Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352099
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Dietary Supplementation and Cognitive Functions in the Elderly
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evaluation of Dietary Supplementation With Hesperidin and Proanthocyanidins on Cognitive and Motor Functions in Elderly Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPINS
Brief Summary:
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 21 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 individuals 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
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 individuals 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
Detailed Description:
Thirty-six patients evaluated and treated at the UOS Post-Acute Rehabilitation Fondazione Policlinico Universitario A Gemelli IRCCS Rome who meet the inclusion criteria will be recruited Patients will be divided into three groups by randomization as specified below One group G-Alt12 without any modification of the current pharmacological routine will take 1 stick per day of Altemor for 8 weeks do 4 weeks of wash-out and then take 2 sticks per day of Altemor for another 8 weeks the other group G-Alt21 without any modification of the current pharmacological routine will take 2 sticks per day of Altemor for 8 weeks do 4 weeks of wash-out and then take 1 stick per day of Altemor for another 8 weeks The third group G-con without any modification of the current drug routine if any will not take Altemor but will only be evaluated according to the endpoints in the study and described below
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None