Clinical trial NCT05399966: Effects of Monarda Didyma Extract Supplementation on Biological Ageing
Official title: Investigating the Effects of Monarda Didyma Extract Supplementation on Biological Aging of Susceptible Population: a Randomized, Placebo Controlled, Double Blind Parallel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Mibelle AG
First posted: 2022-06-01
Enrollment: 81
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study; randomized, placebo-controlled, double-blind, parallel design, monocentric.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: DNA methylation age (DNAmAge)
timeFrame: 12 weeks
measure: Age acceleration (AgeAcc)
timeFrame: 12 weeks
measure: Leukocyte telomere length (LTL)
timeFrame: 12 weeks
measure: Mitochondrial DNA copy number (mtDNAcn)
timeFrame: 12 weeks
Secondary outcomes:
measure: Telomerase expression (∆∆Ct)
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Salivary cortisol
timeFrame: 12 weeks
measure: Leukocytes
timeFrame: 12 weeks
measure: erythrocytes
timeFrame: 12 weeks
measure: hemoglobin
timeFrame: 12 weeks
measure: hematocrit
timeFrame: 12 weeks
measure: MCV mean corpuscular volume
timeFrame: 12 weeks
measure: MCH mean corpuscular hemoglobin
timeFrame: 12 weeks
measure: MCHC mean corpuscular hemoglobin concentration
timeFrame: 12 weeks
measure: platelets
timeFrame: 12 weeks
measure: C reactive protein
timeFrame: 12 weeks
measure: interleukin 6
timeFrame: 12 weeks
measure: Questionnaire about Quality of Life: World Health Organization's Quality of Life Assessment BREF version (WHOQOL-BREF)
timeFrame: 12 weeks
measure: Questionnaire about sleeping patterns: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 weeks
measure: Tracking of Hearth Rate using Miband 6 watch
timeFrame: 12 weeks
measure: Tracking of sleep using Miband 6 watch
timeFrame: 12 weeks
measure: Tracking of mobility using Miband 6 watch
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: LDL
timeFrame: 12 weeks
measure: HDL
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: Glycemia
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: HOMA
timeFrame: 12 weeks
measure: AST
timeFrame: 12 weeks
measure: SGPT
timeFrame: 12 weeks
measure: GGT
timeFrame: 12 weeks
measure: Creatinine
timeFrame: 12 weeks
measure: Waist
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Total cholesterol/HDL
timeFrame: 12 weeks
measure: LDL/HDL
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
state: PD
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.