NCT06923722

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2025

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

March 27, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

vascular functionflavonoidscerebral oxygenationmental stresscognitionexecutive functiongrapeFlow-mediated dilatationFunctional Near-Infrared Spectroscopy

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

EXPERIMENTAL

60 g freeze-dried grape powder, equivalent to 300 g fresh grapes (Total polyphenols: 437 mg/100g)

Dietary Supplement: High-flavonoid grape intervention

Low-flavonoid grape intervention

PLACEBO COMPARATOR

60 g powder isocaloric-matched control (Total polyphenols: \< 60 mg)

Dietary Supplement: Low-flavonoid grape intervention

Interventions

High-flavonoid grape powder: 60 g, equivalent to 300 g fresh grapes. Total polyphenols: 437 mg/100g).

High-flavonoid grape intervention

60 g powder isocaloric-matched control (Total polyphenols: \< 60 mg)

Low-flavonoid grape intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

School of Sport, Exercise & Rehabilitation Sciences

Birmingham, West Midlands, B15 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

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

Locations