protocolSection identificationModule nctId: NCT06352099, orgStudyIdInfo id: 6315, briefTitle: Dietary Supplementation and Cognitive Functions in the Elderly, acronym: ESPINS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: In recent years, globally, there has been a growth in both the size and the proportion of older adults in the world population. The World Health Organization (WHO) has estimated that by 2030, 1 in 6 people will be 60 years of age or older, and that by 2050, the population of older adults will reach 2.1 billion. The population of older adults (over 80 years) will triple to 426 million by 2050. In particular, Italy represents the second country with the oldest population in the world.Age-related evolution is a gradual and continuous process involving a series of physical and cognitive changes, which, however, has no real 'onset' age. In fact, rather than chronological age, the concept of 'elderly' is based on the individual's degree of self-sufficiency and independence. From a biological point of view, ageing is the set of changes at the molecular and cellular level that occur over time and lead to multi-system functional impairment. It is a process directly related to frailty, falls, and disability.An important factor in counteracting frailty is nutritional intake. Humans ingest approximately 500 g of chemical compounds daily through their diet, most of which are components of plants or vegetables in general. In addition to the well-known macronutrients (proteins, fats, and carbohydrates) and micronutrients (minerals and vitamins), the plant world provides other elements, such as phenols, terpenes, terpenoids, alkaloids, purines, pyrimidines, nucleic acids, and steroids, that exert powerful biological activities. These components are generically called phytochemicals. Epidemiological studies have established that diets rich in plant-based foods help prevent many diseases, such as cardiovascular, metabolic, neurovegetative, and inflammatory diseases.Phytochemical compounds are an extremely diverse set of elements that, when taken at significant levels, have a protective effect on human health. These substances exert various biological functions, such as antioxidant activity, modulation of detoxifying enzymes, stimulation of the immune system, reduction of platelet aggregation, modulation of hormone metabolism, reduction of blood pressure, and antibacterial and antiviral activity.Among the phytochemical compounds, flavonoids represent a category of polyfunctional substances with high bioactivity, comprising more than 5000 compounds. They possess biochemical properties of functional interest in the nutritional and therapeutic fields; for example, rutin, diosmin, and hesperidin are present in some pharmaceutical specialties; flavonoids from ginkgo biloba, hawthorn, and red vine are the main components of many phytotherapeutic extracts. Flavonoids have been shown to play an important role in cardioprotection. Furthermore, in neuroprotection, anthocyanin-rich fruits play a protective role against age-related decline in cognitive functions.However, few studies have evaluated the effect of hesperidin and proanthocyanidins on motor, cognitive, and functional aspects in the elderly.Altemor® is a food supplement based on micronized diosmin, hesperidin, and herbal extracts that has an important integrative supporting action in optimising blood microcirculation.The aim of the study is to evaluate the contribution of dietary supplementation with Altemor® on cognitive function, balance, fatigue, and some domains of quality of life in elderly subjects., conditionsModule conditions: Cognitive Impairment, conditions: Old Age; Debility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Dietary supplement with micronised diosmin, hesperidin and herbal extracts, outcomesModule primaryOutcomes measure: Trial Making Test (TMT), secondaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: HandGrip Strenght Test (HGST), secondaryOutcomes measure: Silver Index (SI), secondaryOutcomes measure: Mental Deterioration battery (MDB), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: EuroQol- 5 Dimension (EQ-5D), secondaryOutcomes measure: Modified Fatigue Impact Scale (MFIS), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, state: RM, zip: 00168, country: Italy, contacts name: Silvia Giovannini, MD, PhD, role: CONTACT, phone: +390630154382, email: silvia.giovannini@policlinicogemelli.it, contacts name: Letizia Castelli, PhD, role: CONTACT, phone: +390630154382, email: letizia.castelli@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False