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NCT Number: NCT05361343

First Line Prevent Age 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

Recruiting

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Key information

Conditions

Healthy Aging Healthy Diet Healthy Lifestyle

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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).

Treatment and study plan

1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement

Other
  • 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.

Primary outcomes

  1. 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)

  2. 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

  3. 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

Secondary outcomes

  1. increased self-esteem

    Time frame: First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)

    increasing the level of self-esteem based on the results of the analysis of the Dembo-Rubinstein questionnaire

  2. 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 sleep indicator scale

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Ratnikova

CONTACT

[email protected]

+7 921 303-15-33

Sponsors and collaborators

Lead sponsor

Prevent Age Resort "Pervaya Liniya"

Other

Registry information

Acronym: FLIPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2022
Registry last updated
Nov 7, 2024

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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