weeks of intervention
Difference in lean mass (kg) between baseline and after 16 weeks of intervention, measured using the InBody 120 bioelectrical impedance analyzer.
Change in one-repetition maximum (1RM) biceps curl strength (kg)
Time frame: From baseline to 16 weeks of intervention
Difference in one-repetition maximum (1RM) biceps curl strength (kg) between baseline and after 16 weeks of intervention, assessed using a biceps curl 1RM test.
Change in handgrip strength (kg) measured using a hydraulic dynamometer
Time frame: From baseline to 16 weeks of intervention
Difference in handgrip strength (kg) between baseline and after 16 weeks of intervention, measured using a hydraulic dynamometer in both hands.
Change in vertical jump height (cm)
Time frame: From baseline to 16 weeks of intervention
Difference in vertical jump height (cm) between baseline and after 16 weeks of intervention, measured using a metric tape fixed to a wall.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 32332862Boutros 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.
- Background: PubMed 33599941Hevia-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.
- Background: PubMed 35418173Reid-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.
- Background: PubMed 8432116van 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.
- Background: PubMed 37062484Hannaian 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.
- Background: PubMed 34836139Pohl 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.
- Individual participant dataSharing planned: No. Has not been considered or discussed yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael E Zapata Lamana, Doctor study director
Universidad de Concepcion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training program in people with Physical Activity, run by Universidad de Concepcion at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (kg) measured using the InBody 120 (time frame: From baseline to 16 weeks of intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423209, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.