Acute Metabolic Response Versus Long-term Adaptation to a Vegan Diet: a Prospective Study of Metabolic Health, Body Composition and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The difference in body weight (kg), between healthy vegans (more than 2 years) and omnivores.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The difference in body weight (kg), between healthy vegans (more than 2 years) and omnivores.
时间窗: 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).
时间窗: 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.
时间窗: 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.
时间窗: 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).
时间窗: 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).
时间窗: 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).
次要结局
- World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)(From baseline to the end of intervention at 4 weeks)
- Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM).(From baseline to the end of intervention at 4 weeks.)
- Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10).(From baseline to the end of intervention at 4 weeks.)
- Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QoL).(From baseline to the end of intervention at 4 weeks.)
- Patient Health Questionnaire-15 (PHQ-15).(From baseline to the end of intervention at 4 weeks.)
研究者
Matej Vnucak
Investigator
University Hospital, Martin