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

Not Applicable

Completed

• Conditions: Healthy; Vitamin D Deficiency; Obesity; Nutrition, Healthy
• Interventions: Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU); Other: nutrition program and modification of physical activity; Dietary Supplement: vitamin D3

• Registration Number: NCT05073029
• Lead Sponsor: Bogomolets National Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-10
• Primary Completion: 2019-09-10
• Study Completion: 2019-11-10
• Status Verified: 2021-10
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Study First Posted: 2021-10-11
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)	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.
standard care group	nutrition program and modification of physical activity	3-month course of individually selected nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)
intervention group	vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
weight	at 45 and 90 days compared to baseline	weight in kg
waist circumferences (WC)	at 45 and 90 days compared to baseline	WC in cm
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.
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.
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

Trial Locations

Locations (2)

Taras Shevchenko National University of Kyiv; 🇺🇦 Kyiv, Ukraine

Bogomolets National Medical University; 🇺🇦 Kyiv, Ukraine