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OpenTrials
Completed

NCT Number: NCT05073029

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

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Key information

Conditions

Healthy Avitaminosis Behavior Behavioral Symptoms Body Weight Deficiency Diseases Depression Malnutrition Nutrition Disorders Nutrition, Healthy Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin D Deficiency

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bogomolets National Medical University, Kyiv, Ukraine

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nutrition program and modification of physical activity

Other

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

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

Dietary Supplement

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

Other names: Acidolac

Vitamin D3

Dietary Supplement

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

Other names: Olidetrim

Primary outcomes

  1. Changes in Rathus Assertiveness Schedule

    Time frame: 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"

    Time frame: 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 outcomes

  1. weight

    Time frame: at 45 and 90 days compared to baseline

    weight in kg

  2. waist circumferences (WC)

    Time frame: at 45 and 90 days compared to baseline

    WC in cm

  3. body mass index (BMI)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 90 days compared to baseline

    HbA1c in %

  9. fasting plasma glucose (FPG)

    Time frame: 90 days compared to baseline

    FPG in mmol/L

  10. total cholesterol (TC)

    Time frame: 90 days compared to baseline

    TC in mmol/L

  11. Total vitamin D3

    Time frame: 90 days compared to baseline

    Total vitamin D3, ng/ml

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Collaborators

  • Taras Shevchenko National University of Kyiv

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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