search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Neuro-cognitive effects of tyrosine supplementation in healthy older adults: A fNIRS-EEG study


- candidate number22023
- NTR NumberNTR5206
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2015
- Secondary IDs2015-1556 NL52264.091.15
- Public TitleNeuro-cognitive effects of tyrosine supplementation in healthy older adults: A fNIRS-EEG study
- Scientific TitleNeuro-cognitive effects of tyrosine supplementation in healthy older adults: A fNIRS-EEG study
- ACRONYMINTENSE
- hypothesisWe aim to assess the effects of tyrosine supplementation on prefrontal brain activation, as measured by a combination of fNIRS and EEG, during response inhibition and working-memory performance in older adults. We will also assess whether neuropsychological functioning – as measured by paper and pencil tests – will improve due to tyrosine supplementation.
- Healt Condition(s) or Problem(s) studiedAged, EEG, Working Memory, Cerebral blood flow
- Inclusion criteria- Aged 60-75 years
- Right-handed
- Dutch speaking
- Normal or corrected to normal vision
- Willing to comply with study procedures
- Exclusion criteria- Mini-Mental State Examination (MMSE) score of <24 (Folstein et al. 1975)
- Estimated IQ of <85 (based on Nederlandse Leestest voor Volwassenen (NLV) -score) (Schmand et al. 1991)
- Hospital Anxiety and Depression Scale score of >11 (Bjelland et al. 2002)
- Current or past psychiatric disorder, such as psychosis or major depression
- Current or past neurological disorder, such as severe cerebral vascular disease (e.g. cortical stroke, subarachnoid hemorrhage), Parkinson’s disease, epilepsy, traumatic brain injury, central nervous system infection, brain tumor, and alcoholic encephalopathy. N.B. Transient Ischaemic Attack, lacunar infarction and white matter lesions are no exclusion criteria.
- Current severe systemic disease such as coronary artery disease, myocardial infarction < 6 months, heart failure (unstable), chronic obstructive pulmonary disease (unstable)
- Current endocrine or metabolic disorders such as hepatic or renal problems
- First degree family history of schizophrenia, bipolar disorder or major depressive disorder
- Thyroid problems, such as hyperthyroidism, subclinical hyperthyroidism (TSH <0.4 mU/L), hypothyroidism, thyroid cancer.
- Using medication that can interfere with tyrosine’s action: monoamine oxidase inhibitors and other antidepressants, sympathomimetic amines, and opioids
- Following a low-protein diet as prescribed by a dietician or physician
- Use of tyrosine supplements within one month prior to visit
- Being allergic or having a dislike to the product carrier (banana-flavored yoghurt)
- Blood pressure <90/60 mmHg or >160/90 mmHg (use of antihypertensives are allowed)
- General medical conditions, such as repetitive strain injury (RSI), colorblindness or sensori-motor handicaps, which may confound the results of the study, as judged by the investigator
- Alcohol consumption of more than 14 (women) or 21 (men) units per week
- Habitual smoking, defined as more than a pack of cigarettes per week
- Current participation in another study, or a specific cognitive training study within the past six months, or a study using the same cognitive paradigm as the current study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate31-dec-2015
- Target number of participants32
- Interventions- A single dose of 150 mg/kg body weight of L-tyrosine powder
- A placebo, consisting of ~50 mg/kg body weight of dextrin-maltose and ~100 mg/kg body weight of cornstarch Both mixed with banana-flavoured yoghurt in a ratio of 1:20
- Primary outcomeChanges in functional prefrontal activation as determined by oxygenated hemoglobin changes (ėmol/L) induced by tyrosine supplementation, measured during response inhibition performance
- Secondary outcome- Changes in functional prefrontal activation as determined by oxygenated hemoglobin changes (ėmol/L) induced by tyrosine supplementation, measured during working memory performance.
- Changes in functional prefrontal activation as determined by deoxygenated hemoglobin changes (ėmol/L) induced by tyrosine supplementation, measured during response inhibition performance and working memory performance.
- Changes in brain activity as determined by EEG frequency bands, induced by tyrosine supplementation, measured during response inhibition performance.
- Timepoints2
- Trial web sitehttp://voedingsonderzoek.wur.nl/intense
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr Ondine van de Rest
- CONTACT for SCIENTIFIC QUERIESDr Ondine van de Rest
- Sponsor/Initiator Wageningen University, Division of Human Nutrition
- Funding
(Source(s) of Monetary or Material Support)
EFRO, Provincie Gelderland
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-apr-2015 - 4-aug-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl