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van CCT (UK)

van CCT (UK)

Nutritional status in stroke patients

- candidate number28146
- NTR NumberNTR6802
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2017
- Secondary IDsMPR16TA07987 Nutricia Research
- Public TitleNutritional status in stroke patients
- Scientific TitleNutritional status of ischaemic stroke patients in a rehabilitation phase compared to a reference group
- hypothesisThe nutritional status in the stroke rehabilitation group is unequal to nutritional status in age- and sex-matched healthy reference group.
- Healt Condition(s) or Problem(s) studiedNutritional status, Ischemic stroke, Rehabilitation patients
- Inclusion criteriaInclusion criteria patients:
1. Diagnosis of ischaemic stroke
2. Time after stroke: °› 2 and °‹ 12 weeks
3. Inpatient in a stroke rehabilitation centre
4. Age °› 50 and °‹ 75 years
5. Written informed consent

Inclusion criteria healthy subjects:
1. Body Mass Index (BMI): °› 20 and < 30 kg/m2
2. Written informed consent
- Exclusion criteriaExclusion criteria patients:
1. Diagnosis of haemorrhagic stroke
2. Known history of progressive neurological disorders (e.g. Parkinson°Įs 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°Įs 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 (°›10 cigarettes or °›5 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2017
- planned closingdate1-nov-2020
- Target number of participants0
- InterventionsNot applicable, this is an observational study
- Primary outcomeNutritional status
- Secondary outcomeDemographics, Quality of life, Activities daily living score, level of malnutrition and stroke characteristics (in patient group).
- TimepointsTime points of the outcome; Visit 0 (screening) Visit 1 (Day 7).
- Trial web site
- status[default]
- Sponsor/Initiator Danone Nutricia Research
- Funding
(Source(s) of Monetary or Material Support)
Danone Nutricia Research
- Publications
- Brief summaryThe NUST study is an observational study in which the nutritional status of ischemic stroke patients with and without dysphagia in the rehabilitation phase will be compared to healthy reference subjects.
The primary outcome parameter will be the nutritional status. The secondary outcome parameters will be demographics, subject characteristics and stroke characteristics.
The study is a multi-centre study and will be performed in Germany.
- Main changes (audit trail)
- RECORD6-nov-2017 - 25-nov-2017

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