Clinical trial NCT05073029: Open Label Randomized Clinical Study to Promote a Healthy Lifestyle in Medical Students
Official title: Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Obesity
Nutrition, Healthy
Vitamin D Deficiency
Keywords: gut microbiota
vitamin D
personalized nutrition
lifestyle in students
synbiotic
depression
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
Collaborators: name: Taras Shevchenko National University of Kyiv
First posted: 2021-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Rathus Assertiveness Schedule
timeFrame: 90 days compared to baseline
measure: Changes in test "Diagnosis of situational and personal anxiety"
timeFrame: 90 days compared to baseline
Secondary outcomes:
measure: weight
timeFrame: at 45 and 90 days compared to baseline
measure: waist circumferences (WC)
timeFrame: at 45 and 90 days compared to baseline
measure: body mass index (BMI)
timeFrame: at 45 and 90 days compared to baseline
measure: muscle mass
timeFrame: at 45 and 90 days compared to baseline
measure: fat content
timeFrame: at 45 and 90 days compared to baseline
measure: systolic blood pressure (SBP)
timeFrame: at 45 and 90 days compared to baseline
measure: diastolic blood pressure (DBP)
timeFrame: at 45 and 90 days compared to baseline
measure: HbA1c
timeFrame: 90 days compared to baseline
measure: fasting plasma glucose (FPG)
timeFrame: 90 days compared to baseline
measure: total cholesterol (TC)
timeFrame: 90 days compared to baseline
measure: Total vitamin D3
timeFrame: 90 days compared to baseline
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University
city: Kyiv
country: Ukraine
facility: Taras Shevchenko National University of Kyiv
Study officials:
affiliation: ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
name: Nataliia Molochek, PhD
role: STUDY_DIRECTOR
affiliation: ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
name: Liudmyla Ostapchenko, Professor
role: STUDY_CHAIR
References: