De-stressing the Brain: Can Eating Grapes During Periods of Mental Stress Protect Brain and Vascular Health in Young Adults
A Placebo-controlled, Randomized, Double-masked, Cross-over Acute Intervention Study Investigating the Effects of Grape Polyphenols on Cerebral Oxygenation, Cognitive and Vascular Function in the Context of Mental Stress in Young Adults
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B15 2TT
- Recruiting
- School of Sport, Exercise & Rehabilitation Sciences
-
Contact:
- Catarina Rendeiro
- Phone Number: +44 7389190669
- Email: c.rendeiro@bham.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and females
- 18 - 40 years old
Exclusion Criteria:
- Smokers
- Consumes > 21 units of alcohol per week
- History of cardiovascular, respiratory, metabolic, liver or inflammatory diseases
- Suffers from blood-clotting disorders
- Allergies or intolerances to foods
- On a weight reducing dietary regiment
- Currently taking dietary supplements, including fatty acids and vitamins
- On long-term medication or have been on antibiotics in the last 3 months
- Has an infection at present (e.g. cold) or viral infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: High-flavonoid grape intervention
60 g freeze-dried grape powder, equivalent to 300 g fresh grapes (Total polyphenols: 437 mg/100g)
|
High-flavonoid grape powder: 60 g, equivalent to 300 g fresh grapes.
Total polyphenols: 437 mg/100g).
|
|
Placebo Comparator: Low-flavonoid grape intervention
60 g powder isocaloric-matched control (Total polyphenols: < 60 mg)
|
60 g powder isocaloric-matched control (Total polyphenols: < 60 mg)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-frontal cortical Tissue Oxygenation Index (NIRS) - TOI
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress)
|
Pre-frontal levels of Tissue Oxygenation Index (% TOI) will be assessed by functional Near-Infrared Spectroscopy (fNIRS).
The NIRS device measures changes in chromophore concentrations of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb), providing depth-resolved measures of total tissue oxygen saturation.
|
Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress)
|
|
Pre-frontal cortical Tissue Oxygenation Index (NIRS) - O2Hb
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress).
|
Pre-frontal levels of oxygenated (O2Hb) haemoglobin concentration (μmol) will be assessed by functional Near-Infrared Spectroscopy (fNIRS).
|
Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress).
|
|
Pre-frontal cortical Tissue Oxygenation Index (NIRS) - HHb
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress).
|
Pre-frontal levels of deoxygenated (HHb) haemoglobin concentration (μmol) will be assessed by functional Near-Infrared Spectroscopy (fNIRS).
|
Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress).
|
|
Pre-frontal cortical Tissue Oxygenation Index (NIRS) - nTHI
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress).
|
Pre-frontal levels of normalised haemoglobin index (relative value of total haemoglobin normalised to the initial value, nTHI) content (a.u.) will be assessed by functional Near-Infrared Spectroscopy (fNIRS).
|
Change from pre-intervention baseline to 1 hour post-intervention (during mental stress) and 1 hour 15 minutes post-intervention (during cognitive tasks, 10 minutes post-stress).
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flow-mediated dilatation (FMD) of the brachial artery
Time Frame: Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
FMD of the brachial artery.
Expressed as % FMD: change in brachial diameter from baseline to peak dilation following 5 minutes of arterial occlusion.
Brachial artery diameter and blood flow will be measured using Doppler ultrasonography (uSmart 3300, Terason).
|
Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
|
Common Carotid Artery (CCA) - Blood flow
Time Frame: Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
Common Carotid Artery (CCA) blood flow velocity (ml min-1) will be measured using Doppler ultrasonography (uSmart 3300, Terason) interfaced with the Quipu analysis software.
