Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
University Hospital of Ioannina
Ioannina, Greece, Greece
Start Date
May 5, 2025
Primary Completion Date
May 5, 2030
Completion Date
May 5, 2030
Last Updated
May 8, 2025
100
ESTIMATED participants
Dietary Supplement
DIETARY_SUPPLEMENT
Avraam Ploumis
CONTACT
Lead Sponsor
University of Ioannina
NCT07371455
NCT05093673
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06258538