Body Composition, Cardiometabolic Health, Quality of Life (QOL), Vegan Diet
Conditions
Keywords
vegan diet, dietary intervention, body composition, metabolic adaptation, quality of life
Brief 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, 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.
Interventions
DIETARY_SUPPLEMENTvegan diet
omnivores transmitted to vegan diet
Sponsors
University Hospital, Martin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Active infection * Eating disorder * Severe or unstable metabolic disease (e.g., diabetes mellitus) * Endocrine disorders * BMI \< 18 or \> 30 kg/m² * Age \< 18 years * Current or past malignancy * Systemic corticosteroid therapy * Hormone replacement therapy * Pregnancy * Inability to complete follow-up assessments * Excessive alcohol consumption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in body weight (kg), between healthy vegans (more than 2 years) and omnivores. | 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). | 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. | 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. | 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). | 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). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) | From baseline to the end of intervention at 4 weeks | 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). |
| Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM). | From baseline to the end of intervention at 4 weeks. | 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). |
| Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10). | From baseline to the end of intervention at 4 weeks. | 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). |
| Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL). | From baseline to the end of intervention at 4 weeks. | 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). |
| Patient Health Questionnaire-15 (PHQ-15). | From baseline to the end of intervention at 4 weeks. | 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). |
Countries
Slovakia
Outcome results
None listed