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AzTrials

AgingPhase 1NCT07404449

Sex-Speciffic Longevity Food Supplements

A Phase 1 study testing compound food supplements - female specific and compound food supplements - male specific in people with Aging, run by University of Primorska at 1 site in Slovenia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
compound food supplements - female specific and compound food supplements - male specific
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteSlovenia
Study dates
7 Mar 2026to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Slovenia1 site
  • University pf Primorska, Faculty of Health Sciences

    Izola, 6310

Other trials in Slovenia

About this study

Official title: 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:

Read more

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
Aging
Being tested
compound food supplements - female specific, compound food supplements - male specific, Placebo
Keywords
biological age, food supplement, longevity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • compound food supplements - female specificDietary supplement

    2 capsules per day at breakfast with glass of water for 6 months.

  • compound food supplements - male specificDietary supplement

    2 capsules per day at breakfast with glass of water for 6 months.

  • PlaceboDietary supplement

    2 capsules per day at breakfast with glass of water for 6 months.

Study groups in NCT07404449
Study groupRoleWhat they receive
Female longevity food supplementExperimental6-month daily consumption of 2 capsules of female food supplement in the morning.
Receives: Dietary Supplement: compound food supplements - female specific
Female placeboPlacebo comparator6-month daily consumption of 2 capsules of maltodextrin in the morning.
Receives: Dietary Supplement: Placebo
Male longevity food supplementExperimental6-month daily consumption of 2 capsules of male food supplement in the morning.
Receives: Dietary Supplement: compound food supplements - male specific
Male placeboPlacebo comparator6-month daily consumption of 2 capsules of maltodextrin in the morning.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Albumin

    Albumin levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  2. Creatinine

    Creatinine levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  3. Glucose

    Glucose levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  4. CRP

    CRP levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  5. Lymphocyte percent

    Lymphocyte percent will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  6. 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.

    Measured: From enrolment to the end of last measurement at 6 months.

  7. 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.

    Measured: From enrolment to the end of last measurement at 6 months.

  8. Alcaline phosphatase

    Alcaline phosphatase will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  9. 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.

    Measured: From enrolment to the end of last measurement at 6 months.

  10. 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).

    Measured: From enrolment to the end of last measurement at 6 months.

  11. DNA methylation

    DNA methylation will be measured from saliva at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  12. 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..

    Measured: From enrolment to the end of last measurement at 6 months.

Secondary outcomes (18)
  1. Total cholesterol

    Total cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  2. LDL cholestorol

    LDL cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  3. HDL cholesterol

    HDL cholesterol levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  4. Triacylglycerols

    Triacylglycerols levels will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  5. Antioxidant potential

    Antioxidant potential will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  6. Aspartate aminotransferase (AST)

    AST will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  7. Alanine aminotransferase (ALT)

    ALT will be measured from venous blood at baseline, after 1, 3 and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  8. 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.

    Measured: From enrolment to the end of last measurement at 6 months.

  9. 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.

    Measured: From enrolment to the end of last measurement at 6 months.

  10. NAD+/NADH

    NAD+/NADH ratio will be measured from venous blood at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  11. 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.

    Measured: From enrolment to the end of last measurement at 6 months.

  12. 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

    Measured: From enrolment to the end of last measurement at 6 months.

  13. BMAL1 gene expression

    BMAL1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  14. ATG1 gene expression

    ATG1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  15. SD1 gene expression

    SD1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  16. mTOR gene expression

    mTOR gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  17. SIRT1 gene expression

    SIRT1 gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

  18. Glutation reductase gene expression

    Glutation reductase gene expression will be determined from Lymphocyte fraction at baseline and 6 months of daily dietary supplements use.

    Measured: From enrolment to the end of last measurement at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start7 Mar 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind intervention study.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07404449
Sponsor's protocol ID
DOLGOZIVOST
Status last verified
Feb 2026
First submitted
4 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15380917
  • 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.

    PubMed 2748771
  • 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.

    PubMed 24138928
  • 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.

    PubMed 29643443
  • 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.

    PubMed 37918922

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing compound food supplements - female specific and compound food supplements - male specific in people with Aging, run by University of Primorska at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Albumin (time frame: From enrolment to the end of last measurement at 6 months.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07404449, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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