Overview
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.
Eligibility
Inclusion Criteria:
- Body mass index (BMI) between 22 kg/m2 and 30 kg/m2
- Postmenopausal women (at least 12 months without menstruation)
- Healthy individuals, without risk of chronic non-communicable diseases
- Signed written informed consent
Exclusion Criteria:
- Acute and chronic diseases (cardiovascular diseases, diabetes, neurodegenerative diseases, gastrointestinal diseases)
- Patients with serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases
- BMI less than 22 kg/m2 and greater than 30 kg/m2
- Celiac disease or gluten intolerance
- Presence of implants, devices or other foreign materials in the measurement area
- Smoking
- Atypical sleep patterns
- Use of dietary supplements and medications
- Extreme physical activity
- Excessive alcohol consumption (more than one drink per day for women, more than two drinks per day for men)