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Active Not RecruitingNCT07404449

Sex-Speciffic Longevity Food Supplements

Effects of Sex-Speciffic Compound Food Supplements on Changes in Biomarkers and Epigenetic Changes Associated With Longevity

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of Primorska · Academic / Other
Sex
All
Age
50 Years – 70 Years
Healthy volunteers
Accepted

Summary

The use of food supplements with the aim of increasing longevity in the general population is rapidly increasing, while high-quality clinical evidence on the efficacy of comprehensive formulations and their impact on biomarkers of aging is lacking. The investigators will perform a double-blind, placebo-controlled, randomized clinical trial of a selected sex-specific dietary supplement in relation to longevity in a selected population of healthy adults of both sexes between the ages of 50 and 70. The main questions the study answers are: Does the 6-month use of the longevity supplement impacts the 6-months change in different markers for measuring biological age compared to placebo? The study will involve 60 subjects, of whom 30 will consume the sex-specific longevity food supplements and 30 will consume a placebo. The study will last 6 months. The participants will visit the Faculty four times: at the beginning of the study (background measurement), after one, three and six months of consuming the dietary supplement or placebo. At each visit, the participants will undergo anthropometric measurements, blood pressure measurements, and blood samples will be taken to determine baseline haematocrite, albumin, creatinine, alcaline phosphatase, lipid profile, glucose concentration, inflammatory parameters, antioxidant potential, inflammatory markers, liver enzymes, and expression of genes for autophagy and oxidative stress. The participants will also complete 3-day food diaries and questionnaires on general health, physical activity, and quality of sleep and life. On baseline and final (six months) measurements resting metabolic rate, DXA body composition measurements will be performed and saliva samples will be obtained for DNA methilation determination.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTcompound food supplements - female specific2 capsules per day at breakfast with glass of water for 6 months.
DIETARY_SUPPLEMENTcompound food supplements - male specific2 capsules per day at breakfast with glass of water for 6 months.
DIETARY_SUPPLEMENTPlacebo2 capsules per day at breakfast with glass of water for 6 months.

Timeline

Start date
2026-03-07
Primary completion
2026-10-01
Completion
2027-03-01
First posted
2026-02-11
Last updated
2026-03-10

Locations

1 site across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT07404449. Inclusion in this directory is not an endorsement.