CCA blood flow is calculated using CCA blood velocity and diameter across 2 minutes of recording.
|
Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
|
Common Carotid Artery (CCA) - Shear rate
Time Frame: Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
Common Carotid Artery (CCA) shear rate (s-1) will be measured using Doppler ultrasonography (uSmart 3300, Terason) interfaced with the Quipu analysis software.
|
Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
|
Executive Function (MANT) - Accuracy
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
Executive function accuracy will be measured using the Modified Attention Network Task (MANT) which measures response to cognitive load
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
|
Executive Function (Switch) - Accuracy
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
Executive function accuracy will be measured using the Switch Task which considers cognitive flexibility.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
|
Executive Function (MANT) - Reaction time
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
Executive function reaction time will be measured using Modified Attention Network Task (MANT) which measures response to cognitive load.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
|
Executive Function (Switch) - Reaction time
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
Executive function reaction time will be measured using the Switch Task which considers cognitive flexibility.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
|
Executive Function (MANT) - Inverse Efficiency Score
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
Executive function inverse efficiency will be measured using the Modified Attention Network Task (MANT), calculated by dividing task reaction time by task accuracy.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
|
Executive Function (Switch) - Inverse Efficiency Score
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
Executive function inverse efficiency will be measured using the Switch Task, calculated by dividing task reaction time by task accuracy.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
|
|
Mood (POMS)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (immediately following stress), 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
Mood (total mood disturbance, TMD) will be assessed by the questionnaire Profile-of-Mood-States (POMS).
|
Change from pre-intervention baseline to 1 hour post-intervention (immediately following stress), 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forearm blood flow (FBF)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Venous occlusion plethysmography will assess the forearm vasodilatory response (ml/100ml/min) to mental stress.
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Forearm vascular conductance (FVC)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Forearm vascular conductance (FVC) will be calculated by dividing FBF by beat-to-beat mean arterial pressure (MAP).
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Cardiovascular activity - Heart rate (HR)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Heart rate (HR, bpm) is assessed using an electrocardiogram.
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Cardiovascular activity - R-wave to pulse interval (RPI)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
R-wave to pulse interval (RPI, ms) is assessed using an electrocardiogram, to provide an indication of sympathetic activity.
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Cardiovascular activity - Heart rate variability (HRV)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Heart rate variability (HRV, ms) is assessed using an electrocardiogram, to provide an indication of parasympathetic activity.
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Cardiovascular activity - beat-to-beat systolic blood pressure (SBP)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Beat-to-beat systolic blood pressure (SBP) will be measured using a Finometer (mmHg).
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Cardiovascular activity - beat-to-beat diastolic blood pressure (DBP)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Beat-to-beat diastolic blood pressure (SBP) will be measured using a Finometer (mmHg).
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Cardiovascular activity - beat-to-beat mean arterial pressure (MAP)
Time Frame: Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
Beat-to-beat mean arterial pressure (MAP) will be measured using a Finometer (mmHg).
|
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
|
|
Brachial Systolic Blood Pressure (SBP)
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress), 2 hours post-intervention (45 minutes post-stress) and 2 hour 45 minutes post-intervention (90 minutes post-stress).
|
Resting systolic blood pressure (mmHg) will be measured using an automated oscillometric blood pressure monitor, with a cuff attached to the right upper arm, following at least 10 minutes rest.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress), 2 hours post-intervention (45 minutes post-stress) and 2 hour 45 minutes post-intervention (90 minutes post-stress).
|
|
Brachial Diastolic Blood Pressure (DBP)
Time Frame: Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress), 2 hours post-intervention (45 minutes post-stress) and 2 hour 45 minutes post-intervention (90 minutes post-stress).
|
Resting diastolic blood pressure (mmHg) will be measured using an automated oscillometric blood pressure monitor, with a cuff attached to the right upper arm, following at least 10 minutes rest.
|
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress), 2 hours post-intervention (45 minutes post-stress) and 2 hour 45 minutes post-intervention (90 minutes post-stress).
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ERN_17-1755H
- 3155902 (Other Grant/Funding Number: California Table Grape Comission)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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