Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Changes in Rathus Assertiveness Schedule
研究概览
简要总结
The main medical and social purpose of the project "It's trendy to be healthy!" is the promotion of healthy lifestyles and healthy eating among student youth. The relevance of this project is beyond doubt, as the WHO called obesity a non-communicable epidemic, and according to research by the Jane Schiller University of Germany (Germany), as mentioned above, Ukraine topped the list of the countries with high mortality due to malnutrition
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •medical students aged between 18-25 years;
- •presence of presence of vitamin D deficiency or insuficiency (serum total vit D3 level less than );
- •signed informed consent.
排除标准
- •regular intake of probiotics, prebiotics, antibiotics, anticonvulsants, calcium and vit. D supplements for 3 months prior the inclusion;
- •previously diagnosed allergy to gut microbiota-based therapy; gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis;
- •suffering from any psychiatric illness; presence of diabetes mellitus, chronic cardiovascular or respiratory disease, an active malignant tumor or chronic infections; participation in another clinical trial;
- •pregnancy or lactation;
- •any condition thought to be associated with poor compliance (e.g., alcoholism or drug addiction) or any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.
结局指标
主要结局
Changes in Rathus Assertiveness Schedule
时间窗: 90 days compared to baseline
RAS is consists of 30 questions and is divided into five subgroups, according to the scores: 0-24: very insecure; 25-48: rather unsure than confident; 49-72: average confidence value; 73-96: self-confident and 97-120: overconfident.
Changes in test "Diagnosis of situational and personal anxiety"
时间窗: 90 days compared to baseline
Test " Diagnosis of situational and personal anxiety" by Ch. D. Spielberger consists of 20 statements that refer to anxiety as a state (state of anxiety, reactive (RA) or situational anxiety (SA)) and 20 statements to define anxiety as a disposition, personality traits (anxiety property).
次要结局
- weight(at 45 and 90 days compared to baseline)
- waist circumferences (WC)(at 45 and 90 days compared to baseline)
- body mass index (BMI)(at 45 and 90 days compared to baseline)
- muscle mass(at 45 and 90 days compared to baseline)
- fat content(at 45 and 90 days compared to baseline)
- systolic blood pressure (SBP)(at 45 and 90 days compared to baseline)
- diastolic blood pressure (DBP)(at 45 and 90 days compared to baseline)
- HbA1c(90 days compared to baseline)
- fasting plasma glucose (FPG)(90 days compared to baseline)
- total cholesterol (TC)(90 days compared to baseline)
- Total vitamin D3(90 days compared to baseline)
研究者
Nazarii Kobyliak
Associate Professor, Endocrinology Department
Bogomolets National Medical University