Sex-Speciffic Longevity Food Supplements

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

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 Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: compound food supplements - female specific; Dietary supplement: Placebo; Dietary supplement: compound food supplements - male specific

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Slovenia
  • Izola, Slovenia, 6310
    • University pf Primorska, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Female longevity food supplement; 6-month daily consumption of 2 capsules of female food supplement in the morning.	Dietary supplement: compound food supplements - female specific; 2 capsules per day at breakfast with glass of water for 6 months.
Placebo Comparator: Female placebo; 6-month daily consumption of 2 capsules of maltodextrin in the morning.	Dietary supplement: Placebo; 2 capsules per day at breakfast with glass of water for 6 months.
Experimental: Male longevity food supplement; 6-month daily consumption of 2 capsules of male food supplement in the morning.	Dietary supplement: compound food supplements - male specific; 2 capsules per day at breakfast with glass of water for 6 months.
Placebo Comparator: Male placebo; 6-month daily consumption of 2 capsules of maltodextrin in the morning.	Dietary supplement: Placebo; 2 capsules per day at breakfast with glass of water for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin	Albumin levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	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..	From enrolment to the end of last measurement at 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol	Total cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.	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.	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.	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.	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.	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.	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.	From enrolment to the end of last measurement at 6 months.
Interleukine-6 (IL-6)	IL-6 will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	From enrolment to the end of last measurement at 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Body mass [kg] will be measured with body scale at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Blood pressure	Systolic and diastolic blood pressures [mmHg} will be measured at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Physical activity level	Physical activity level will be assessed with International Physical Activity Questionnaire (IPAQ) at baseline, after 1, 3 and 6 months of daily dietary supplements use. IPAQ quantifies physical activity into MET-minutes/week (walking=3.3, moderate=4.0, vigorous=8.0 METs). High activity is more than 3000 MET-min/week, Moderate is between 600 MET-min/week and 3000 MET-min/week, and Low is less than 600 MET-min/week.	From enrolment to the end of last measurement at 6 months.
Body height	Body height [m] will be measured with stadiometer at baseline.	From enrolment to the end of the first measurement.
Body mass index	Body mass index (BMI, [kg/m2]) will be calculated from body mass (BM, [kg]) and body height (BH, [m]) using the standard equation BMI = BM/(BH x BH) at baseline, after 1, 3 and 6 months of daily dietary supplements use. BH data measured at baseline will be used throughout the study while BM will be measured at each measurement as specified.	From enrolment to the end of last measurement at 6 months.
Bioimpedance analysis	Resistance and reactance will be measured with Bioelectrical Impedance Analysis (BIA) at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Body fat percentage	Body fat percentage will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Fat free mass	Fat free mass will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Phase angle	Phase angle will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Muscle mass	Muscle mass will be calculated from resistance and reactance data, determined with BIA at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Metabolic age	Metabolic age will be calculated from resistance and reactance data with BIA software at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Visceral fat rating	Visceral fat rating will be calculated from resistance and reactance datawith BIA software at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Waist circumference	Waist circumference (WC, [cm]) will be measured with measuring tape half way between the lowest rib and top of the hip bone at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.
Hip circumference	Hip circumference (HC, [cm]) will be measured with measuring tape around the widest part of the buttocks at baseline, after 1, 3 and 6 months of daily dietary supplements use.	From enrolment to the end of last measurement at 6 months.

Collaborators and Investigators

• Sponsor: University of Primorska
• Collaborators: Biostile d.o.o.
• Investigators: Principal Investigator: Ana Petelin, PhD, University of Primorska, Faculty of Health Sciences

Publications and helpful links

General Publications

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
• Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.
• Horvath S. DNA methylation age of human tissues and cell types. Genome Biol. 2013;14(10):R115. doi: 10.1186/gb-2013-14-10-r115.
• Horvath S, Raj K. DNA methylation-based biomarkers and the epigenetic clock theory of ageing. Nat Rev Genet. 2018 Jun;19(6):371-384. doi: 10.1038/s41576-018-0004-3.
• Ruan Z, Li D, Huang D, Liang M, Xu Y, Qiu Z, Chen X. Relationship between an ageing measure and chronic obstructive pulmonary disease, lung function: a cross-sectional study of NHANES, 2007-2010. BMJ Open. 2023 Nov 2;13(11):e076746. doi: 10.1136/bmjopen-2023-076746.

Helpful Links

• WHO5 Slovenian translation

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: food supplement; longevity; biological age
• Other Study ID Numbers: DOLGOZIVOST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No