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
2 other identifiers
interventional
44
1 country
1
Brief Summary
The main aim of the current study is to investigate whether consuming grapes rich in flavonoids just before mental stress can protect cerebrovascular and peripheral vascular function, mood and cognition, from the negative effects of mental stress in young healthy adults. A second, exploratory aim, will further address whether quality of habitual diet, microbiome health (composition; metabolites production e.g. Short-chain fatty acids) and levels of cardiorespiratory fitness play a role on the beneficial effects of grapes during mental stress. All participants will receive a high-flavonoid grape intervention (60 g freeze-dried grape powder, equivalent to 300 g fresh grapes) and a low-flavonoid grape intervention (60 g powdere isocaloric-matched control). It is hypothesized that the high-flavonoid grape intervention will improve cortical oxygenation and cognitive function in the context of mental stress, and prevent the stress-induced decline in peripheral endothelial function following stress. Furthermore, it is hypothesized that individuals with poorer diets, cardiorespiratory fitness and a poorer gut microbiome will benefit more from the grape intervention in the context of mental stress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Apr 2025
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedDecember 4, 2025
December 1, 2025
12 months
March 27, 2025
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pre-frontal cortical Tissue Oxygenation Index (NIRS) - TOI
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
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
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
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 Outcomes (10)
Flow-mediated dilatation (FMD) of the brachial artery
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
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
Change from pre-intervention baseline to 2 hours and 2 hours 45 minutes post-intervention (45-90 minutes post-stress).
Executive Function (MANT) - Accuracy
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
Executive Function (Switch) - Accuracy
Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).
- +5 more secondary outcomes
Other Outcomes (10)
Forearm blood flow (FBF)
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
Forearm vascular conductance (FVC)
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)
Change from pre-intervention baseline to 1 hour post-intervention (during 8 minutes rest and 8 minutes of mental stress).
- +7 more other outcomes
Study Arms (2)
High-flavonoid grape intervention
EXPERIMENTAL60 g freeze-dried grape powder, equivalent to 300 g fresh grapes (Total polyphenols: 437 mg/100g)
Low-flavonoid grape intervention
PLACEBO COMPARATOR60 g powder isocaloric-matched control (Total polyphenols: \< 60 mg)
Interventions
High-flavonoid grape powder: 60 g, equivalent to 300 g fresh grapes. Total polyphenols: 437 mg/100g).
60 g powder isocaloric-matched control (Total polyphenols: \< 60 mg)
Eligibility Criteria
You may qualify if:
- Males and females
- years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Birminghamlead
- California Table Grape Commissioncollaborator
Study Sites (1)
School of Sport, Exercise & Rehabilitation Sciences
Birmingham, West Midlands, B15 2TT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The interventions have been masked by the intervention supplier (California Table Grape Commission). Therefore, all researchers are blinded to the conditions.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Assistant Professor in Nutritional Sciences
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 11, 2025
Study Start
April 1, 2025
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
December 4, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share