Sex-Speciffic Longevity Food Supplements

NCT07404449 | Active Not Recruiting Phase 1

• 1 other identifier: DOLGOZIVOST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aging

Keywords

biological age; food supplement; longevity

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (18)

• Total cholesterol

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

• LDL cholestorol

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

• HDL cholesterol

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

• Triacylglycerols

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

• Antioxidant potential

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

Other Outcomes (14)

• Body mass

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

• Blood pressure

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

• Physical activity level

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

Study Arms (4)

Female longevity food supplement

EXPERIMENTAL

6-month daily consumption of 2 capsules of female food supplement in the morning.

Dietary Supplement: compound food supplements - female specific

Female placebo

PLACEBO COMPARATOR

6-month daily consumption of 2 capsules of maltodextrin in the morning.

Dietary Supplement: Placebo

Male longevity food supplement

EXPERIMENTAL

6-month daily consumption of 2 capsules of male food supplement in the morning.

Dietary Supplement: compound food supplements - male specific

Male placebo

PLACEBO COMPARATOR

6-month daily consumption of 2 capsules of maltodextrin in the morning.

Dietary Supplement: Placebo

Interventions

compound food supplements - female specific DIETARY_SUPPLEMENT

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

Female longevity food supplement

compound food supplements - male specific DIETARY_SUPPLEMENT

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

Male longevity food supplement

Placebo DIETARY_SUPPLEMENT

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

Female placebo; Male placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Primorska: lead
• Biostile d.o.o.: collaborator

Study Sites (1)

University pf Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Related Publications (5)

• 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.

  PMID: 15380917 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 24138928 BACKGROUND

• 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.

  PMID: 29643443 BACKGROUND

• 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.

  PMID: 37918922 BACKGROUND

Related Links

• WHO5 Slovenian translation

Study Officials

• Ana Petelin, PhD

  University of Primorska, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind intervention study.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)