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

Sofia Pavanello

Status: Completed

Conditions: Aging

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Monarda Didyma extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05399966

BIOAGELAB202201

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Monarda Didyma extract

Experimental group

Description:

Monarda Didyma extract

Treatment:

Dietary Supplement: Monarda Didyma extract

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo