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临床试验/NCT06144489
NCT06144489已完成不适用

Plasma-Induced Changes in the Metabolome Following Polyphenol Consumption

Northumbria University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年3月31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
12
试验地点
2
主要终点
Processes, Metabolic

研究概览

简要总结

The goal of this clinical trial is to compare the changes in the human metabolome following a low or high acute dose of European tart cherries. The main question it aims to answer is:

what effect do European tart cherries have on the human metabolome?

Participants will attend the laboratory at the university on 3 separate occasions. Take a 3 different supplements: a placebo, low or high dose of European tart cherry supplement. Have venous blood samples taken as baseline, then 1, 2, 3, 5 and 8 h post ingestion of the supplement. Researchers will compare placebo, low and high to see if changes the human metabolome.

详细描述

Participants Twelve healthy participants (nine male and three female) were recruited for this study; the mean ± SD age, stature, mass and body mass index (BMI) were 29 ± 7 years old, 174.8 ± 9.3 cm, 77.29 ± 10.52 kg and 25.23 ± 1.87 kg/m2, respectively. All participants were healthy, as assessed by a health-screening questionnaire and provided written, informed consent. Exclusion criteria for the study were as follows: food allergy (as discussed with research team), history of gastrointestinal, renal, cardiovascular or thyroid disease and current use of any food supplementations. This study received ethical approval from Northumbria University Ethics Committee (reference number: 39904) (clinical trial tbc).

Experimental Design The study utilised a double blind, three-arm cross-over, pseudo-randomised (counter-balanced to eliminate order effects) design in order to identify metabolomic shifts following the acute ingestion of a low dose (LOW), high dose (HI) of TC or placebo (CON). A washout period of at least 7 days (but not greater than 21 days) between each phase was implemented. Participants were required to attend the start of each phase of the study at 7:45 am following a 10 h overnight fast in order to account for diurnal variation (Figure 1). Upon arrival to the lab, the participants baseline blood pressure (BP) was recorded in a rested state (following at least 5 mins of sitting), then cannulated for serial blood sampling. A standardized breakfast was then provided. Subsequent measures were then taken at baseline, 1, 2, 3, 5 and 8 hrs post-VTC consumption. Water was provided ad-libitum, but no additional food was given during testing visits.

Treatments and Dietary Control The low (LOW) and high (HI) dose consisted of 3 or 6 g of the TC supplement (CherryCraft), respectively, or a 3g capsule placebo (CON) matched for caloric content using maltodextrin. The low TC dose provided approximately 60-78 mg of anthocyanins, 8.07 kcal and had a macronutrient content of 1.215 g, 0.003 g, 0.042 g, for carbohydrates, fat and protein, respectively. The high TC dose provided approximately 120-156 mg of anthocyanins, 16.14 kcal with 2.43 g, 0.006 g, 0.08 g for carbohydrates, fat and protein, respectively.

Participants were requested to follow their habitual diet throughout the trial. Food diaries were completed for the 24 hrs before each testing visit to replicate (as close to) prior to testing on following testing visits. The standardized breakfast consisted of white toast (2 slices of Sainsbury's medium white bread) and butter (approx. 16g of Bertolli/Vitalite (a vegan alternative, matched as closely as possible for calories and macronutrient content)). Participants were given water to drink ad-libitum throughout the testing visits, this was measured and refilled from baseline, and 1, 2, 3, 5 and 8 hrs post breakfast and supplement ingestion.

Blood Pressure Monitoring Blood pressure was monitored throughout the testing visits, immediately upon arrival to the lab and, 1, 2, 3, 5 and 8 hrs following ingestion of the supplement.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • fit and healthy, and not currently taking any prescription medication, anti-inflammatory, anti-oxidant supplementation in the last 3 months

排除标准

  • history of gastrointestinal, renal and/or cardiovascular disease, as well as any thyroid issues.
  • allergies
  • needle/blood phobia

研究组 & 干预措施

Placebo

Placebo Comparator

Matched with the active low dose, this placebo was matched for calorific content.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Processes, Metabolic

时间窗: up to 8 hours

Using untargeted plasma analysis, metabolite characterisations are performed on a LCMS.

次要结局

未报告次要终点

研究者

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

Glyn Howatson

Professor Glyn Howatson

Northumbria University

研究点 (2)

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