Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT05399966
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2022-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Monarda Didyma Extract Supplementation on Biological Ageing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot study; randomized, placebo-controlled, double-blind, parallel design, monocentric.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA methylation age (DNAmAge)', 'timeFrame': '12 weeks', 'description': 'DNA methylation age (years)'}, {'measure': 'Age acceleration (AgeAcc)', 'timeFrame': '12 weeks', 'description': 'Age acceleration as difference between DNA methylation age and chronological age (years)'}, {'measure': 'Leukocyte telomere length (LTL)', 'timeFrame': '12 weeks', 'description': 'Leukocyte telomere length as ratio (T/S) of number telomere repeat sequences (T) to single-copy gene (S)'}, {'measure': 'Mitochondrial DNA copy number (mtDNAcn)', 'timeFrame': '12 weeks', 'description': 'Mitochondrial DNA copy number (mtDNAcn) as ratio (MT/S) of mitochondrial DNA copy number (MT) and the singular copy number of a gene (S)'}], 'secondaryOutcomes': [{'measure': 'Telomerase expression (∆∆Ct)', 'timeFrame': '12 weeks', 'description': 'Telomerase expression as comparative cycle threshold method (∆∆Ct), which compares the difference in cycle threshold values between groups.'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'Blood pressure as systolic blood and diastolic blood pressure (mm Hg)'}, {'measure': 'Salivary cortisol', 'timeFrame': '12 weeks', 'description': 'Salivary cortisol (nmol/L).'}, {'measure': 'Leukocytes', 'timeFrame': '12 weeks', 'description': 'Leukocytes (10\\^9/L)'}, {'measure': 'erythrocytes', 'timeFrame': '12 weeks', 'description': 'erythrocytes (10\\^12/L)'}, {'measure': 'hemoglobin', 'timeFrame': '12 weeks', 'description': 'hemoglobin (g/L)'}, {'measure': 'hematocrit', 'timeFrame': '12 weeks', 'description': 'hematocrit (L/L)'}, {'measure': 'MCV mean corpuscular volume', 'timeFrame': '12 weeks', 'description': 'MCV (fL)'}, {'measure': 'MCH mean corpuscular hemoglobin', 'timeFrame': '12 weeks', 'description': 'MCH (pg)'}, {'measure': 'MCHC mean corpuscular hemoglobin concentration', 'timeFrame': '12 weeks', 'description': 'MCHC (g/L)'}, {'measure': 'platelets', 'timeFrame': '12 weeks', 'description': 'platelets (10\\^9/L)'}, {'measure': 'C reactive protein', 'timeFrame': '12 weeks', 'description': 'C reactive protein - CRP (mg/L)'}, {'measure': 'interleukin 6', 'timeFrame': '12 weeks', 'description': 'interleukin 6 - IL6 (ng/L)'}, {'measure': "Questionnaire about Quality of Life: World Health Organization's Quality of Life Assessment BREF version (WHOQOL-BREF)", 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Questionnaire about sleeping patterns: Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Tracking of Hearth Rate using Miband 6 watch', 'timeFrame': '12 weeks', 'description': 'hearth rate as beats per minute (BPM)'}, {'measure': 'Tracking of sleep using Miband 6 watch', 'timeFrame': '12 weeks', 'description': 'sleep (hours)'}, {'measure': 'Tracking of mobility using Miband 6 watch', 'timeFrame': '12 weeks', 'description': 'mobility (step counts)'}, {'measure': 'Total cholesterol', 'timeFrame': '12 weeks', 'description': 'Total cholesterol (mg/dl)'}, {'measure': 'LDL', 'timeFrame': '12 weeks', 'description': 'LDL (mg/dl)'}, {'measure': 'HDL', 'timeFrame': '12 weeks', 'description': 'HDL (mg/dl)'}, {'measure': 'Triglycerides', 'timeFrame': '12 weeks', 'description': 'Triglycerides (mg/dl)'}, {'measure': 'Glycemia', 'timeFrame': '12 weeks', 'description': 'Glycemia (mg/dl)'}, {'measure': 'Insulin', 'timeFrame': '12 weeks', 'description': 'Insulin (mcU/ml)'}, {'measure': 'HOMA', 'timeFrame': '12 weeks', 'description': 'HOMA index - homeostasis model assessment'}, {'measure': 'AST', 'timeFrame': '12 weeks', 'description': 'AST (IU/l) aspartate aminotransferase'}, {'measure': 'SGPT', 'timeFrame': '12 weeks', 'description': 'SGPT (IU/l) Serum Glutamic Pyruvic Transaminase'}, {'measure': 'GGT', 'timeFrame': '12 weeks', 'description': 'GGT (U/l) gamma glutamyl transferase'}, {'measure': 'Creatinine', 'timeFrame': '12 weeks', 'description': 'Creatinine (mg/dl)'}, {'measure': 'Waist', 'timeFrame': '12 weeks', 'description': 'Waist circumference (cm)'}, {'measure': 'Weight', 'timeFrame': '12 weeks', 'description': 'Weight (kg)'}, {'measure': 'Total cholesterol/HDL', 'timeFrame': '12 weeks', 'description': 'Total cholesterol/HDL'}, {'measure': 'LDL/HDL', 'timeFrame': '12 weeks', 'description': 'LDL/HDL cholesterol ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '30301216', 'type': 'BACKGROUND', 'citation': 'Yao Q, Lin MT, Zhu YD, Xu HL, Zhao YZ. Recent Trends in Potential Therapeutic Applications of the Dietary Flavonoid Didymin. Molecules. 