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临床试验/NCT04314739
NCT04314739已完成不适用

The Acute and Chronic Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults

Northumbria University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change from baseline concentration of biomarkers of systemic inflammation

研究概览

简要总结

Previous research has suggested that high levels of systemic inflammation can contribute to cognitive deficits and additional health problems; consumption of polyphenols have been shown to have an anti-inflammatory effect. Resveratrol, a polyphenol found primarily in red grape skins, has previously been shown to improve brain blood flow and possibly brain function and may potentially reduce systemic inflammation, however there is limited research into this.

This study will investigate the effects of 4 weeks daily consumption of resveratrol on inflammation and cognitive function in healthy adults.

详细描述

Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, this will take place in the afternoon and last 2 1/2 hours in total. During the initial visit participants will be asked to provide written informed consent. They will provide lifestyle and demographic data and screened regards to physical health (height, weight, blood pressure, waist to hip ratio). They will then complete a food frequency questionnaire and be trained on the computerised cognitive and mood tasks. Participants will also be trained on completing the cognitive assessment battery on their mobile phone, they will complete a further 5 assessments on their phone, once the day before their first visit and every 7 days during the supplementation period.

Study days 1 and 2 (4 weeks apart) :

Participants will arrive at the laboratory at an agreed time in the morning (7am, 8.30am or 10am) having fasted for 12 hours, avoided caffeinated products for 18 hours, alcohol and over the counter medication for 24 hours and oral antihistamines for 48 hours prior to the session commencing.

Participants will provide a blood sample, they will then complete a short computerised cognitive assessment (~20 minutes in length), followed by measurements of blood pressure and heart rate. Following this the participants will consume their treatment for the day, followed by a 40 minute absorption period and then will complete the second cognitive assessment. Participants will then provide a second blood sample. At the end of the first study session participants will be provided with their treatment and treatment diary, they will be instructed to take one tablet twice a day (30 minutes after breakfast and dinner). Both study visits will be identical and will take place 29 days (+/- 2 days) apart.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants must self-assess themselves as being in good health.
  • •Aged 18 to 55 at the time of giving consent

排除标准

  • •Have a Body Mass Index (BMI) outside the range of 18.5-42kg/m2

研究组 & 干预措施

Placebo

Placebo Comparator

Matched placebo capsules (1 capsule consumed at two timepoints each day).

干预措施: Placebo (Dietary Supplement)

Resveratrol

Active Comparator

500mg of Veri-te Resveratrol (consumed as two 250mg tablets, at two timepoints each day).

干预措施: Resveratrol (Dietary Supplement)

结局指标

主要结局

Change from baseline concentration of biomarkers of systemic inflammation

时间窗: 1 hour post dose; 4 weeks

Assessment of change from baseline: C reactive protein, tumor necrosis factor alpha and interleukin 6.

次要结局

  • Interim changes in cognitive task performance(Day 7; Day 14; Day 21; Day 28)
  • Chronic changes in mood(4 weeks)
  • Acute changes in concentration of plasma and serum biomarkers(1 hour post dose)
  • Changes in weight and Body Mass Index (BMI)(4 weeks)
  • Chronic changes in cognitive task performance(4 weeks)
  • Acute changes in mood(40 mins post dose)
  • Chronic changes in concentration of plasma and serum biomarkers(4 weeks)
  • Acute changes in cognitive task performance(40 minutes post dose)
  • Interim changes in mood(Day 7; Day 14; Day 21; Day 28)
  • Acute and chronic changes in heart rate(1 hour post dose, 4 weeks)
  • Acute and chronic changes in blood pressure(1 hour post dose, 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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