NCT05728229

Effects of Nutrition on Post Stroke Fatigue

Effetti Della Nutrizione Sulla Fatica Post Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Supplement with SiderAl® Med	Nutritional supplementation with special purpose food

Timeline

• Start date: 2022-11-07
• Primary completion: 2024-09-29
• Completion: 2025-12-01
• First posted: 2023-02-15
• Last updated: 2025-07-14

Locations

1 site across 1 country: Italy