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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073029
• Other study ID #: ENDO-7
• Status: Completed
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: November 10, 2019

Study information

• Verified date: October 2021
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Obesity
• Vitamin D Deficiency

Intervention

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

Dietary Supplement:
• synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0?109 colony forming units - CFU)
one synbiotic sachet (3g), BID, for 3 month traetment
• vitamin D3
vitamin D3, oral, 2000IU BID, for 3 month treatment

Locations

Country	Name	City	State
Ukraine	Bogomolets National Medical University	Kyiv
Ukraine	Taras Shevchenko National University of Kyiv	Kyiv

Sponsors (2)

Lead Sponsor	Collaborator
Bogomolets National Medical University	Taras Shevchenko National University of Kyiv

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	weight	weight in kg	at 45 and 90 days compared to baseline
Secondary	waist circumferences (WC)	WC in cm	at 45 and 90 days compared to baseline
Secondary	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
Secondary	muscle mass	muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601	at 45 and 90 days compared to baseline
Secondary	fat content	fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601	at 45 and 90 days compared to baseline
Secondary	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
Secondary	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
Secondary	HbA1c	HbA1c in %	90 days compared to baseline
Secondary	fasting plasma glucose (FPG)	FPG in mmol/L	90 days compared to baseline
Secondary	total cholesterol (TC)	TC in mmol/L	90 days compared to baseline
Secondary	Total vitamin D3	Total vitamin D3, ng/ml	90 days compared to baseline