StrokeNutristrokeNCT06961825
Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.
A study testing Dietary Supplement in people with Stroke and Hypoalbuminemia, run by University of Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Hypoalbuminemia, Sarcopenia
- What is being tested?
- Dietary Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 5 May 2025to 5 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Avraam Ploumis contact
About this study
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.
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
- Being tested
- Dietary Supplement
- Keywords
- protein supplementation, nutritional intervention, albumin levels, stroke, stroke rehabilitation, eating disorders, malnutrition, nutritional assessment, sarcopenia, osteopenia
- Medical subject headings
- Stroke, Hypoalbuminemia, Sarcopenia, Bone Diseases, Metabolic, Malnutrition, Protein-Energy Malnutrition, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Protein Supplement - Single Dose | Experimental | Participants in this arm will receive one dose of protein supplement daily. Receives: Dietary Supplement: Dietary Supplement |
| Protein Supplement - Double Dose | Experimental | Participants in this arm will receive two doses of protein supplement daily. Receives: Dietary Supplement: Dietary Supplement |
| Control group | No intervention | no protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin Levels
Change in serum albumin concentration to assess nutritional status and response to protein supplementation.
Measured: Baseline and every 2 weeks for up to 6 weeks
Secondary outcomes (1)
Muscle Mass (Whole-body DEXA)
Evaluation of changes in muscle mass using DEXA scan.
Measured: Baseline and at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 May 2025 (estimated)
- Primary completion5 May 2030 (estimated)
- Study completion5 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
- Investigators
- Avraam Ploumis, Principal investigator, University Hospital, Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961825
- Sponsor's protocol ID
- University of Ioannina
- Acronym
- Nutristroke
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06961825
- Acronym / sponsor ID
- Nutristroke / University of Ioannina
- Conditions
- Stroke, Hypoalbuminemia, Sarcopenia, Osteopenia, Malnutrition (Calorie), Protein-energy Malnutrition
- Keywords
- protein supplementation, nutritional intervention, albumin levels, stroke, stroke rehabilitation, eating disorders, malnutrition, nutritional assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 5 May 2030 (estimated)
- Study completion
- 5 May 2030 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Protein Supplement - Single Dose | Experimental | Dietary Supplement: Dietary SupplementParticipants in this arm will receive one dose of protein supplement daily. |
| Protein Supplement - Double Dose | Experimental | Dietary Supplement: Dietary SupplementParticipants in this arm will receive two doses of protein supplement daily. |
| Control group | No intervention | –no protein supplementation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplementcomplete, 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 | Dietary supplement | Protein Supplement - Double Dose, Protein Supplement - Single Dose |
Primary outcome
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.
1 secondary outcome
Muscle Mass (Whole-body DEXA)
Time frame: Baseline and at week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avraam Ploumis contact
Avraam Ploumis principal investigator
University Hospital, Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with Stroke and Hypoalbuminemia, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ΑΒΡΑΑΜ Πλούμης (+306932080701, aploumis@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Albumin Levels (time frame: Baseline and every 2 weeks for up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.