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

NCT ID: NCT05073029

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2019-11-10

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

Conditions

Healthy; Obesity; Nutrition, Healthy; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

standard care group

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

Group Type: ACTIVE_COMPARATOR

nutrition program and modification of physical activity

Intervention Type: OTHER

nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)

intervention group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

one synbiotic sachet (3g), BID, for 3 month traetment

vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

vitamin D3, oral, 2000IU BID, for 3 month treatment

Interventions

nutrition program and modification of physical activity

nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)

Intervention Type: OTHER

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

one synbiotic sachet (3g), BID, for 3 month traetment

Intervention Type: DIETARY_SUPPLEMENT

vitamin D3

vitamin D3, oral, 2000IU BID, for 3 month treatment

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Acidolac; Olidetrim

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taras Shevchenko National University of Kyiv

OTHER

Sponsor Role: collaborator

Bogomolets National Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nazarii Kobyliak

Associate Professor, Endocrinology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nataliia Molochek, PhD

Role: STUDY_DIRECTOR

ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv

Liudmyla Ostapchenko, Professor

Role: STUDY_CHAIR

ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv

Locations

Bogomolets National Medical University

Kyiv, , Ukraine

Taras Shevchenko National University of Kyiv

Kyiv, , Ukraine

Countries

Ukraine

Other Identifiers

ENDO-7

Identifier Type: -

Identifier Source: org_study_id