Vegan DietVITALNCT07731633
Acute Metabolic Response Versus Long-term Adaptation to a Vegan Diet
A study testing vegan diet in people with Vegan Diet and Body Composition, run by University Hospital, Martin at 1 site in Slovakia.
Trial summary
At baseline, venous blood samples were collected from all eligible participants. The following biochemical parameters were analysed: serum electrolytes (mineral profile), fasting glucose, creatinine, urea nitrogen, total proteins, albumin, bilirubin, liver enzymes, C-reactive protein (CRP), total cholesterol… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vegan Diet, Body Composition, Quality of Life (QOL)
- What is being tested?
- vegan diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSlovakia
- Study dates
- 16 Feb 2023to 5 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Healthy individuals without chronic disease
- BMI between 18 and 30 kg/m²
- Provision of written informed consent
- For the VEG-P group: exclusive adherence to a plant-based diet for at least 2 years
- For the WD group: regular consumption of animal products for at least 2 years
- For the intervention group (VEG): willingness to adhere to complete exclusion of animal products for the duration of the study
Who cannot join
- Active infection
- Eating disorder
- Severe or unstable metabolic disease (e.g., diabetes mellitus)
- Endocrine disorders
- BMI < 18 or > 30 kg/m²
- Age < 18 years
Show all 12Show fewer
- Current or past malignancy
- Systemic corticosteroid therapy
- Hormone replacement therapy
- Pregnancy
- Inability to complete follow-up assessments
- Excessive alcohol consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Metabolic Response Versus Long-term Adaptation to a Vegan Diet: a Prospective Study of Metabolic Health, Body Composition and Quality of Life
At baseline, venous blood samples were collected from all eligible participants. The following biochemical parameters were analysed: serum electrolytes (mineral profile), fasting glucose, creatinine, urea nitrogen, total proteins, albumin, bilirubin, liver enzymes, C-reactive protein (CRP), total cholesterol, triacylglycerols (TAG), serum iron, active vitamin D, vitamin B12, complete blood count.
At baseline, all participants also underwent standardized anthropometric measurements, including height (cm), body weight (kg) and BMI was calculated accordingly. Body composition was assessed using bioelectrical impedance analysis with the InBody Tanita MC-780MA device. The following parameters were recorded: total body fat (kg, %), visceral fat (kg, %), skeletal muscle mass (kg, %), total muscle mass (kg, %), total body water (kg, %), sarcopenic index (kg/m²), phase angle.
Read more
To assess health-related quality of life and symptom burden, all participants completed validated questionnaires: World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM), Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL) and Patient Health Questionnaire-15 (PHQ-15).
After the one-month intervention, participants in the VEG group repeated laboratory testing, anthropometric assessment, body composition analysis, and questionnaire evaluation. The same follow-up assessments were performed in the WD group for comparative purposes. Long-term vegans (VEG-P) did not undergo repeated measurements.
Dietary Monitoring and Adherence At study enrolment, all participants were offered a dietary consultation to improve adherence to the assigned dietary regimen. Participants were also instructed to maintain a food diary throughout the study period, which was periodically reviewed via telephone or email consultation.
- Being tested
- vegan diet
- Keywords
- vegan diet, dietary intervention, body composition, metabolic adaptation, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegan dietDietary supplement
omnivores transmitted to vegan diet
| Study group | Role | What they receive |
|---|---|---|
| VEG | Experimental | omnivores transmitted to vegan diet Receives: Dietary Supplement: vegan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in body weight (kg), between healthy vegans (more than 2 years) and omnivores.
To comprehensively compare body weight among individuals following different dietary patterns (long-term vegans and omnivores).
Measured: Baseline
The difference in body weight (kg) between omnivores and intervention group (omnivores transitioned to vegan diet).
To comprehensively compare body weight among individuals following different dietary patterns (long-term omnivores and intervention group).
Measured: From baseline to the end of intervention at 4 weeks
The difference in lipid profile (total cholesterol, triglycerides), between healthy vegans (more than 2 years) and omnivores.
At baseline, venous blood samples were collected from all eligible participants to analyse lipid profile: total cholesterol (mmol/l), triaglycerides (mmol/l).
Measured: Baseline
The difference in C-reactive protein (CRP), between healthy vegans (more than 2 years) and omnivores.
At baseline, venous blood samples were collected from all eligible participants to analyse CRP (mg/l).
Measured: Baseline
The difference in lipid profile (total cholesterol, triglycerides) between omnivores and intervention group (omnivores transitioned to vegan diet).
To comprehensively compare lipid profile parameters among individuals following different dietary patterns (long-term omnivores and intervention group). Venous blood samples were analyzed to measure total cholesterol (mmol/l) and triglycerides (mmol/l).
Measured: From baseline to the end of intervention at 4 weeks
The difference in C-reactive protein (CRP) between omnivores and intervention group (omnivores transitioned to vegan diet).
To comprehensively compare CRP parameters among individuals following different dietary patterns (long-term omnivores and intervention group). Venous blood samples were analyzed to measure CRP (mg/l).
Measured: From baseline to the end of intervention at 4 weeks.
Secondary outcomes (5)
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
To evaluate a difference in health-related quality of life using World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), among individuals following different dietary patterns (long-term omnivores and intervention group - omnivores trasmitted to vegan diet).
Measured: From baseline to the end of intervention at 4 weeks
Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM).
To evaluate a difference in health-related quality of life using Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM), among individuals following different dietary patterns (long-term omnivores and intervention group - omnivores trasmitted to vegan diet).
Measured: From baseline to the end of intervention at 4 weeks.
Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10).
To evaluate a difference in health-related quality of life using Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), among individuals following different dietary patterns (long-term omnivores and intervention group - omnivores trasmitted to vegan diet).
