Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary Supplement.
- Who it may be relevant to
- Registry conditions: Stroke, Hypoalbuminemia, Sarcopenia, Osteopenia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke: A Randomized Controlled Trial Investigating the Effect of Protein Supplementation on Functional Recovery, Sarcopenia, Osteopenia, and Nutritional Status in Stroke Patients With Hypoalbuminemia.
Overview
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.
Interventions
- Dietary supplement Dietary Supplement
complete, semi-elemental formula for tube feeding and orla intake based on peptides, in powder form, low in fat (32% of energy), high in MCTs (\>90% of total fat) free of fiber and gluten
Primary outcome measures
- Serum Albumin Levels [Time frame: Baseline and every 2 weeks for up to 6 weeks]
Secondary outcome measures (1)
- Muscle Mass (Whole-body DEXA) [Time frame: Baseline and at week 6]
Eligibility criteria
Inclusion criteria
- Age range: Adults aged 18 to 85 years
- Diagnosis: Patients diagnosed with a stroke (cerebrovascular accident) within the last 4 to 6 weeks
- Serum albumin levels: Patients with low serum albumin levels (< 3.5 g / dL)
- Nutritional intervention requirement: Patients who require nutritional intervention to support rehabilitation and nutrition
- Informed consent: Patients who have completed the consent form for participation in the study and acceptance of the intervention
Exclusion criteria
- Severe infections or serious cardiopulmonary conditions: Patients with severe infections or serious cardiopulmonary conditions requiring immediate medical intervention, which may affect nutrition and rehabilitation
- Comorbidities: Patients with comorbid conditions such as renal or liver disease
- History of stroke or neurological conditions: Patients with a history of stroke or other neurological conditions who do not meet the criteria for rehabilitation
- Severe mental or psychological conditions: Patients with severe mental or psychological conditions who are unable to understand or consent to participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Greece · 1 center
- University Hospital of Ioannina — Ioannina
Identifiers
NCT: NCT06961825 · University of Ioannina