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Active, Not Recruiting

NCT Number: NCT07416396

Morning-Evening Specific Longevity Food Supplement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University pf Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Morning- and evening-specific compound food supplement

Dietary 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.

Control

Dietary Supplement

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

Primary outcomes

  1. Creatinine

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

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

  2. Albumin

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

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

  3. Glucose

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

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

  4. CRP

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

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

  5. Lymphocyte percent

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

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

  6. Mean cell volume

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

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

  7. Red cell distribution width

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

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

  8. Alcaline phosphatase

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

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

  9. White blood cell count

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

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

  10. PhenoAge

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

    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.

Secondary outcomes

  1. Total cholesterol

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

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

  2. LDL cholesterol

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

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

  3. HDL cholesterol

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

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

  4. Triacylglycerols

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

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

  5. Antioxidative potential

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

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

  6. Alanine aminotransferase (ALT)

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

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

  7. Aspartate aminotransferase (AST)

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

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

  8. Interleukine-6 (IL-6)

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

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

  9. Tumor necrosis factor alpha (TNF-alpha)

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

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

  10. NAD+/NADH

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

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

  11. Sleep quality

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

    Sleep quality will be assessed with THe Pittsburgh Sleep Quality Index 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.

  12. World Health Organization-FIve Well-Being Index

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

    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.

  13. BMAL1 gene expression

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

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

  14. ATG1 gene expression

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

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

  15. SD1 gene expression

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

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

  16. mTOR gene expression

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

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

  17. SIRT1 gene expression

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

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

  18. Glutation reductase gene expression

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

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

Other outcomes

  1. Body mass

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

    Body mass [kg] will be measured with body scale at baseline, after 1, 3 and 6 months of daily dietary supplements use.

  2. Blood pressure

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

    Systolic and diastolic blood pressures [mmHg] will be measured at baseline, after 1, 3 and 6 months of daily dietary supplements use.

  3. Physical activity level

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

    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.

  4. Body height

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

    Body height [m] will be measured with stadiometer at baseline.

  5. Body mass index

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

    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.

  6. Bioimpedance analysis

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

    Resistance and reactance will be measured with Bioelectrical Impedance Analysis (BIA) at baseline, after 1, 3 and 6 months of daily dietary supplements use.

  7. Body fat percentage

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

    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.

  8. Fat free mass

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

    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.

  9. Phase angle

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

    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.

  10. Muscle mass

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

    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.

  11. Metabolic age

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

    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.

  12. Visceral fat rating

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

    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.

  13. Waist circumference

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

    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.

  14. Hip circumference

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

    Hip circumference (HC, [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.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • Biostile

Registry information

Official study title

Effects of Morning and Evening Specific Compound Food Supplements on Changes in Biomarkers Associated With Longevity

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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