Dietary Supplementation and Cognitive Functions in the Elderly

NCT06352099 | Completed

• 1 other identifier: 6315
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Old Age; Debility

Keywords

Elderly; Cognitive performance; Fatigue; Quality of life; Falls; Nutraceutical

Outcome Measures

Primary Outcomes (1)

• Trial Making Test (TMT)

  The TMT measures flexibility of thinking on a visual-motor sequencing task. It consists of two parts, A and B, where 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Trail A: Average 29 seconds, Deficient \> 78 seconds, Rule of Thumb Most in 90 seconds Trail B: Average 75 seconds, Deficient \> 273 seconds, Rule of Thumb Most in 3 minutes

  Change from Baseline TMT at 8 and 16 weeks

Secondary Outcomes (7)

• Short Physical Performance Battery (SPPB)

  Change from Baseline SPPB at 8 and 16 weeks

• HandGrip Strenght Test (HGST)

  Change from Baseline HGST at 8 and 16 weeks

• Silver Index (SI)

  Change from Baseline SI at 8 and 16 weeks

• Mental Deterioration battery (MDB)

  Change from Baseline MDB at 8 and 16 weeks

• Hospital Anxiety and Depression Scale (HADS)

  Change from Baseline HADS at 8 and 16 weeks

Study Arms (3)

G-Alt12

EXPERIMENTAL

G-Alt12 patients, without making any changes to their current drug routine, will take 1 stick per day of Altemor® for 8 weeks, go for a period of 4 weeks without taking the food supplement, and then take 2 sticks per day of Altemor® for another 8 weeks.

Dietary Supplement: Dietary supplement with micronised diosmin, hesperidin and herbal extracts

G-Alt21

EXPERIMENTAL

G-Alt21 patients, without making any changes to their current medication routine, will take 2 sticks per day of Altemor® for 8 weeks, do a 4-week period without taking the dietary supplement, and then take 1 stick per day of Altemor® for another 8 weeks.

Dietary Supplement: Dietary supplement with micronised diosmin, hesperidin and herbal extracts

G-Con

NO INTERVENTION

G-Con patients will undergo clinical and instrumental evaluations at the study endpoints

Interventions

Dietary supplement with micronised diosmin, hesperidin and herbal extracts DIETARY_SUPPLEMENT

Taking a dietary supplement with micronised diosmin, hesperidin and plant extracts 1 or 2 sticks per day, as per the study design.

Also known as: Altemor®

G-Alt12; G-Alt21

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Related Publications (1)

• Giovannini S, Lauria A, Malizia AM, Lama E, Morciano N, Biscotti L, Loreti C, Castelli L. The Effectiveness of Hesperidin, Diosmin and Proanthocyanidins Nutritional Supplementation on Cognitive and Motor Functions in Older Adults: A Pilot Randomized Control Study. J Am Nutr Assoc. 2026 Jan;45(1):24-36. doi: 10.1080/27697061.2025.2526600. Epub 2025 Jul 22.

  PMID: 40694049 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Frailty; Fatigue

Interventions

Dietary Supplements; Hesperidin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Study Officials

• Silvia Giovannini, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 2, 2024
• Primary Completion: November 15, 2024
• Study Completion: February 17, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)