Aging
Conditions
Keywords
biological age, food supplement, longevity, sleep quality
Brief 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 present clinical trial will evaluate the effects of selected morning- and evening-speciffic dietary supplement on longevity biomarkers in a selected population of healthy adults of both sexes between the ages of 50 and 70 and compare it to placebo. The main questions it answers are: Does the 6-month use of the longevity supplement impact 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 morning- and evening-speciffic longevity food supplements and 30 will consume a placebo. The study will last 6 months. The subjects will 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, subjects 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, liver enzymes, and expression of genes for autophagy and oxidative stress. Subjects 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 and DXA body composition measurements will be performed.
Interventions
DIETARY_SUPPLEMENTMorning- and evening-specific compound food supplement
1 capsule of morning-speciffic supplement per day after breakfast with glass of water and 1 capsule of evening-speciffic supplement per day after dinner with glass of water for 6 months.
DIETARY_SUPPLEMENTControl
2 capsules per day at breakfast with glass of water for 6 months.
Sponsors
University of Primorska
Biostile d.o.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
1. Acute and chronic diseases (cardiovascular diseases, diabetes, neurodegenerative diseases, gastrointestinal diseases). 2. Patients with serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases. 3. BMI less than 22 kg/m2 and greater than 30 kg/m2. 4. Celiac disease or gluten intolerance. 5. Presence of implants, devices or other foreign materials in the measurement area. 6. Smoking. 7. Atypical sleep patterns. 8. Use of dietary supplements and medications. 9. Extreme physical activity. 10. Excessive alcohol consumption (more than one drink per day for women, more than two drinks per day for men).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine | From enrolment to the end of last measurement at 6 months. | Creatinine levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Albumin | From enrolment to the end of last measurement at 6 months. | Albumin levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Glucose | From enrolment to the end of last measurement at 6 months. | Glucose levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| CRP | From enrolment to the end of last measurement at 6 months. | CRP levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Lymphocyte percent | From enrolment to the end of last measurement at 6 months. | Lymphocyte percent will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Mean cell volume | From enrolment to the end of last measurement at 6 months. | Mean cell volume will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Red cell distribution width | From enrolment to the end of last measurement at 6 months. | Red cell distribution width will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Alcaline phosphatase | From enrolment to the end of last measurement at 6 months. | Alcaline phosphatase will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| White blood cell count | From enrolment to the end of last measurement at 6 months. | White blood cell count will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| PhenoAge | From enrolment to the end of last measurement at 6 months. | PhenoAge will be calculated from albumin, creatinine, glucose, lymphocyte percent, mean cell volume, red cell distribution width, alcaline phosphatase, white blood cell count and cronological age at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | From enrolment to the end of last measurement at 6 months. | Total cholesterol will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| LDL cholesterol | From enrolment to the end of last measurement at 6 months. | LDL cholesterol will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| HDL cholesterol | From enrolment to the end of last measurement at 6 months. | HDL cholesterol will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Triacylglycerols | From enrolment to the end of last measurement at 6 months. | Triacylglycerols levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Antioxidative potential | From enrolment to the end of last measurement at 6 months. | Antioxidative potential will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Alanine aminotransferase (ALT) | From enrolment to the end of last measurement at 6 months. | ALT will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Aspartate aminotransferase (AST) | From enrolment to the end of last measurement at 6 months. | AST will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Interleukine-6 (IL-6) | From enrolment to the end of last measurement at 6 months. | IL-6 will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| Tumor necrosis factor alpha (TNF-alpha) | From enrolment to the end of last measurement at 6 months. | TNF-alpha will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use. |
| NAD+/NADH | From enrolment to the end of last measurement at 6 months. | NAD+/NADH ratio will be measured from venous blood at baseline and 6 months of daily dietary supplements use. |
| Sleep quality | From enrolment to the end of last measurement at 6 months. | Sleep quality will be assessed with THe Pittsburgh Sleep Quality Index questionnaire (Buysse et al., 1989) at baseline, after 1, 3 and 6 months of daily dietary supplements use. PSQI is a self-report questionnaire that evaluates sleep quality over the past month, using 19 items to generate 7 component scores (0-3 each) and a global score (0-21). A total global score \>5 indicates poor sleep quality. Higher scores signify more severe sleep disturbances. |
| World Health Organization-FIve Well-Being Index | From enrolment to the end of last measurement at 6 months. | Quality of life will be assessed with World Health Organization-FIve Well-Being Index (WHO5 questionnaire, Slovenian translation, WHO, 2024) at baseline, after 1, 3 and 6 months of daily dietary supplements use. The WHO-5 Well-Being Index is a 5-item self-report questionnaire measuring mental well-being over the past two weeks, scored on a 0-25 scale that is multiplied by 4 for a 0-100 range. Higher scores indicate better well-being, while a score 50 or less suggests poor well-being. |
| BMAL1 gene expression | From enrolment to the end of last measurement at 6 months. | BMAL1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. |
| ATG1 gene expression | From enrolment to the end of last measurement at 6 months. | ATG1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. |
| SD1 gene expression | From enrolment to the end of last measurement at 6 months. | SD1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. |
| mTOR gene expression | From enrolment to the end of last measurement at 6 months. | mTOR gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. |
| SIRT1 gene expression | From enrolment to the end of last measurement at 6 months. | SIRT1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. |
| Glutation reductase gene expression | From enrolment to the end of last measurement at 6 months. | Glutation reductase gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use. |
Countries
Slovenia
Outcome results
None listed