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

Primary Purpose

Healthy, Obesity, Nutrition, Healthy

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
nutrition program and modification of physical activity
synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)
vitamin D3
Sponsored by
Bogomolets National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring gut microbiota, vitamin D, personalized nutrition, lifestyle in students, synbiotic, depression

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard care group

intervention group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes in Rathus Assertiveness Schedule
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"
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

weight
weight in kg
waist circumferences (WC)
WC in cm
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m^2
muscle mass
muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601
fat content
fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601
systolic blood pressure (SBP)
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)
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
HbA1c in %
fasting plasma glucose (FPG)
FPG in mmol/L
total cholesterol (TC)
TC in mmol/L
Total vitamin D3
Total vitamin D3, ng/ml

Full Information

First Posted
October 8, 2021
Last Updated
October 8, 2021
Sponsor
Bogomolets National Medical University
Collaborators
Taras Shevchenko National University of Kyiv
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1. Study Identification

Unique Protocol Identification Number
NCT05073029
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
November 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bogomolets National Medical University
Collaborators
Taras Shevchenko National University of Kyiv

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obesity, Nutrition, Healthy, Vitamin D Deficiency
Keywords
gut microbiota, vitamin D, personalized nutrition, lifestyle in students, synbiotic, depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard care group
Arm Type
Active Comparator
Arm Description
3-month course of individually selected nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)
Arm Title
intervention group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
nutrition program and modification of physical activity
Intervention Description
nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)
Intervention Type
Dietary Supplement
Intervention Name(s)
synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)
Other Intervention Name(s)
Acidolac
Intervention Description
one synbiotic sachet (3g), BID, for 3 month traetment
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
Olidetrim
Intervention Description
vitamin D3, oral, 2000IU BID, for 3 month treatment
Primary Outcome Measure Information:
Title
Changes in Rathus Assertiveness Schedule
Description
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.
Time Frame
90 days compared to baseline
Title
Changes in test "Diagnosis of situational and personal anxiety"
Description
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).
Time Frame
90 days compared to baseline
Secondary Outcome Measure Information:
Title
weight
Description
weight in kg
Time Frame
at 45 and 90 days compared to baseline
Title
waist circumferences (WC)
Description
WC in cm
Time Frame
at 45 and 90 days compared to baseline
Title
body mass index (BMI)
Description
weight in kg and height in meters will be combined to report BMI in kg/m^2
Time Frame
at 45 and 90 days compared to baseline
Title
muscle mass
Description
muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601
Time Frame
at 45 and 90 days compared to baseline
Title
fat content
Description
fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601
Time Frame
at 45 and 90 days compared to baseline
Title
systolic blood pressure (SBP)
Description
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.
Time Frame
at 45 and 90 days compared to baseline
Title
diastolic blood pressure (DBP)
Description
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.
Time Frame
at 45 and 90 days compared to baseline
Title
HbA1c
Description
HbA1c in %
Time Frame
90 days compared to baseline
Title
fasting plasma glucose (FPG)
Description
FPG in mmol/L
Time Frame
90 days compared to baseline
Title
total cholesterol (TC)
Description
TC in mmol/L
Time Frame
90 days compared to baseline
Title
Total vitamin D3
Description
Total vitamin D3, ng/ml
Time Frame
90 days compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nataliia Molochek, PhD
Organizational Affiliation
ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Liudmyla Ostapchenko, Professor
Organizational Affiliation
ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
Official's Role
Study Chair
Facility Information:
Facility Name
Bogomolets National Medical University
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Taras Shevchenko National University of Kyiv
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

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

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