- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02202629
Plant Based Extracts and Cognition (CEOPTB)
28 juli 2014 uppdaterad av: PepsiCo Global R&D
The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans
Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the effect of different combinations of plant based extracts on cognitive function and cerebral blood flow.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The objectives of this study are to assess the effects of oral consumption of three differing combinations of plant based extracts, on cognitive function and cerebral blood flow (using Near infrared Spectroscopy) in comparison to placebo.
The primary outcome will be change in cognitive function and mental fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post- consumption.
Studietyp
Interventionell
Inskrivning (Förväntat)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Newcastle upon Tyne, Storbritannien, NE1 8ST
- Northumbria University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 49 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Are over 18 or under 49 years of age
- Self-report of good health
- Are not excluded on the basis of the following exclusion criteria
- English is first language (some of the cognitive tests have only been validated in native English speakers)
Exclusion Criteria:
- Are below 18 or above 49 years of age
- Are a smoker
- Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- Currently take medication except the contraceptive pill
- Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
- Have sleep disturbances and/or are taking sleep aid medication
- Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
- Have a current diagnosis of anxiety or depression
- Are pregnant, trying to get pregnant or breast feeding
- Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
- Are (or are seeking to become) pregnant or are lactating
- Have learning difficulties, dyslexia or colour blindness
- Have visual impairment that cannot be corrected with glasses or contact lenses
- Have frequent migraines that require medication (more than or equal to 1 per month)
- Have disorders of the blood
- Have a heart disorder or a history of vascular illness
- Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
- Have type I or type II diabetes
- Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
- Have any health condition that would prevent fulfillment of the study requirements
- Are currently or have in the past 4 weeks participated in other clinical or nutrition intervention studies
- Do not have a bank account (required for payment)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Cherry flavoured beverage 1
10floz cherry flavoured test article
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Experimentell: Cherry flavoured beverage 2
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
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Intervention involves single exposure, oral consumption of test article following baseline measurements
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Experimentell: Cherry flavoured beverage 3
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
|
Intervention involves single exposure, oral consumption of test article following baseline measurements
|
|
Experimentell: Cherry flavoured beverage 4
10floz of cherry flavoured test article with fruit, vegetable and herbal extracts
|
Intervention involves single exposure, oral consumption of test article following baseline measurements
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention.
Tidsram: 1-6 hours post intervention
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1-6 hours post intervention
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in executive function at 1, 3 and 6 hours post intervention.
Tidsram: 1-6 hours post intervention
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1-6 hours post intervention
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Change in cerebral blood flow parameters (oxygenated and deoxygenated haemoglobin levels and their sum) in the frontal cortex during task performance commencing at 1, 3 and 6 hours post-intervention.
Tidsram: 1-6 hours post intervention
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1-6 hours post intervention
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Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention.
Tidsram: 1-6 hours post intervention
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1-6 hours post intervention
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Change in mood ratings, at 1,3 and 6 hours post intervention.
Tidsram: 1-6 hours post intervention
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1-6 hours post intervention
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2014
Primärt slutförande (Förväntat)
1 december 2014
Studieregistreringsdatum
Först inskickad
24 juli 2014
Först inskickad som uppfyllde QC-kriterierna
28 juli 2014
Första postat (Uppskatta)
29 juli 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 juli 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2014
Senast verifierad
1 juli 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PEP-1406
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .