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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
2 capsules per day at breakfast with glass of water for 6 months.
2 capsules per day at breakfast with glass of water for 6 months.
2 capsules per day at breakfast with glass of water for 6 months.
University pf Primorska, Faculty of Health Sciences
Izola, Slovenia
RECRUITINGAlbumin
Albumin levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Creatinine
Creatinine levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Glucose
Glucose levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
CRP
CRP levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Lymphocyte percent
Lymphocyte percent will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Mean cell volume
Mean cell volume will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Red cell distribution width
Red cell distribution width will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Alcaline phosphatase
Alcaline phosphatase will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
White blood cell count
White blood cell count will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
PhenoAge
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 (according to Ruan et al, 2023).
Time frame: From enrolment to the end of last measurement at 6 months.
DNA methylation
DNA methylation will be measured from saliva at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Horvath epigenetic age
Horvath epigenetic age will be determined from saliva DNA methylation data (according to Horvath \& Raj, 2018) at baseline and 6 months of daily dietary supplements use..
Time frame: From enrolment to the end of last measurement at 6 months.
Total cholesterol
Total cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
LDL cholestorol
LDL cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
HDL cholesterol
HDL cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Triacylglycerols
Triacylglycerols levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Antioxidant potential
Antioxidant potential will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Aspartate aminotransferase (AST)
AST will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Alanine aminotransferase (ALT)
ALT will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Interleukine-6 (IL-6)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IL-6 will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Tumor necrosis factor alpha (TNF-alpha)
TNF-alpha will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
NAD+/NADH
NAD+/NADH ratio will be measured from venous blood at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Sleep quality
Sleep quality will be assessed with The Pittsburgh Sleep Quality Index (PSQI) 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.
Time frame: From enrolment to the end of last measurement at 6 months.
World Health Organization-FIve Well-Being Index
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
Time frame: From enrolment to the end of last measurement at 6 months.
BMAL1 gene expression
BMAL1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
ATG1 gene expression
ATG1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
SD1 gene expression
SD1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
mTOR gene expression
mTOR gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
SIRT1 gene expression
SIRT1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.
Glutation reductase gene expression
Glutation reductase gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.
Time frame: From enrolment to the end of last measurement at 6 months.