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

Bogomolets National Medical University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05073029

ENDO-7

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

standard care group

Active Comparator group

Description:

3-month course of individually selected nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)

Treatment:

Other: nutrition program and modification of physical activity

intervention group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)

Dietary Supplement: vitamin D3