2018 Oct 6;23(10):2547. doi: 10.3390/molecules23102547.'}, {'pmid': '33182043', 'type': 'BACKGROUND', 'citation': 'Feng Z, Pang L, Chen S, Pang X, Huang Y, Qiao Q, Wang Y, Vonglorkham S, Huang Q, Lin X, Wei J. Didymin ameliorates dexamethasone-induced non-alcoholic fatty liver disease by inhibiting TLR4/NF-kappaB and PI3K/Akt pathways in C57BL/6J mice. Int Immunopharmacol. 2020 Nov;88:107003. doi: 10.1016/j.intimp.2020.107003. Epub 2020 Sep 23.'}, {'pmid': '27997902', 'type': 'BACKGROUND', 'citation': 'Lin X, Bai F, Nie J, Lu S, Lu C, Zhu X, Wei J, Lu Z, Huang Q. Didymin Alleviates Hepatic Fibrosis Through Inhibiting ERK and PI3K/Akt Pathways via Regulation of Raf Kinase Inhibitor Protein. Cell Physiol Biochem. 2016;40(6):1422-1432. doi: 10.1159/000453194. Epub 2016 Dec 20.'}, {'pmid': '31450859', 'type': 'BACKGROUND', 'citation': 'Pavanello S, Campisi M, Tona F, Lin CD, Iliceto S. Exploring Epigenetic Age in Response to Intensive Relaxing Training: A Pilot Study to Slow Down Biological Age. Int J Environ Res Public Health. 2019 Aug 23;16(17):3074. doi: 10.3390/ijerph16173074.'}, {'pmid': '34368190', 'type': 'BACKGROUND', 'citation': 'Campisi M, Liviero F, Maestrelli P, Guarnieri G, Pavanello S. DNA Methylation-Based Age Prediction and Telomere Length Reveal an Accelerated Aging in Induced Sputum Cells Compared to Blood Leukocytes: A Pilot Study in COPD Patients. Front Med (Lausanne). 2021 Jul 23;8:690312. doi: 10.3389/fmed.2021.690312. eCollection 2021.'}, {'pmid': '32612244', 'type': 'BACKGROUND', 'citation': 'Pavanello S, Campisi M, Fabozzo A, Cibin G, Tarzia V, Toscano G, Gerosa G. The biological age of the heart is consistently younger than chronological age. Sci Rep. 2020 Jul 1;10(1):10752. doi: 10.1038/s41598-020-67622-1.'}, {'pmid': '23885040', 'type': 'BACKGROUND', 'citation': 'Pavanello S, Dioni L, Hoxha M, Fedeli U, Mielzynska-Svach D, Baccarelli AA. Mitochondrial DNA copy number and exposure to polycyclic aromatic hydrocarbons. Cancer Epidemiol Biomarkers Prev. 2013 Oct;22(10):1722-9. doi: 10.1158/1055-9965.EPI-13-0118. Epub 2013 Jul 24.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations\n* Age: 45 - 65\n\nExclusion Criteria:\n\n* 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))\n* Chronic intake of medication/dietary supplements with impact on stress levels (psychologically and physiological)\n* Consumption of any dietary/nutritional supplements or functional foods\n* Smokers\n* High caffeine intake \\> 5 coffee cups / day\n* Gastrointestinal diseases/conditions (ulcerative colitis, Crohn's disease, peptic ulcers, celiac disease)\n* Drug-, alcohol- and medication abuses\n* Known HIV-infection\n* Known acute or chronic hepatitis B and C infection\n* Known allergies against the mint family (labiate), especially lemon balm (la cedrella, la melissa, la citronella)\n* Pregnancy, breastfeeding or intention to become pregnant during the study\n* Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study\n* Blood donation within 4 weeks prior to study start (screening) or during the study\n* Anticipating any planned changes in lifestyle for the duration of the study\n* Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT05399966', 'acronym': 'EMODISU', 'briefTitle': 'Effects of Monarda Didyma Extract Supplementation on Biological Ageing', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Investigating the Effects of Monarda Didyma Extract Supplementation on Biological Aging of Susceptible Population: a Randomized, Placebo Controlled, Double Blind Parallel Study', 'orgStudyIdInfo': {'id': 'BIOAGELAB202201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monarda Didyma extract', 'description': 'Monarda Didyma extract', 'interventionNames': ['Dietary Supplement: Monarda Didyma extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Monarda Didyma extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Monarda Didyma extract; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.', 'armGroupLabels': ['Monarda Didyma extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin; 100 mg/d. 1capsules/day; daily (1 capsule with the lunch) and plenty of water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'state': 'PD', 'country': 'Italy', 'facility': 'Azienda Ospedale Università Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sofia Pavanello', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mibelle AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Sofia Pavanello', 'investigatorAffiliation': 'University of Padova'}}}}