Effects of Monarda Didyma Extract Supplementation on Biological Ageing

Sofia Pavanello81 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Aging

Interventions

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Azienda Ospedale Università Padova

Padua, PD, Italy

Outcomes

Primary Outcomes

DNA methylation age (DNAmAge)

DNA methylation age (years)

Time frame: 12 weeks

Age acceleration (AgeAcc)

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

Time frame: 12 weeks

Leukocyte telomere length (LTL)

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

Time frame: 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)

Time frame: 12 weeks

Secondary Outcomes

Telomerase expression (∆∆Ct)

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

Time frame: 12 weeks

Blood pressure

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

Time frame: 12 weeks

Salivary cortisol

Salivary cortisol (nmol/L).

Time frame: 12 weeks

Leukocytes

Leukocytes (10\^9/L)

Time frame: 12 weeks

erythrocytes

Data from ClinicalTrials.gov

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