Measured: From baseline to the end of intervention at 4 weeks.
Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL).
To evaluate a difference in health-related quality of life using Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL), among individuals following different dietary patterns (long-term omnivores and intervention group - omnivores trasmitted to vegan diet).
Measured: From baseline to the end of intervention at 4 weeks.
Patient Health Questionnaire-15 (PHQ-15).
To evaluate a difference in health-related quality of life using Patient Health Questionnaire-15 (PHQ-15), among individuals following different dietary patterns (long-term omnivores and intervention group - omnivores trasmitted to vegan diet).
Measured: From baseline to the end of intervention at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start16 Feb 2023
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vegan DietStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731633
- Sponsor's protocol ID
- EK 73/2022
- Acronym
- VITAL
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Metabolic Response Versus Long-term Adaptation to a Vegan Diet: a Prospective Study of Metabolic Health, Body Composition and Quality of Life
- ClinicalTrials.gov ID
- NCT07731633
- Acronym / sponsor ID
- VITAL / EK 73/2022
- Keywords
- vegan diet, dietary intervention, body composition, metabolic adaptation, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 28 Jul 2026 (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.
At baseline, venous blood samples were collected from all eligible participants. The following biochemical parameters were analysed: serum electrolytes (mineral profile), fasting glucose, creatinine, urea nitrogen, total proteins, albumin, bilirubin, liver enzymes, C-reactive protein (CRP), total cholesterol, triacylglycerols (TAG), serum iron, active vitamin D, vitamin B12, complete blood count.
At baseline, all participants also underwent standardized anthropometric measurements, including height (cm), body weight (kg) and BMI was calculated accordingly. Body composition was assessed using bioelectrical impedance analysis with the InBody Tanita MC-780MA device. The following parameters were recorded: total body fat (kg, %), visceral fat (kg, %), skeletal muscle mass (kg, %), total muscle mass (kg, %), total body water (kg, %), sarcopenic index (kg/m²), phase angle.
To assess health-related quality of life and symptom burden, all participants completed validated questionnaires: World Health Organization Quality of Life - Brief Version (WHOQOL-BREF), Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM), Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10), Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL) and Patient Health Questionnaire-15 (PHQ-15).
After the one-month intervention, participants in the VEG group repeated laboratory testing, anthropometric assessment, body composition analysis, and questionnaire evaluation. The same follow-up assessments were performed in the WD group for comparative purposes. Long-term vegans (VEG-P) did not undergo repeated measurements.
Dietary Monitoring and Adherence At study enrolment, all participants were offered a dietary consultation to improve adherence to the assigned dietary regimen. Participants were also instructed to maintain a food diary throughout the study period, which was periodically reviewed via telephone or email consultation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEG | Experimental | Dietary Supplement: vegan dietomnivores transmitted to vegan diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Healthy individuals without chronic disease
- BMI between 18 and 30 kg/m²
- Provision of written informed consent
- For the VEG-P group: exclusive adherence to a plant-based diet for at least 2 years
Key exclusion criteria (12 listed)
- Active infection
- Eating disorder
- Severe or unstable metabolic disease (e.g., diabetes mellitus)
- Endocrine disorders
- BMI < 18 or > 30 kg/m²
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 |
|---|---|---|
| vegan dietomnivores transmitted to vegan diet | Dietary supplement | VEG |
Primary outcome
The difference in body weight (kg), between healthy vegans (more than 2 years) and omnivores.
Time frame: Baseline
To comprehensively compare body weight among individuals following different dietary patterns (long-term vegans and omnivores).
The difference in body weight (kg) between omnivores and intervention group (omnivores transitioned to vegan diet).
Time frame: From baseline to the end of intervention at 4 weeks
To comprehensively compare body weight among individuals following different dietary patterns (long-term omnivores and intervention group).
The difference in lipid profile (total cholesterol, triglycerides), between healthy vegans (more than 2 years) and omnivores.
Time frame: Baseline
At baseline, venous blood samples were collected from all eligible participants to analyse lipid profile: total cholesterol (mmol/l), triaglycerides (mmol/l).
The difference in C-reactive protein (CRP), between healthy vegans (more than 2 years) and omnivores.
Time frame: Baseline
At baseline, venous blood samples were collected from all eligible participants to analyse CRP (mg/l).
The difference in lipid profile (total cholesterol, triglycerides) between omnivores and intervention group (omnivores transitioned to vegan diet).
Time frame: From baseline to the end of intervention at 4 weeks
To comprehensively compare lipid profile parameters among individuals following different dietary patterns (long-term omnivores and intervention group). Venous blood samples were analyzed to measure total cholesterol (mmol/l) and triglycerides (mmol/l).
The difference in C-reactive protein (CRP) between omnivores and intervention group (omnivores transitioned to vegan diet).
Time frame: From baseline to the end of intervention at 4 weeks.
To comprehensively compare CRP parameters among individuals following different dietary patterns (long-term omnivores and intervention group). Venous blood samples were analyzed to measure CRP (mg/l).
5 secondary outcomes
World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
Time frame: From baseline to the end of intervention at 4 weeks
Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM).
Time frame: From baseline to the end of intervention at 4 weeks.
Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10).
Time frame: From baseline to the end of intervention at 4 weeks.
Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL).
Time frame: From baseline to the end of intervention at 4 weeks.
Patient Health Questionnaire-15 (PHQ-15).
Time frame: From baseline to the end of intervention at 4 weeks.
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vegan diet in people with Vegan Diet and Body Composition, run by University Hospital, Martin at 1 site in Slovakia.
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 7 inclusion and 12 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 28 Jul 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 Slovakia. 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?
The difference in body weight (kg), between healthy vegans (more than 2 years) and omnivores. (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.