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AgingEMODISUNCT05399966

Effects of Monarda Didyma Extract Supplementation on Biological Ageing

A study testing Monarda Didyma extract in people with Aging, run by Sofia Pavanello at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Monarda Didyma extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteItaly
Study dates
28 Feb 2023to 30 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

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 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedale Università Padova

    Padova, PD, 35128

Other trials in Italy

About this study

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

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.

Conditions
Aging
Being tested
Monarda Didyma extract, Placebo

What participants receive

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

  • Monarda Didyma extractDietary supplement

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

  • PlaceboDietary supplement

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

Study groups in NCT05399966
Study groupRoleWhat they receive
Monarda Didyma extractExperimentalMonarda Didyma extract
Receives: Dietary Supplement: Monarda Didyma extract
PlaceboPlacebo comparatorMaltodextrin
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. DNA methylation age (DNAmAge)

    DNA methylation age (years)

    Measured: 12 weeks

  2. Age acceleration (AgeAcc)

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

    Measured: 12 weeks

  3. Leukocyte telomere length (LTL)

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

    Measured: 12 weeks

  4. Mitochondrial DNA copy number (mtDNAcn)

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

    Measured: 12 weeks

Secondary outcomes (33)

  1. Telomerase expression (∆∆Ct)

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

    Measured: 12 weeks

  2. Blood pressure

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

    Measured: 12 weeks

  3. Salivary cortisol

    Salivary cortisol (nmol/L).

    Measured: 12 weeks

  4. Leukocytes

    Leukocytes (10^9/L)

    Measured: 12 weeks

  5. erythrocytes

    erythrocytes (10^12/L)

    Measured: 12 weeks

  6. hemoglobin

    hemoglobin (g/L)

    Measured: 12 weeks

  7. hematocrit

    hematocrit (L/L)

    Measured: 12 weeks

  8. MCV mean corpuscular volume

    MCV (fL)

    Measured: 12 weeks

  9. MCH mean corpuscular hemoglobin

    MCH (pg)

    Measured: 12 weeks

  10. MCHC mean corpuscular hemoglobin concentration

    MCHC (g/L)

    Measured: 12 weeks

  11. platelets

    platelets (10^9/L)

    Measured: 12 weeks

  12. C reactive protein

    C reactive protein - CRP (mg/L)

    Measured: 12 weeks

  13. interleukin 6

    interleukin 6 - IL6 (ng/L)

    Measured: 12 weeks

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

    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.

    Measured: 12 weeks

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

    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.

    Measured: 12 weeks

  16. Tracking of Hearth Rate using Miband 6 watch

    hearth rate as beats per minute (BPM)

    Measured: 12 weeks

  17. Tracking of sleep using Miband 6 watch

    sleep (hours)

    Measured: 12 weeks

  18. Tracking of mobility using Miband 6 watch

    mobility (step counts)

    Measured: 12 weeks

  19. Total cholesterol

    Total cholesterol (mg/dl)

    Measured: 12 weeks

  20. LDL

    LDL (mg/dl)

    Measured: 12 weeks

  21. HDL

    HDL (mg/dl)

    Measured: 12 weeks

  22. Triglycerides

    Triglycerides (mg/dl)

    Measured: 12 weeks

  23. Glycemia

    Glycemia (mg/dl)

    Measured: 12 weeks

  24. Insulin

    Insulin (mcU/ml)

    Measured: 12 weeks

  25. HOMA

    HOMA index - homeostasis model assessment

    Measured: 12 weeks

  26. AST

    AST (IU/l) aspartate aminotransferase

    Measured: 12 weeks

  27. SGPT

    SGPT (IU/l) Serum Glutamic Pyruvic Transaminase

    Measured: 12 weeks

  28. GGT

    GGT (U/l) gamma glutamyl transferase

    Measured: 12 weeks

  29. Creatinine

    Creatinine (mg/dl)

    Measured: 12 weeks

  30. Waist

    Waist circumference (cm)

