First Line Prevent Age Study

NCT05361343 | Recruiting DMC

• 1 other identifier: FLIPS-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. Clinical-instrumental, single-centre, prospective, open-label, non-randomized, sequential enrollment study with blinded endpoint analysis

Conditions

Healthy Aging; Healthy Lifestyle; Healthy Diet

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• increased self-esteem

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

• improved quality of night sleep

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

Study Arms (1)

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.

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

Interventions

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

Arm 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Prevent Age Resort "Pervaya Liniya": lead

Study Sites (1)

First Line Health Care Resort

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Central Study Contacts

Anna Ratnikova

CONTACT

+7 921 303-15-33; ya.ashikhmin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, MD, PhD, Chief physician, PervayaLiniyaResort, Russia

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 4, 2022
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

RU (1)