Influence of Liquid Multivitamin Supplementation on Life Quality, Mood, Perception of Stress and Health-related Vital and Blood Parameters and the Immune System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Plasma concentration of Vitamin B12
研究概览
简要总结
In this study the investigator will evaluate whether a liquid multivitamin supplement influences blood and vital parameters. Furthermore the investigator will establish the effects on life quality, mood and perception of stress and will characterize changes on immune system.
详细描述
The double-blind, randomized intervention study is conducted for 12 weeks and includes two groups (placebo versus verum) with same number of participants.
The investigator aims to determine the effects of multivitamin supplement on blood and vital parameters which includes blood pressure, pulse, heart rate, variability of heart rate, vitamin D, vitamin B12, folic acid, homocysteine, HbA1c. Furthermore the investigator will access life quality, mood and perception of stress through the following questionnaire POMS, PSS-10, SF12 & SF36. The investigator will evaluate whether the multivitamin supplement changes the frequency of diseases like cold which represents the function of the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy women and men
- •age between 30-60 years
排除标准
- •acute and chronic diseases (including diabetes, inflammatory bowel diseases, dementia, multiple sclerosis)
- •frequent use of alcohol, drugs or cigarettes (>5 cigarettes / day)
- •use of additional supplements
- •use of medications (e.g. antihypertensive medications, lipid reducers, thyroid medication)
结局指标
主要结局
Plasma concentration of Vitamin B12
时间窗: change measures (baseline to 12 weeks)
vitamin B12 \[pmol/l\]
次要结局
- Analysis of blood pressure(change measures (baseline to 12 weeks))
- Analysis of heart rate variability(change measures (baseline to 12 weeks))
- Analysis of speed of pulse wave,(change measures (baseline to 12 weeks))
- Plasma concentration of 25-hydroxyvitamin D(change measures (baseline to 12 weeks))
- Plasma concentration of folic acid(change measures (baseline to 12 weeks))
- Plasma concentration of homocysteine(change measures (baseline to 12 weeks))
- Plasma concentration of HbA1c(change measures (baseline to 12 weeks))
研究者
Kuno Hottenrott, Prof.
Prof. Dr.; University of Halle-Wittenberg, Department of Sports
Martin-Luther-Universität Halle-Wittenberg