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临床试验/NCT06923722
NCT06923722招募中不适用

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

University of Birmingham1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
1
主要终点
Pre-frontal cortical Tissue Oxygenation Index (NIRS) - TOI

研究概览

简要总结

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.

详细描述

Psychological stress is widespread in our societies, and has been extensively shown to have negative consequences for human health. Specifically, psychological stress induces significant declines in human vascular function, as measured by brachial Flow-mediated Dilatation (FMD). We have demonstrated that flavonoid interventions can prevent the harmful effects of stress on the vascular system. Indeed, flavonoid-rich interventions have also been extensively shown to improve peripheral and cerebrovascular function in the absence of stress. However, the effect of flavonoids on cerebrovascular function and cognition in the context of mental stress is unknown. In the proposed project, our key objectives are to investigate whether grape intake prior to a mental stress task results in better brain oxygenation and vascular function, which leads to improved cognitive performance and mood in young healthy adults. These data will establish whether grapes can be effective as a 'stress snack' to optimize cognitive and brain function in the context of psychological stress. Furthermore, we will explore whether there are certain participant characteristics that mediate the impact of grape flavonoids on cerebrovascular function and cognition in the context of mental stress. Such as, physical fitness (assessed by a VO2 max test), composition of gut microbiome (assessed by faecal sample), habitual diet (assessed by 3-day food diary and the food frequency questionnaire), and eating behaviour and chronic stress (assessed by the eating behaviour questionnaire and perceived stress scale). This work will be important to guide future dietary recommendations around stress and might ultimately result in increased intake of flavonoid-rich grapes and other flavonoid-rich fruits/vegetables overall.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The interventions have been masked by the intervention supplier (California Table Grape Commission). Therefore, all researchers are blinded to the conditions.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Males and females
  • •18 - 40 years old

排除标准

  • •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

研究组 & 干预措施

High-flavonoid grape intervention

Experimental

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

干预措施: High-flavonoid grape intervention (Dietary Supplement)

Low-flavonoid grape intervention

Placebo Comparator

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

干预措施: Low-flavonoid grape intervention (Dietary Supplement)

结局指标

主要结局

Pre-frontal cortical Tissue Oxygenation Index (NIRS) - TOI

时间窗: 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.

Pre-frontal cortical Tissue Oxygenation Index (NIRS) - O2Hb

时间窗: 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).

Pre-frontal cortical Tissue Oxygenation Index (NIRS) - HHb

时间窗: 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).

Pre-frontal cortical Tissue Oxygenation Index (NIRS) - nTHI

时间窗: 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).

次要结局

  • 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).)
  • Executive Function (MANT) - Reaction time(Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).)
  • Executive Function (Switch) - Reaction time(Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).)
  • 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) - Inverse Efficiency Score(Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).)
  • Executive Function (Switch) - Inverse Efficiency Score(Change from pre-intervention baseline to 1 hour 15 minutes post-intervention (10 minutes post-stress).)
  • Mood (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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catarina Rendeiro

Principal Investigator, Assistant Professor in Nutritional Sciences

University of Birmingham

研究点 (1)

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