Open Label Randomized Clinical Study to Promote a Healthy Lifestyle in Medical Students

Study Overview
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Brief Summary
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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

Official Title
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Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students

Conditions
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Healthy, Obesity, Nutrition, Healthy, Vitamin D Deficiency

Intervention / Treatment
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* Other: nutrition program and modification of physical activity
* Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)
* Dietary Supplement: vitamin D3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard care group<br>3-month course of individually selected nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily) | Other: nutrition program and modification of physical activity<br>* nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)<br>|
| Experimental: intervention group<br>additionally to previous group recieved treatment with synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103) and vitamin D3 - 2000 IU. The students were instructed to take vitamin D3 and synbiotic sachets twice a day for 3 months. | Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)<br>* one synbiotic sachet (3g), BID, for 3 month traetment<br>* Other names: Acidolac;Dietary Supplement: vitamin D3<br>* vitamin D3, oral, 2000IU BID, for 3 month treatment<br>* Other names: Olidetrim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Rathus Assertiveness Schedule | 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. | 90 days compared to baseline | 
| Changes in test Diagnosis of situational and personal anxiety | 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). | 90 days compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | weight in kg | at 45 and 90 days compared to baseline | 
| waist circumferences (WC) | WC in cm | at 45 and 90 days compared to baseline | 
| body mass index (BMI) | weight in kg and height in meters will be combined to report BMI in kg/m^2 | at 45 and 90 days compared to baseline | 
| muscle mass | muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601 | at 45 and 90 days compared to baseline | 
| fat content | fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601 | at 45 and 90 days compared to baseline | 
| systolic blood pressure (SBP) | 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. | at 45 and 90 days compared to baseline | 
| diastolic blood pressure (DBP) | 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. | at 45 and 90 days compared to baseline | 
| HbA1c | HbA1c in % | 90 days compared to baseline | 
| fasting plasma glucose (FPG) | FPG in mmol/L | 90 days compared to baseline | 
| total cholesterol (TC) | TC in mmol/L | 90 days compared to baseline | 
| Total vitamin D3 | Total vitamin D3, ng/ml | 90 days compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, vitamin D, personalized nutrition, lifestyle in students, synbiotic, depression