Effects of Monarda Didyma Extract Supplementation on Biological Ageing

NCT05399966 | Completed

• 1 other identifier: BIOAGELAB202201
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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 wellness and healthy aging and environmental sustainability using natural products.

Conditions

Aging

Outcome Measures

Primary Outcomes (4)

• DNA methylation age (DNAmAge)

  DNA methylation age (years)

  12 weeks

• Age acceleration (AgeAcc)

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

  12 weeks

• Leukocyte telomere length (LTL)

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

  12 weeks

• 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)

  12 weeks

Secondary Outcomes (33)

• Telomerase expression (∆∆Ct)

  12 weeks

• Blood pressure

  12 weeks

• Salivary cortisol

  12 weeks

• Leukocytes

  12 weeks

• erythrocytes

  12 weeks

Study Arms (2)

Monarda Didyma extract

EXPERIMENTAL

Monarda Didyma extract

Dietary Supplement: Monarda Didyma extract

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Monarda Didyma extract DIETARY_SUPPLEMENT

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

Monarda Didyma extract

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sofia Pavanello: lead
• Mibelle AG: collaborator

Study Sites (1)

Azienda Ospedale Università Padova

Padua, PD, 35128, Italy

Location

Related Publications (7)

• 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.

  PMID: 30301216 BACKGROUND

• 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.

  PMID: 33182043 BACKGROUND

• 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.

  PMID: 27997902 BACKGROUND

• 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.

  PMID: 31450859 BACKGROUND

• 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.

  PMID: 34368190 BACKGROUND

• 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.

  PMID: 32612244 BACKGROUND

• 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.

  PMID: 23885040 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor

Model Details: Pilot study; randomized, placebo-controlled, double-blind, parallel design, monocentric.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 1, 2022
• Study Start: February 28, 2023
• Primary Completion: September 30, 2023
• Study Completion: January 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)