Effects of Monarda Didyma Extract Supplementation on Biological Ageing
- Conditions
- Aging
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Monarda Didyma extract
- Registration Number
- NCT05399966
- Lead Sponsor
- Sofia Pavanello
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Maltodextrin Monarda Didyma extract Monarda Didyma extract Monarda Didyma extract
- Primary Outcome Measures
Name Time Method Age acceleration (AgeAcc) 12 weeks Age acceleration as difference between DNA methylation age and chronological age (years)
DNA methylation age (DNAmAge) 12 weeks DNA methylation age (years)
Leukocyte telomere length (LTL) 12 weeks Leukocyte telomere length as ratio (T/S) of number telomere repeat sequences (T) to single-copy gene (S)
Mitochondrial DNA copy number (mtDNAcn) 12 weeks Mitochondrial DNA copy number (mtDNAcn) as ratio (MT/S) of mitochondrial DNA copy number (MT) and the singular copy number of a gene (S)
- Secondary Outcome Measures
Name Time Method Tracking of sleep using Miband 6 watch 12 weeks sleep (hours)
hemoglobin 12 weeks hemoglobin (g/L)
erythrocytes 12 weeks erythrocytes (10\^12/L)
Blood pressure 12 weeks Blood pressure as systolic blood and diastolic blood pressure (mm Hg)
Salivary cortisol 12 weeks Salivary cortisol (nmol/L).
MCH mean corpuscular hemoglobin 12 weeks MCH (pg)
platelets 12 weeks platelets (10\^9/L)
Telomerase expression (∆∆Ct) 12 weeks Telomerase expression as comparative cycle threshold method (∆∆Ct), which compares the difference in cycle threshold values between groups.
C reactive protein 12 weeks C reactive protein - CRP (mg/L)
interleukin 6 12 weeks interleukin 6 - IL6 (ng/L)
Questionnaire about Quality of Life: World Health Organization's Quality of Life Assessment BREF version (WHOQOL-BREF) 12 weeks 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.
Tracking of mobility using Miband 6 watch 12 weeks mobility (step counts)
HOMA 12 weeks HOMA index - homeostasis model assessment
SGPT 12 weeks SGPT (IU/l) Serum Glutamic Pyruvic Transaminase
LDL/HDL 12 weeks LDL/HDL cholesterol ratio
MCV mean corpuscular volume 12 weeks MCV (fL)
HDL 12 weeks HDL (mg/dl)
AST 12 weeks AST (IU/l) aspartate aminotransferase
hematocrit 12 weeks hematocrit (L/L)
MCHC mean corpuscular hemoglobin concentration 12 weeks MCHC (g/L)
Weight 12 weeks Weight (kg)
Questionnaire about sleeping patterns: Pittsburgh Sleep Quality Index (PSQI) 12 weeks 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.
Tracking of Hearth Rate using Miband 6 watch 12 weeks hearth rate as beats per minute (BPM)
Triglycerides 12 weeks Triglycerides (mg/dl)
Glycemia 12 weeks Glycemia (mg/dl)
Insulin 12 weeks Insulin (mcU/ml)
Total cholesterol/HDL 12 weeks Total cholesterol/HDL
Total cholesterol 12 weeks Total cholesterol (mg/dl)
LDL 12 weeks LDL (mg/dl)
Leukocytes 12 weeks Leukocytes (10\^9/L)
GGT 12 weeks GGT (U/l) gamma glutamyl transferase
Creatinine 12 weeks Creatinine (mg/dl)
Waist 12 weeks Waist circumference (cm)
Trial Locations
- Locations (1)
Azienda Ospedale Università Padova
🇮🇹Padova, PD, Italy