Effects of Monarda Didyma Extract Supplementation on Biological Ageing (EMODISU)

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Monarda Didyma extract; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PD
    • Padova, PD, Italy, 35128
      • Azienda Ospedale Universita Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; Maltodextrin; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.
Experimental: Monarda Didyma extract	Dietary supplement: Monarda Didyma extract; Monarda Didyma extract; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telomerase expression (∆∆Ct)	Telomerase expression as comparative cycle threshold method (∆∆Ct), which compares the difference in cycle threshold values between groups.	12 weeks
Blood pressure	Blood pressure as systolic blood and diastolic blood pressure (mm Hg)	12 weeks
Salivary cortisol	Salivary cortisol (nmol/L).	12 weeks
Leukocytes	Leukocytes (10^9/L)	12 weeks
erythrocytes	erythrocytes (10^12/L)	12 weeks
hemoglobin	hemoglobin (g/L)	12 weeks
hematocrit	hematocrit (L/L)	12 weeks
MCV mean corpuscular volume	MCV (fL)	12 weeks
MCH mean corpuscular hemoglobin	MCH (pg)	12 weeks
MCHC mean corpuscular hemoglobin concentration	MCHC (g/L)	12 weeks
platelets	platelets (10^9/L)	12 weeks
C reactive protein	C reactive protein - CRP (mg/L)	12 weeks
interleukin 6	interleukin 6 - IL6 (ng/L)	12 weeks
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
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
Tracking of Hearth Rate using Miband 6 watch	hearth rate as beats per minute (BPM)	12 weeks
Tracking of sleep using Miband 6 watch	sleep (hours)	12 weeks
Tracking of mobility using Miband 6 watch	mobility (step counts)	12 weeks
Total cholesterol	Total cholesterol (mg/dl)	12 weeks
LDL	LDL (mg/dl)	12 weeks
HDL	HDL (mg/dl)	12 weeks
Triglycerides	Triglycerides (mg/dl)	12 weeks
Glycemia	Glycemia (mg/dl)	12 weeks
Insulin	Insulin (mcU/ml)	12 weeks
HOMA	HOMA index - homeostasis model assessment	12 weeks
AST	AST (IU/l) aspartate aminotransferase	12 weeks
SGPT	SGPT (IU/l) Serum Glutamic Pyruvic Transaminase	12 weeks
GGT	GGT (U/l) gamma glutamyl transferase	12 weeks
Creatinine	Creatinine (mg/dl)	12 weeks
Waist	Waist circumference (cm)	12 weeks
Weight	Weight (kg)	12 weeks
Total cholesterol/HDL	Total cholesterol/HDL	12 weeks
LDL/HDL	LDL/HDL cholesterol ratio	12 weeks

Collaborators and Investigators

• Sponsor: Sofia Pavanello
• Collaborators: Mibelle AG

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BIOAGELAB202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No