Effects of Monarda Didyma Extract Supplementation on Biological Ageing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2024-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot study; randomized, placebo-controlled, double-blind, parallel design, monocentric.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Monarda Didyma extract

Group Type EXPERIMENTAL

Monarda Didyma extract

Intervention Type DIETARY_SUPPLEMENT

Monarda Didyma extract; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Interventions

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Monarda Didyma extract

Monarda Didyma extract; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes