NCT07416396

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 7, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 11, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 9, 2026

Last Update Submit

March 8, 2026

Conditions

Aging

Keywords

biological agefood supplementlongevitysleep quality

Outcome Measures

Primary Outcomes (10)

  • 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.

  • 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.

  • 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.

    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 cholesterol

    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.

  • Antioxidative potential

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

  • +13 more secondary outcomes

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.

  • +11 more other outcomes

Study Arms (2)

Morning- and evening-speciffic longevity food supplement

EXPERIMENTAL

6-month daily consumption of 1 morning-specific capsule and 1 evening-specific capsule.

Dietary Supplement: Morning- and evening-specific compound food supplement

Control

PLACEBO COMPARATOR

6-month daily consumption of 2 capsules of maltodextrin.

Dietary Supplement: Control

Interventions

Morning- and evening-specific compound food supplementDIETARY_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.

Morning- and evening-speciffic longevity food supplement
ControlDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University pf Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Related Publications (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.

    PMID: 37918922BACKGROUND

  • 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: 2748771BACKGROUND

  • 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: 15380917BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 18, 2026

Study Start

March 7, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)