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

NCT ID: NCT06961825

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2030-05-05

Brief Summary

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.

Conditions

Stroke; Hypoalbuminemia; Sarcopenia; Osteopenia; Malnutrition (Calorie); Protein-energy Malnutrition; Functional Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Protein Supplement - Single Dose

Participants in this arm will receive one dose of protein supplement daily.

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: 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

Protein Supplement - Double Dose

Participants in this arm will receive two doses of protein supplement daily.

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: 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

Control group

no protein supplementation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ioannina

OTHER

Sponsor Role: lead

Responsible Party

Avraam Ploumis

Assistan Professor of PMR,Orthopaedic Spine Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avraam Ploumis

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ioannina

Locations

University Hospital of Ioannina

Ioannina, Greece, Greece

Countries

Greece

Central Contacts

ΑΒΡΑΑΜ Πλούμης

Role: CONTACT

aploumis@uoi.gr

+306932080701

Avraam Ploumis

Role: CONTACT

Other Identifiers

University of Ioannina

Identifier Type: -

Identifier Source: org_study_id