First Line Prevent Age Study (FLIPS)

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 Overview

• Status: Recruiting
• Conditions: Healthy Aging; Healthy Diet; Healthy Lifestyle
• Intervention / Treatment: Other: 1. Nutrition; 2. Physical activity; 3. Hypoxic training; 4. Menthal heals improvement

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Ratnikova; Phone Number: +7 921 303-15-33; Email: ya.ashikhmin@gmail.com

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Recruiting
    • First Line Health Care Resort
    • Contact: Anna Ratnikova; Phone Number: +7 921 303-15-33; Email: a.ratnikova@hcresort.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Arm 1; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improved endothelial function	improvement of flow-mediated vasodilatation measured by ultrasound (cuff test)	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	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	First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increased self-esteem	increasing the level of self-esteem based on the results of the analysis of the Dembo-Rubinstein questionnaire	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	First point: 1 week (2nd visit). Second oint after 6 - 13 months (3rd visit)

Collaborators and Investigators

• Sponsor: Prevent Age Resort "Pervaya Liniya"

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FLIPS-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No