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Completed

NCT Number: NCT05399966

Effects of Monarda Didyma Extract Supplementation on Biological Ageing

This research aims to explore the potential benefits of supplementation of a natural ingredient, the Monarda didyma extract, to reduce / delay the biological aging of a susceptible population, thus contributing to two relevant topics in science with important social and economic implications: anti-aging strategies for wellness and healthy aging and environmental sustainability using natural products.

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Key information

Conditions

Aging

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedale Università Padova

Padova, PD, 35128, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
  • Age: 45 - 65

Exclusion criteria

  • Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular disease (e.g., stroke, heart attack))
  • Chronic intake of medication/dietary supplements with impact on stress levels (psychologically and physiological)
  • Consumption of any dietary/nutritional supplements or functional foods
  • Smokers
  • High caffeine intake > 5 coffee cups / day
  • Gastrointestinal diseases/conditions (ulcerative colitis, Crohn's disease, peptic ulcers, celiac disease)
  • Drug-, alcohol- and medication abuses
  • Known HIV-infection
  • Known acute or chronic hepatitis B and C infection
  • Known allergies against the mint family (labiate), especially lemon balm (la cedrella, la melissa, la citronella)
  • Pregnancy, breastfeeding or intention to become pregnant during the study
  • Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
  • Blood donation within 4 weeks prior to study start (screening) or during the study
  • Anticipating any planned changes in lifestyle for the duration of the study
  • Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol

Treatment and study plan

Monarda Didyma extract

Dietary Supplement

Monarda Didyma extract; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Placebo

Dietary Supplement

Maltodextrin; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Primary outcomes

  1. DNA methylation age (DNAmAge)

    Time frame: 12 weeks

    DNA methylation age (years)

  2. Age acceleration (AgeAcc)

    Time frame: 12 weeks

    Age acceleration as difference between DNA methylation age and chronological age (years)

  3. Leukocyte telomere length (LTL)

    Time frame: 12 weeks

    Leukocyte telomere length as ratio (T/S) of number telomere repeat sequences (T) to single-copy gene (S)

  4. Mitochondrial DNA copy number (mtDNAcn)

    Time frame: 12 weeks

    Mitochondrial DNA copy number (mtDNAcn) as ratio (MT/S) of mitochondrial DNA copy number (MT) and the singular copy number of a gene (S)

Secondary outcomes

  1. Telomerase expression (∆∆Ct)

    Time frame: 12 weeks

    Telomerase expression as comparative cycle threshold method (∆∆Ct), which compares the difference in cycle threshold values between groups.

  2. Blood pressure

    Time frame: 12 weeks

    Blood pressure as systolic blood and diastolic blood pressure (mm Hg)

  3. Salivary cortisol

    Time frame: 12 weeks

    Salivary cortisol (nmol/L).

  4. Leukocytes

    Time frame: 12 weeks

    Leukocytes (10^9/L)

  5. erythrocytes

    Time frame: 12 weeks

    erythrocytes (10^12/L)

  6. hemoglobin

    Time frame: 12 weeks

    hemoglobin (g/L)

  7. hematocrit

    Time frame: 12 weeks

    hematocrit (L/L)

  8. MCV mean corpuscular volume

    Time frame: 12 weeks

    MCV (fL)

  9. MCH mean corpuscular hemoglobin

    Time frame: 12 weeks

    MCH (pg)

  10. MCHC mean corpuscular hemoglobin concentration

    Time frame: 12 weeks

    MCHC (g/L)

  11. platelets

    Time frame: 12 weeks

    platelets (10^9/L)

  12. C reactive protein

    Time frame: 12 weeks

    C reactive protein - CRP (mg/L)

  13. interleukin 6

    Time frame: 12 weeks

    interleukin 6 - IL6 (ng/L)

  14. Questionnaire about Quality of Life: World Health Organization's Quality of Life Assessment BREF version (WHOQOL-BREF)

    Time frame: 12 weeks

    Domain scores for the WHOQOL-BREF are calculated by taking the mean of all items included in each domain and multiplying by a factor of four. These scores are then transformed to a 0-100 scale, where 100 is the highest and 0 is the lowest QoL.

  15. Questionnaire about sleeping patterns: Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 weeks

    The PSQI contains 19 self-reported combined to form seven "component" scores, each of which has a range of 0 (no difficulty) to 3 (severe difficulty) points. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

  16. Tracking of Hearth Rate using Miband 6 watch

    Time frame: 12 weeks

    hearth rate as beats per minute (BPM)

  17. Tracking of sleep using Miband 6 watch

    Time frame: 12 weeks

    sleep (hours)

  18. Tracking of mobility using Miband 6 watch

    Time frame: 12 weeks

    mobility (step counts)

  19. Total cholesterol

    Time frame: 12 weeks

    Total cholesterol (mg/dl)

  20. LDL

    Time frame: 12 weeks

    LDL (mg/dl)

  21. HDL

    Time frame: 12 weeks

    HDL (mg/dl)

  22. Triglycerides

    Time frame: 12 weeks

    Triglycerides (mg/dl)

  23. Glycemia

    Time frame: 12 weeks

    Glycemia (mg/dl)

  24. Insulin

    Time frame: 12 weeks

    Insulin (mcU/ml)

  25. HOMA

    Time frame: 12 weeks

    HOMA index - homeostasis model assessment

  26. AST

    Time frame: 12 weeks

    AST (IU/l) aspartate aminotransferase

  27. SGPT

    Time frame: 12 weeks

    SGPT (IU/l) Serum Glutamic Pyruvic Transaminase

  28. GGT

    Time frame: 12 weeks

    GGT (U/l) gamma glutamyl transferase

  29. Creatinine

    Time frame: 12 weeks

    Creatinine (mg/dl)

  30. Waist

    Time frame: 12 weeks

    Waist circumference (cm)

  31. Weight

    Time frame: 12 weeks

    Weight (kg)

  32. Total cholesterol/HDL

    Time frame: 12 weeks

    Total cholesterol/HDL

  33. LDL/HDL

    Time frame: 12 weeks

    LDL/HDL cholesterol ratio

Sponsors and collaborators

Lead sponsor

Sofia Pavanello

Other

Collaborators

  • Mibelle AG

Registry information

Official study title

Investigating the Effects of Monarda Didyma Extract Supplementation on Biological Aging of Susceptible Population: a Randomized, Placebo Controlled, Double Blind Parallel Study

Acronym: EMODISU

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 1, 2022
Registry last updated
Jun 6, 2024

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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