Effects of Nutrition on Post Stroke Fatigue

NCT ID: NCT05728229

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2025-12-31

Brief Summary

Fatigue, which is commonly defined as a feeling of tiredness during or after usual activities, or a feeling of insufficient energy to initiate these activities, is one of the most common secondary conditions among patients presenting with stroke.

Post Stroke Fatigue (PSF) is a multidimensional motor-perceptual, emotional, and cognitive experience characterized by a feeling of early exhaustion with tiredness, lack of energy, and difficulty making efforts, which develops during physical or mental activities, and usually does not improve with rest.

To try to counteract fatigue and its effects on daily life activities, in addition to the known pharmacological approach (Modafinil), the use of vitamins and minerals is known to mitigate, among others, the effects of fatigue. Nutrients provide the energy needed to maintain the body's structural and biochemical integrity. Energy is associated with a feeling of well-being, increased stamina and vitality which often translates into the ability to undertake daily physical or cognitive activities and social relationships, as opposed to fatigue.

A common feature of fatigue is a "sense of energy exhaustion" which can objectively be related to not enough energy. Physical and cognitive tiredness occurs when the continuous demand for energy from the brain and muscles is not met. In humans, dietary macronutrients provide the fuel needed, among other things, to perform physical activity. In fact, mineral salts and vitamins are essential for the production of cellular energy, for the maintenance of brain structures and for allowing the formation of intercellular connections.

When the intake of vitamins and mineral salts is adequate, their biochemical properties translate into normal physiological functions; a lower intake of mineral salts and vitamins is associated with lethargy and physical and cognitive fatigue. However, few studies have evaluated the effect of vitamin and mineral supplementation for the management of physical and cognitive fatigue.

SiderAL® Med is a food for Special Medical Purposes (AFMS), with a complete formulation that contains vitamins, sucrosomial minerals (Iron, Iodine, Magnesium, Zinc and Selenium), copper and algal calcium, with enhanced dosages to meet particular needs nutritional. AFMS are products formulated for the dietary management of patients with proven nutritional needs, for whom modifications to the normal diet are not sufficient.

In some cases, these are subjects with limited, disturbed or altered ability to take, digest, absorb, metabolize or eliminate certain nutrients, in other cases, however, nutritional needs can be determined by specific clinical conditions.

On the basis of scientific evidences, therefore, the aim of the study is to evaluate whether the nutritional supplement with SiderAL® Med improves the symptom of fatigue, motor and cognitive function in patients with stroke outcomes.

Detailed Description

Twenty-four patients of both sexes will be recruiteed, evaluated and treated at the Post-Acute Rehabilitation Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome.

Patients will be divided into two groups by randomization, as specified later. One group (experimental group, GS), in association with the drug therapy already underway, will take the nutritional supplement with SiderAL® Med 1 sachet per day for 28 consecutive days, while another group will continue its clinical and rehabilitation treatment as per the daily routine (control group, GC).

Conditions

Fatigue; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group (GS)

GS patients, in addition to the pharmacological therapy foreseen by the clinical conditions, will take 1 sachet a day of SiderAl® Med, a food for special purposes, for 28 days. GS patients will take the food for special purposes during hospitalization (between T0 and T1) and during the 1 month of returning home (between T1 and T2). During the second month of returning home (between T2 and T3), GS patients will no longer take the food for special purposes.

Group Type: EXPERIMENTAL

Supplement with SiderAl® Med

Intervention Type: DRUG

Nutritional supplementation with special purpose food

Control Group (GC)

The patients of the GC, on the other hand, will continue to take the drug as required by their clinical conditions and will not take the SiderAL® Med food for special purposes, but will only be observed and evaluated at the various time-points foreseen by the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supplement with SiderAl® Med

Nutritional supplementation with special purpose food

Intervention Type: DRUG

Other Intervention Names

SiderAl® Med

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 5 years;
• Patients with ischemic or haemorrhagic stroke outcomes documented through neuroimaging techniques (magnetic resonance or computed tomography);
• Latency from the acute event between 1 and 6 months;
• Cognitive skills that allow you to carry out simple orders and understand the physiotherapist's instructions [assessed through the Token Test (score ≥ 26.5)];
• Ability to walk independently or with little assistance;
• Ability to understand and sign informed consent.

Exclusion Criteria

• Vitamin D intake greater than 3000 IU/day;
• Therapy with Vitamin K antagonists;
• Conditions causing excess electrolytes in the blood;
• Diagnosis of metabolic mineral storage disorders (eg, hemochromatosis, Wilson);
• Dialysis patients;
• Systemic, neurological, cardiac pathologies that make walking risky or cause motor deficits;
• Oncological pathologies;
• Problems of an orthopedic or postural nature;
• Presence of plantar ulcers;
• Partial or total amputation of segments of the foot;
• Inability to provide informed consent.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

GIOVANNINI SILVIA

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Giovannini, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia Giovannini, MD, phD

Role: CONTACT

silvia.giovannini@policlinicogemelli.it

+390630154382

Letizia Castelli, MS

Role: CONTACT

letizia.castelli@policlinicogemelli.it

+390630154382

Facility Contacts

Silvia Giovannini, MD, phD

Role: primary

silvia.giovannini@policlinicogemelli.it

+390630154382

Letizia Castelli, MS

Role: backup

letizia.castelli@policlinicogemelli.it

+390630154382

Other Identifiers

0033318/22

Identifier Type: -

Identifier Source: org_study_id