Effects of Monarda Didyma Extract Supplementation on Biological Ageing

Study Overview
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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.

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

Conditions
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Aging

Intervention / Treatment
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* Dietary Supplement: Monarda Didyma extract
* Dietary Supplement: Placebo


Participation Criteria
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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 The subject is of a susceptible working population which may include shift workers, nurses, landscape/construction workers 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study; randomized, placebo-controlled, double-blind, parallel design, monocentric.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |