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

NCT05073029 | Completed

• 1 other identifier: ENDO-7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Keywords

gut microbiota; vitamin D; personalized nutrition; lifestyle in students; synbiotic; depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• weight

  at 45 and 90 days compared to baseline

• waist circumferences (WC)

  at 45 and 90 days compared to baseline

• body mass index (BMI)

  at 45 and 90 days compared to baseline

• muscle mass

  at 45 and 90 days compared to baseline

• fat content

  at 45 and 90 days compared to baseline

Study Arms (2)

standard care group

ACTIVE COMPARATOR

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

intervention group

EXPERIMENTAL

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); Dietary Supplement: vitamin D3

Interventions

nutrition program and modification of physical activity OTHER

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

standard care group

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

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

Also known as: Acidolac

intervention group

vitamin D3 DIETARY_SUPPLEMENT

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

Also known as: Olidetrim

intervention group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bogomolets National Medical University: lead
• Taras Shevchenko National University of Kyiv: collaborator

Study Sites (2)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

Taras Shevchenko National University of Kyiv

Kyiv, 01601, Ukraine

Location

MeSH Terms

Conditions

Obesity; Vitamin D Deficiency; Depression

Interventions

Synbiotics; Cholecalciferol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nataliia Molochek, PhD

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

  STUDY DIRECTOR

• Liudmyla Ostapchenko, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Endocrinology Department

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 11, 2021
• Study Start: February 10, 2019
• Primary Completion: September 10, 2019
• Study Completion: November 10, 2019
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)