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

Sponsor
Bogomolets National Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05073029
Collaborator
Taras Shevchenko National University of Kyiv (Other)
120
Enrollment
2
Locations
2
Arms
9
Actual Duration (Months)
60
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
  • 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
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students
Actual Study Start Date :
Feb 10, 2019
Actual Primary Completion Date :
Sep 10, 2019
Actual Study Completion Date :
Nov 10, 2019

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: 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)

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

Experimental: 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.

Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)
one synbiotic sachet (3g), BID, for 3 month traetment
Other Names:
  • Acidolac
  • Dietary Supplement: vitamin D3
    vitamin D3, oral, 2000IU BID, for 3 month treatment
    Other Names:
  • Olidetrim
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. weight [at 45 and 90 days compared to baseline]

      weight in kg

    2. waist circumferences (WC) [at 45 and 90 days compared to baseline]

      WC in cm

    3. 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

    4. muscle mass [at 45 and 90 days compared to baseline]

      muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601

    5. fat content [at 45 and 90 days compared to baseline]

      fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601

    6. 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.

    7. 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.

    8. HbA1c [90 days compared to baseline]

      HbA1c in %

    9. fasting plasma glucose (FPG) [90 days compared to baseline]

      FPG in mmol/L

    10. total cholesterol (TC) [90 days compared to baseline]

      TC in mmol/L

    11. Total vitamin D3 [90 days compared to baseline]

      Total vitamin D3, ng/ml

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Bogomolets National Medical UniversityKyivUkraine01601
    2Taras Shevchenko National University of KyivKyivUkraine01601

    Sponsors and Collaborators

    • Bogomolets National Medical University
    • Taras Shevchenko National University of Kyiv

    Investigators

    • Study Director: Nataliia Molochek, PhD, ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
    • Study Chair: Liudmyla Ostapchenko, Professor, ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nazarii Kobyliak, Associate Professor, Endocrinology Department, Bogomolets National Medical University
    ClinicalTrials.gov Identifier:
    NCT05073029
    Other Study ID Numbers:
    • ENDO-7
    First Posted:
    Oct 11, 2021
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nazarii Kobyliak, Associate Professor, Endocrinology Department, Bogomolets National Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2021