Effects of Monarda Didyma Extract Supplementation on Biological Ageing

Aging Clinical Trial

— EMODISU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05399966
• Other study ID #: BIOAGELAB202201
• Status: Completed
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: June 2024
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Monarda Didyma extract
Monarda Didyma extract; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.
• Placebo
Maltodextrin; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Locations

Country	Name	City	State
Italy	Azienda Ospedale Università Padova	Padova	PD

Sponsors (2)

Lead Sponsor	Collaborator
Sofia Pavanello	Mibelle AG

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation age (DNAmAge)	DNA methylation age (years)	12 weeks
Primary	Age acceleration (AgeAcc)	Age acceleration as difference between DNA methylation age and chronological age (years)	12 weeks
Primary	Leukocyte telomere length (LTL)	Leukocyte telomere length as ratio (T/S) of number telomere repeat sequences (T) to single-copy gene (S)	12 weeks
Primary	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	Telomerase expression (??Ct)	Telomerase expression as comparative cycle threshold method (??Ct), which compares the difference in cycle threshold values between groups.	12 weeks
Secondary	Blood pressure	Blood pressure as systolic blood and diastolic blood pressure (mm Hg)	12 weeks
Secondary	Salivary cortisol	Salivary cortisol (nmol/L).	12 weeks
Secondary	Leukocytes	Leukocytes (10^9/L)	12 weeks
Secondary	erythrocytes	erythrocytes (10^12/L)	12 weeks
Secondary	hemoglobin	hemoglobin (g/L)	12 weeks
Secondary	hematocrit	hematocrit (L/L)	12 weeks
Secondary	MCV mean corpuscular volume	MCV (fL)	12 weeks
Secondary	MCH mean corpuscular hemoglobin	MCH (pg)	12 weeks
Secondary	MCHC mean corpuscular hemoglobin concentration	MCHC (g/L)	12 weeks
Secondary	platelets	platelets (10^9/L)	12 weeks
Secondary	C reactive protein	C reactive protein - CRP (mg/L)	12 weeks
Secondary	interleukin 6	interleukin 6 - IL6 (ng/L)	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Tracking of Hearth Rate using Miband 6 watch	hearth rate as beats per minute (BPM)	12 weeks
Secondary	Tracking of sleep using Miband 6 watch	sleep (hours)	12 weeks
Secondary	Tracking of mobility using Miband 6 watch	mobility (step counts)	12 weeks
Secondary	Total cholesterol	Total cholesterol (mg/dl)	12 weeks
Secondary	LDL	LDL (mg/dl)	12 weeks
Secondary	HDL	HDL (mg/dl)	12 weeks
Secondary	Triglycerides	Triglycerides (mg/dl)	12 weeks
Secondary	Glycemia	Glycemia (mg/dl)	12 weeks
Secondary	Insulin	Insulin (mcU/ml)	12 weeks
Secondary	HOMA	HOMA index - homeostasis model assessment	12 weeks
Secondary	AST	AST (IU/l) aspartate aminotransferase	12 weeks
Secondary	SGPT	SGPT (IU/l) Serum Glutamic Pyruvic Transaminase	12 weeks
Secondary	GGT	GGT (U/l) gamma glutamyl transferase	12 weeks
Secondary	Creatinine	Creatinine (mg/dl)	12 weeks
Secondary	Waist	Waist circumference (cm)	12 weeks
Secondary	Weight	Weight (kg)	12 weeks
Secondary	Total cholesterol/HDL	Total cholesterol/HDL	12 weeks
Secondary	LDL/HDL	LDL/HDL cholesterol ratio	12 weeks