    Measured: 12 weeks

  31. Weight

    Weight (kg)

    Measured: 12 weeks

  32. Total cholesterol/HDL

    Total cholesterol/HDL

    Measured: 12 weeks

  33. LDL/HDL

    LDL/HDL cholesterol ratio

    Measured: 12 weeks

Timeline

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

  1. First posted1 Jun 2022
  2. Study start28 Feb 2023
  3. Primary completion30 Sep 2023
  4. Study completion30 Jan 2024

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot study; randomized, placebo-controlled, double-blind, parallel design, monocentric.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05399966
Sponsor's protocol ID
BIOAGELAB202201
Acronym
EMODISU
Status last verified
Jun 2024
First submitted
17 May 2022
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yao Q, Lin MT, Zhu YD, Xu HL, Zhao YZ. Recent Trends in Potential Therapeutic Applications of the Dietary Flavonoid Didymin. Molecules. 2018 Oct 6;23(10):2547. doi: 10.3390/molecules23102547.

    PubMed 30301216

  • Feng Z, Pang L, Chen S, Pang X, Huang Y, Qiao Q, Wang Y, Vonglorkham S, Huang Q, Lin X, Wei J. Didymin ameliorates dexamethasone-induced non-alcoholic fatty liver disease by inhibiting TLR4/NF-kappaB and PI3K/Akt pathways in C57BL/6J mice. Int Immunopharmacol. 2020 Nov;88:107003. doi: 10.1016/j.intimp.2020.107003. Epub 2020 Sep 23.

    PubMed 33182043

  • Lin X, Bai F, Nie J, Lu S, Lu C, Zhu X, Wei J, Lu Z, Huang Q. Didymin Alleviates Hepatic Fibrosis Through Inhibiting ERK and PI3K/Akt Pathways via Regulation of Raf Kinase Inhibitor Protein. Cell Physiol Biochem. 2016;40(6):1422-1432. doi: 10.1159/000453194. Epub 2016 Dec 20.

    PubMed 27997902

  • Pavanello S, Campisi M, Tona F, Lin CD, Iliceto S. Exploring Epigenetic Age in Response to Intensive Relaxing Training: A Pilot Study to Slow Down Biological Age. Int J Environ Res Public Health. 2019 Aug 23;16(17):3074. doi: 10.3390/ijerph16173074.

    PubMed 31450859

  • Campisi M, Liviero F, Maestrelli P, Guarnieri G, Pavanello S. DNA Methylation-Based Age Prediction and Telomere Length Reveal an Accelerated Aging in Induced Sputum Cells Compared to Blood Leukocytes: A Pilot Study in COPD Patients. Front Med (Lausanne). 2021 Jul 23;8:690312. doi: 10.3389/fmed.2021.690312. eCollection 2021.

    PubMed 34368190

  • Pavanello S, Campisi M, Fabozzo A, Cibin G, Tarzia V, Toscano G, Gerosa G. The biological age of the heart is consistently younger than chronological age. Sci Rep. 2020 Jul 1;10(1):10752. doi: 10.1038/s41598-020-67622-1.

    PubMed 32612244

  • Pavanello S, Dioni L, Hoxha M, Fedeli U, Mielzynska-Svach D, Baccarelli AA. Mitochondrial DNA copy number and exposure to polycyclic aromatic hydrocarbons. Cancer Epidemiol Biomarkers Prev. 2013 Oct;22(10):1722-9. doi: 10.1158/1055-9965.EPI-13-0118. Epub 2013 Jul 24.

    PubMed 23885040

Questions about this trial

What is this clinical trial studying?

A study testing Monarda Didyma extract in people with Aging, run by Sofia Pavanello at 1 site in Italy.

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 2 inclusion and 15 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: finished, as of the sponsor's last update on 6 Jun 2024. 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 Italy. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

DNA methylation age (DNAmAge) (time frame: 12 weeks). The study lists 4 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 NCT05399966, which also lists 7 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 6 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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