Healthy AgingFLIPSNCT05361343
First Line Prevent Age Study
A study testing 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement in people with Healthy Aging and Healthy Lifestyle, run by Prevent Age Resort "Pervaya Liniya" at 1 site in Russia.
Trial summary
To prove the effectiveness of complex wellness programs in terms of maintaining active longevity, including motivational counseling, high-intensity training, intermittent fasting, hypoxic training, as well as practices for achieving healthy sleep and mental well-being. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Healthy Lifestyle, Healthy Diet
- What is being tested?
- 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women over 18;
- No significant (affecting the functional state) "active" diseases: acute diseases and exacerbations of chronic diseases;
- Interest in active longevity and willingness to participate in research.
- Signed informed consent.
Who cannot join
- Age up to 18 years;
- Severe or moderate comorbidities;
- Rheumatological (systemic / autoimmune) diseases of any severity;
- Intestinal infections (within 3 months);
- SARS / pneumonia, other diseases accompanied by systemic inflammation during the last 2 months;
- Chronic inflammatory bowel disease;
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- Major surgery within the last 3 months
- Intoxication (alcohol, drugs, other toxins);
- Oncological disease (except for basalioma) out of remission;
- Persons with mental illness;
- Diabetes;
- Syndrome of obstructive sleep apnea of moderate and severe severity;
- Low adherence to lifestyle interventions, including physical activity of less than 150 minutes of aerobic activity per week (at least two days per week) or 75 minutes of vigorous exercise (at least 3 days per week).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
First Line Health Care Resort
Saint Petersburg
Anna Ratnikova, +7 921 303-15-33, a.ratnikova@hcresort.ru
About this study
To prove the effectiveness of complex wellness programs in terms of maintaining active longevity, including motivational counseling, high-intensity training, intermittent fasting, hypoxic training, as well as practices for achieving healthy sleep and mental well-being.
Clinical-instrumental, single-centre, prospective, open-label, non-randomized, sequential enrollment study with blinded endpoint analysis
- Conditions
- Healthy Aging, Healthy Lifestyle, Healthy Diet
- Being tested
- 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvementOther
- Nutrition: intermittent fasting;
- Physical activity: medium-intensity or high-intensity physical activity;
- Hypoxic training (at least three per visit to the center);
- correction of hygiene and sleep duration, relaxation techniques, cognitive behavioral therapy for insomnia.
- Individual motivational counseling.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | 1. Nutrition: intermittent fasting;
2. Physical activity: medium-intensity or high-intensity physical activity;
3. Hypoxic training (at least three per visit to the center);
4. correction of hygiene and sleep duration, relaxation techniques, cognitive behavioral therapy for insomnia.
5. Individual motivational counseling. Receives: Other: 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved endothelial function
improvement of flow-mediated vasodilatation measured by ultrasound (cuff test)
Measured: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
improved quality of night sleep
improvement in nighttime sleep quality assessed by a Pittsburgh Sleep Quality Scale
Measured: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Reducing the degree of anxiety
Reduction in the degree of anxiety according to the assessment of the Spielberger test
Measured: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Secondary outcomes (2)
increased self-esteem
increasing the level of self-esteem based on the results of the analysis of the Dembo-Rubinstein questionnaire
Measured: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
improved quality of night sleep
improvement in nighttime sleep quality assessed by a sleep indicator scale
Measured: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study startFeb 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prevent Age Resort "Pervaya Liniya"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Ratnikova, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361343
- Sponsor's protocol ID
- FLIPS-1
- Acronym
- FLIPS
- Status last verified
- Nov 2024
- First submitted
- 15 Apr 2022
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Prevent Age Study
- ClinicalTrials.gov ID
- NCT05361343
- Acronym / sponsor ID
- FLIPS / FLIPS-1
- Conditions
- Healthy Aging, Healthy Lifestyle, Healthy Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prevent Age Resort "Pervaya Liniya"University, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 May 2022 (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.
To prove the effectiveness of complex wellness programs in terms of maintaining active longevity, including motivational counseling, high-intensity training, intermittent fasting, hypoxic training, as well as practices for achieving healthy sleep and mental well-being.
Clinical-instrumental, single-centre, prospective, open-label, non-randomized, sequential enrollment study with blinded endpoint analysis
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement1. Nutrition: intermittent fasting; 2. Physical activity: medium-intensity or high-intensity physical activity; 3. Hypoxic training (at least three per visit to the center); 4. correction of hygiene and sleep duration, relaxation techniques, cognitive behavioral therapy for insomnia. 5. Individual motivational counseling. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18;
- No significant (affecting the functional state) "active" diseases: acute diseases and exacerbations of chronic diseases;
- Interest in active longevity and willingness to participate in research.
- Signed informed consent.
Key exclusion criteria (13 listed)
- Age up to 18 years;
- Severe or moderate comorbidities;
- Rheumatological (systemic / autoimmune) diseases of any severity;
- Intestinal infections (within 3 months);
- SARS / pneumonia, other diseases accompanied by systemic inflammation during the last 2 months;
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 |
|---|---|---|
| 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement1. Nutrition: intermittent fasting; 2. Physical activity: medium-intensity or high-intensity physical activity; 3. Hypoxic training (at least three per visit to the center); 4. correction of hygiene and sleep duration, relaxation techniques, cognitive behavioral therapy for insomnia. 5. Individual motivational counseling. | Other | Arm 1 |
Primary outcome
improved endothelial function
Time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
improvement of flow-mediated vasodilatation measured by ultrasound (cuff test)
improved quality of night sleep
Time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
improvement in nighttime sleep quality assessed by a Pittsburgh Sleep Quality Scale
Reducing the degree of anxiety
Time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Reduction in the degree of anxiety according to the assessment of the Spielberger test
2 secondary outcomes
increased self-esteem
Time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
improved quality of night sleep
Time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement in people with Healthy Aging and Healthy Lifestyle, run by Prevent Age Resort "Pervaya Liniya" at 1 site in Russia.
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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Ratnikova (+7 921 303-15-33, ya.ashikhmin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved endothelial function (time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)). The study lists 3 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 7 Nov 2024.