Healthy, Nutrition, Healthy, Obesity, Vitamin D Deficiency
Conditions
Keywords
gut microbiota, vitamin D, personalized nutrition, lifestyle in students, synbiotic, depression
Brief summary
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
Interventions
OTHERnutrition program and modification of physical activity
nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)
DIETARY_SUPPLEMENTsynbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)
one synbiotic sachet (3g), BID, for 3 month traetment
DIETARY_SUPPLEMENTvitamin D3
vitamin D3, oral, 2000IU BID, for 3 month treatment
Sponsors
Taras Shevchenko National University of Kyiv
Bogomolets National Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Rathus Assertiveness Schedule | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body mass index (BMI) | at 45 and 90 days compared to baseline | weight in kg and height in meters will be combined to report BMI in kg/m\^2 |
| muscle mass | at 45 and 90 days compared to baseline | muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601 |
| fat content | at 45 and 90 days compared to baseline | fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601 |
| systolic blood pressure (SBP) | at 45 and 90 days compared to baseline | Blood pressure is measured from the right hand while sitting with the help of a mercury barometer OMRON. Blood pressure is taken twice at a 5-minute interval while seated for 5 minutes. |
| weight | at 45 and 90 days compared to baseline | weight in kg |
| HbA1c | 90 days compared to baseline | HbA1c in % |
| fasting plasma glucose (FPG) | 90 days compared to baseline | FPG in mmol/L |
| total cholesterol (TC) | 90 days compared to baseline | TC in mmol/L |
| Total vitamin D3 | 90 days compared to baseline | Total vitamin D3, ng/ml |
| diastolic blood pressure (DBP) | at 45 and 90 days compared to baseline | Blood pressure is measured from the right hand while sitting with the help of a mercury barometer OMRON. Blood pressure is taken twice at a 5-minute interval while seated for 5 minutes. |
| waist circumferences (WC) | at 45 and 90 days compared to baseline | WC in cm |
Countries
Ukraine
Outcome results
None listed