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NCT Number: NCT06961825

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 outcomes

  1. Serum Albumin Levels

    Time frame: Baseline and every 2 weeks for up to 6 weeks

    Change in serum albumin concentration to assess nutritional status and response to protein supplementation.

Secondary outcomes

  1. Muscle Mass (Whole-body DEXA)

    Time frame: Baseline and at week 6

    Evaluation of changes in muscle mass using DEXA scan.

Study contacts

Contact information is provided by the study sponsor or research team.

Avraam Ploumis

CONTACT

ΑΒΡΑΑΜ Πλούμης

CONTACT

[email protected]

+306932080701

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study 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.

Acronym: Nutristroke

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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