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

NCT06961825 | Not Yet Recruiting

• 1 other identifier: University of Ioannina
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

protein supplementation; nutritional intervention; albumin levels; stroke; stroke rehabilitation; eating disorders; malnutrition; nutritional assessment; sarcopenia; osteopenia

Outcome Measures

Primary Outcomes (1)

• Serum Albumin Levels

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

  Baseline and every 2 weeks for up to 6 weeks

Secondary Outcomes (1)

• Muscle Mass (Whole-body DEXA)

  Baseline and at week 6

Study Arms (3)

Protein Supplement - Single Dose

EXPERIMENTAL

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

Dietary Supplement: Dietary Supplement

Protein Supplement - Double Dose

EXPERIMENTAL

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

Dietary Supplement: Dietary Supplement

Control group

NO INTERVENTION

no protein supplementation

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

Protein Supplement - Double Dose; Protein Supplement - Single Dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece, 4500, Greece

Location

MeSH Terms

Conditions

Stroke; Hypoalbuminemia; Sarcopenia; Bone Diseases, Metabolic; Malnutrition; Protein-Energy Malnutrition; Feeding and Eating Disorders

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Protein Deficiency; Deficiency Diseases; Signs and Symptoms, Digestive; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Avraam Ploumis

  University Hospital, Ioannina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ΑΒΡΑΑΜ Πλούμης

CONTACT

+306932080701; aploumis@uoi.gr

Avraam Ploumis

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan Professor of PMR,Orthopaedic Spine Surgeon

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 5, 2030
• Study Completion (Estimated): May 5, 2030
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)