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

Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students

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

Study Overview

• Status: Completed
• Conditions: Healthy; Obesity; Vitamin D Deficiency; Nutrition, Healthy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine, 01601
    • Bogomolets National Medical University
  • Kyiv, Ukraine, 01601
    • Taras Shevchenko National University of Kyiv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days compared to baseline
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).	90 days compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight in kg	at 45 and 90 days compared to baseline
waist circumferences (WC)	WC in cm	at 45 and 90 days compared to baseline
body mass index (BMI)	weight in kg and height in meters will be combined to report BMI in kg/m^2	at 45 and 90 days compared to baseline
muscle mass	muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601	at 45 and 90 days compared to baseline
fat content	fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601	at 45 and 90 days compared to baseline
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.	at 45 and 90 days compared to baseline
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.	at 45 and 90 days compared to baseline
HbA1c	HbA1c in %	90 days compared to baseline
fasting plasma glucose (FPG)	FPG in mmol/L	90 days compared to baseline
total cholesterol (TC)	TC in mmol/L	90 days compared to baseline
Total vitamin D3	Total vitamin D3, ng/ml	90 days compared to baseline

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): November 10, 2019

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: depression; synbiotic; vitamin D; gut microbiota; personalized nutrition; lifestyle in students
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: ENDO-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No