Effects of Flavonoids on Cognitive Performance in Healthy Young Adults
22. november 2011 opdateret af: Jeremy Paul Edward Spencer, University of Reading
The purpose of this study is to investigate changes in cerebral blood flow, blood flavonoid levels, brain-derived neurotrophic factor, vascular reactivity and cognitive performance in young adults as a result of acute administration of a fruit-derived flavonoid-rich or flavonoid-poor drink.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
There has recently been an increasing interest in the potential of flavonoids, plant derived compounds found in foods such as fruit and vegetables, to ameliorate age-related cognitive decline.
Research suggests that flavonoids improve memory and learning, possibly as a result of their anti-oxidant, anti-inflammatory and neuroprotective effects for example by increasing cerebral blood flow, protecting vulnerable neurons, enhancing existing neuronal function or by stimulating neuronal function.
The research will initially involve a randomised cross-over human dietary intervention trial using two flavonoid-rich drinks (flavanone-rich and flavanone-poor) to investigate changes in cerebral blood flow in young adults (n=6; age range 18-30 years).
Changes in cognitive performance and measures of serum BDNF levels will then be investigated in a second randomised cross-over trial using the intervention drink showing the greatest effect on cerebral blood flow in young adults (n=24; age range 18-30 years) and using a range of sensitive tests of executive function.
The study is designed to measure acute effects of types of flavonoid supplementation and, as well as the primary cognitive outcome, will assess flavonoid/metabolite and BDNF (brain-derived neurotrophic factor) levels in blood and changes in vascular reactivity.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Berkshire
-
Reading, Berkshire, Det Forenede Kongerige, RG6 6AP
- University of Reading
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 30 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- MMSE between 26 and 30
- 18-30 years of age
- Native or good English speaker
- Normal BMI/body fat composition
- No significant vision, hearing or language problems
- Able to consume the beverages
Exclusion Criteria:
- Any form of disease/major mental illness/chronic fatigue syndrome
- On medication for hypertension/elevated lipids/diabetes
- On medication known to impact endothelial function
- Gall bladder/gastrointestinal abnormalities
- Sensitivity to orange or apple
- High consumer of fruit, vegetables, fruit beverages
- High consumer of caffeine or alcohol
- Consumer of illegal substances
- Vegetarian/vegan/other dieter/vigorous exerciser
- Use of antibiotics in the previous 8 weeks
- Consumer of dietary supplements
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Fruit beverage
|
500ml fruit juice beverage, single dose per visit
Andre navne:
|
|
Eksperimentel: Control beverage
|
500ml fruit juice beverage, single dose per visit
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Executive function
Tidsramme: change in attention between baseline and 2h
|
45-minute computer-based test battery of executive function tasks administered twice per visit day, at 0 hours (baseline) and 2 hours post-intervention.
Visit days are at least one week apart.
|
change in attention between baseline and 2h
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cerebral blood flow
Tidsramme: change in attention between baseline and 2h
|
Non-invasive fMRI (arterial spin labelling) is conducted pre- and post-intervention at 3 time-points: 0 (baseline), and 2 and 5 hours post-intervention on 3 study days at least one week apart
|
change in attention between baseline and 2h
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2010
Primær færdiggørelse (Faktiske)
1. august 2011
Studieafslutning (Faktiske)
1. september 2011
Datoer for studieregistrering
Først indsendt
9. marts 2011
Først indsendt, der opfyldte QC-kriterier
9. marts 2011
Først opslået (Skøn)
10. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. november 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. november 2011
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UReading-2011-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .