Clinical trial NCT06352099: Dietary Supplementation and Cognitive Functions in the Elderly
Official title: Evaluation of Dietary Supplementation With Hesperidin and Proanthocyanidins on Cognitive and Motor Functions in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Old Age; Debility
Keywords: Elderly
Cognitive performance
Fatigue
Quality of life
Falls
Nutraceutical
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 25 and 32 kg/m2
* Non-smoker
* Cognitive ability to carry out simple orders and to understand the physiotherapist's instructions \[assessed by the Mini Mental State Examination (correct score between 22 and 27)\]
* Independence in instrumental activities of daily living \[assessed by the Instrumental Activities of Daily Living (score \< 5)
* Medication stability of at least 12 months for taking any medication for hypertension, hyperlipidemia, inflammation, hypercholesterolemiaand hypercoagulation;
* Ability to walk independently or with little assistance;
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Previous history of stroke and/or myocardial infarction;
* Presence of altered mood \[assessed by the Hospital Anxiety and Depression Scale (score ≤ 8)\].
* Presence of kidney or intestinal disease, pancreatitis, diabetes or any other endocrine disorder
* Presence of demyelinating and dysmyelinating diseases;
* Presence of anticoagulant or antiplatelet drugs;
* Systemic, neurological or cardiac diseases that make walking unsafe or cause motor deficits;
* Oncological pathologies;
* Vegetarian diet, regular intake of supplements including fish oil, fatty acids, vitamins and minerals
* Orthopaedic or postural problems;
* Presence of plantar ulcers;
* Partial or total amputation of foot segments.
* Inability to provide informed consent.

Primary outcomes:
measure: Trial Making Test (TMT)
timeFrame: Change from Baseline TMT at 8 and 16 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline SPPB at 8 and 16 weeks
measure: HandGrip Strenght Test (HGST)
timeFrame: Change from Baseline HGST at 8 and 16 weeks
measure: Silver Index (SI)
timeFrame: Change from Baseline SI at 8 and 16 weeks
measure: Mental Deterioration battery (MDB)
timeFrame: Change from Baseline MDB at 8 and 16 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline HADS at 8 and 16 weeks
measure: EuroQol- 5 Dimension (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 8 and 16 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline MFIS at 8 and 16 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Silvia Giovannini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: