HealthyNCT05073029
Open Label Randomized Clinical Study to Promote a Healthy Lifestyle in Medical Students
A study testing nutrition program and modification of physical activity, synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU) and vitamin D3 in people with Healthy and Obesity, run by Bogomolets National Medical University at 2 sites in Ukraine.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Nutrition, Healthy
- What is being tested?
- nutrition program and modification of physical activity, synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU) and vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUkraine
- Study dates
- 10 Feb 2019to 10 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Bogomolets National Medical University
Kyiv, 01601
Taras Shevchenko National University of Kyiv
Kyiv, 01601
About this study
Official title: 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
- Conditions
- Healthy, Obesity, Nutrition, Healthy, Vitamin D Deficiency
- Being tested
- nutrition program and modification of physical activity, synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU), vitamin D3
- Keywords
- gut microbiota, vitamin D, personalized nutrition, lifestyle in students, synbiotic, depression
- Medical subject headings
- Obesity, Vitamin D Deficiency, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition program and modification of physical activityOther
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
Also called Acidolac
one synbiotic sachet (3g), BID, for 3 month traetment
vitamin D3Dietary supplement
Also called Olidetrim
vitamin D3, oral, 2000IU BID, for 3 month treatment
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU); Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 90 days compared to baseline
Secondary outcomes (11)
weight
weight in kg
Measured: at 45 and 90 days compared to baseline
waist circumferences (WC)
WC in cm
Measured: 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
Measured: at 45 and 90 days compared to baseline
muscle mass
muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601
Measured: at 45 and 90 days compared to baseline
fat content
fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601
Measured: 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.
Measured: 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.
Measured: at 45 and 90 days compared to baseline
HbA1c
HbA1c in %
Measured: 90 days compared to baseline
fasting plasma glucose (FPG)
FPG in mmol/L
Measured: 90 days compared to baseline
total cholesterol (TC)
TC in mmol/L
Measured: 90 days compared to baseline
Total vitamin D3
Total vitamin D3, ng/ml
Measured: 90 days compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start10 Feb 2019
- Primary completion10 Sep 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv
- Responsible party
- Principal investigator, Nazarii Kobyliak, Bogomolets National Medical University
- Investigators
- Nataliia Molochek, PhD, Study director, ESC "Institute of Biology and Medicine", Taras Shevchenko National University of KyivLiudmyla Ostapchenko, Professor, Study chair, ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073029
- Sponsor's protocol ID
- ENDO-7
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutrition, Physical Activity and Therapy to Modulate Gut Microbiota: a Randomized Clinical Study to Promote a Healthy Lifestyle in Students
- ClinicalTrials.gov ID
- NCT05073029
- Acronym / sponsor ID
- ENDO-7
- Conditions
- Healthy, Obesity, Nutrition, Healthy, Vitamin D Deficiency
- Keywords
- gut microbiota, vitamin D, personalized nutrition, lifestyle in students, synbiotic, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care group | Active comparator | Other: nutrition program and modification of physical activity3-month course of individually selected nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily) |
| intervention group | Experimental | Dietary Supplement: synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU), Dietary Supplement: vitamin D3additionally 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition program and modification of physical activitynutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily) | Other | standard care group |
| synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)Also: Acidolacone synbiotic sachet (3g), BID, for 3 month traetment | Dietary supplement | intervention group |
| vitamin D3Also: Olidetrimvitamin D3, oral, 2000IU BID, for 3 month treatment | Dietary supplement | intervention group |
Primary outcome
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.
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).
11 secondary outcomes
weight
Time frame: at 45 and 90 days compared to baseline
waist circumferences (WC)
Time frame: at 45 and 90 days compared to baseline
body mass index (BMI)
Time frame: at 45 and 90 days compared to baseline
muscle mass
Time frame: at 45 and 90 days compared to baseline
fat content
Time frame: at 45 and 90 days compared to baseline
systolic blood pressure (SBP)
Time frame: at 45 and 90 days compared to baseline
diastolic blood pressure (DBP)
Time frame: at 45 and 90 days compared to baseline
HbA1c
Time frame: 90 days compared to baseline
fasting plasma glucose (FPG)
Time frame: 90 days compared to baseline
total cholesterol (TC)
Time frame: 90 days compared to baseline
Total vitamin D3
Time frame: 90 days compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nataliia Molochek, PhD study director
ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
Liudmyla Ostapchenko, Professor study chair
ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition program and modification of physical activity, synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU) and vitamin D3 in people with Healthy and Obesity, run by Bogomolets National Medical University at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Rathus Assertiveness Schedule (time frame: 90 days compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.