Nutritional status after an ischemic stroke in patients in a rehabilitation centre.
Conditions
Interventions
Sponsors
Danone Nutricia Research
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria patients: 1. Diagnosis of ischaemic stroke 2. Time after stroke: ¡Ý 2 and ¡Ü 12 weeks 3. Inpatient in a stroke rehabilitation centre 4. Age ¡Ý 50 and ¡Ü 75 years 5. Written informed consent Inclusion criteria healthy subjects: 1. Body Mass Index (BMI): ¡Ý 20 and < 30 kg/m2 2. Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria patients: 1. Diagnosis of haemorrhagic stroke 2. Known history of progressive neurological disorders (e.g. Parkinson¡¯s disease, MS) 3. Dysphagia not related to stroke 4. Receiving chemo- or radiotherapy within 1 year prior to entry into the study 5. Receiving tube feeding or has been receiving tube feeding within 2 weeks prior to entry into the study 6. Current prescription of vitamin injection 7. Investigator¡¯s uncertainty about the ability to adhere to the protocol requirements because of the condition of the patient 8. Participation in any other study involving investigational or marketed products within 6 weeks prior to entry into the study Exclusion criteria healthy subjects: 1. Having a special diet, e.g. receiving oral nutritional support or tube feed, or having a dysphagia-adapted diet, vegan diet or ketogenic diet 2. Known diabetes mellitus type 2 3. Known disorders of the GI tract, including coeliac disease 4. Known history of cardiovascular or cerebrovascular disease, e.g. myocard infarct, stroke or transient ischaemic attack 5. Use of anti-hypertensive or cholesterol- or triglyceride-lowering drugs 6. Hospital admittance (with overnight stay) within 6 months prior to entry into the study 7. Receiving chemo- or radiotherapy within 1 year prior to entry into the study 8. Decrease in appetite and/or food intake within 4 weeks prior to entry into the study 9. Known weight loss of >3 kg in the last 3 months 10. Participation in weight loss diet within 3 months prior to entry into the study 11. Current moderate or heavy alcohol use (>14 consumptions per week for females or >21 consumptions per week for males), moderate or heavy smoking (¡Ý10 cigarettes or ¡Ý5 cigars/pipes per day) or drug abuse to the opinion of the investigator 12. Blood donation within 4 weeks prior to entry into the study 13. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 14. Participation in any other clinical study involving investigational or marketed products within 6 weeks prior to entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutritional status | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographics, Quality of life, Activities daily living score, level of malnutrition and stroke characteristics (in patient group). | — |
Contacts
Public ContactPeter Horssen, van
Outcome results
None listed