protocolSection identificationModule nctId: NCT06295913, orgStudyIdInfo id: HYTOLIVE15, briefTitle: Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases, acronym: HYTOLIVE15, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: National Research Council, Spain, class: OTHER_GOV, collaborators name: Genosa I+D, descriptionModule briefSummary: The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging., conditionsModule conditions: Overweight, conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1, hydroxytyrosol-rich extract pill (Hytolive®); Group 2, placebo pill, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Group 1, hydroxytyrosol-rich extract capsule (Hytolive®), interventions name: Group 2, capsule of placebo, outcomesModule primaryOutcomes measure: LDL-ox as marker of oxidative status, secondaryOutcomes measure: Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale, secondaryOutcomes measure: Sleep quality determined by Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Fatigue test determined by Borg Rating Of Perceived Exertion, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: Glucagon-like peptide-1 (GLP-1), secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: High density lipoproteins (HDL), secondaryOutcomes measure: Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B), secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Apoliporpotein A1, secondaryOutcomes measure: Apoliporpotein B, secondaryOutcomes measure: Total antioxidant status (TAS), secondaryOutcomes measure: Total oxidative status (TOS), secondaryOutcomes measure: Oxides of nitrogen (NOx), secondaryOutcomes measure: Thiobarbituric acid reactive substances (TBARS), secondaryOutcomes measure: C reactive protein, secondaryOutcomes measure: Interleukine 6 (IL-6), secondaryOutcomes measure: Tumor necrosis factor alpha (TNF-α), secondaryOutcomes measure: Interleukine 10 (IL-10), secondaryOutcomes measure: Alanine aminotransfesare (transaminases ALT), secondaryOutcomes measure: Aspartate aminotransferase (transaminase AST), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC), status: RECRUITING, city: Madrid, state: Comunidad Autónoma De Madrid, zip: 28040, country: Spain, contacts name: Raquel Mateos, PhD, role: CONTACT, phone: +34 915492300, phoneExt: 436341, email: raquel.mateos@ictan.csic.es, contacts name: Mª Ángeles Martín, PhD, role: CONTACT, phone: +34 915492300, phoneExt: 436340, email: amartina@ictan.csic.es, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False