NCT06961825: Nutristroke

Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.

Not yet recruiting NA Last updated 8 May 2025

What this trial tests

NA trial testing Dietary Supplement in Stroke in 100 participants. Not yet recruiting.

Timeline

5 May 2025

Primary endpoint
5 May 2030

5 May 2030

Quick facts

Lead sponsor	University of Ioannina
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	5 May 2025
Primary completion	5 May 2030
Estimated completion	5 May 2030
Sites	1 location across Greece

Drugs / interventions tested

• Dietary Supplement — full drug profile →

Conditions studied

• Stroke — all drugs for Stroke →
• Hypoalbuminemia — all drugs for Hypoalbuminemia →
• Sarcopenia — all drugs for Sarcopenia →
• Osteopenia — all drugs for Osteopenia →

Sponsor

University of Ioannina

Who can join

Adults 18 to 85, any sex, with Stroke or Hypoalbuminemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Brief Summary: The main objective of this thesis is to investigate the role of nutrition - specifically the administration of protein supplements (single dose and double dose) - in the rehabilitation of stroke patients with low albumin levels in relation to sarcopenia, osteopenia and functional recovery indices. The study will follow a randomized controlled trial design, incorporating clinical observation, analysis of biochemical markers, and assessment of physical and functional parameters. Participants will be randomly assigned to one of the three groups: (1) Group 1, receiving no protein supplementation (control group), (2) Group 2, receiving a single dose of protein supplement and (3) Group 3, receiving a double dose of protein supplement. The intervention will last for at least six weeks or until the biochemical markers of albumin normalize and the patient resumes regular oral intake. Biochemical assessment with be conducted through regular nutritional evaluations including measurement of serum albumin, prealbumin, C - reactive protein, creatinine, blood glucose and glycosylated hemoglobin (HbA1c), urea, electrolytes, urine albumin and additional inflammatory markers. Bone density will be assessed using DEXA, MBSR and hip measurements to determine the potential improvements resulting from the intervention. Muscle mass will be evaluated using whole - body DEXA analysis, while muscle strength and mobility will be assessed through grip strength tests and fine gait assessments. Functional recovery will be evaluated usings standardized tools for activities of daily living (Barthel Index), mental state (Geriatric Depression Scale) and quality of life (SF - 36), as well as mobility and walking tests such as the Timed Up and Go Test and 6 - Minute Walk Test. The collected data will be analyzed using appropriate statistical tools, including comparison models (ANOVA, Mann - Whitney U test) and correlation models (Pearson - Spearman). This research is expected to enhance theoretical knowledge regarding the relationship between nutrition, biochemical markers and rehabilitation outcomes in stroke patients with hypoalbuminemia. More specifically, it aims to explore the underlying mechanisms through which nutrition affects recovery - a field that remains unexplored. Additionally, the anticipated finding may contribute to the development of clinical guidelines and therapeutic approaches for the nutritional management of patients with low albumin levels, promoting personalized nutritional strategies that support effective post - stroke rehabilitation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.