Scavenging of Reactive Carbonyl Species by Dietary Flavonoids From Soymilk, Green Tea, and Blueberry in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Urinary Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 8 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.
研究概览
简要总结
This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of dietary polyphenols (soymilk, green tea, and blueberry) in humans after a single dose of dietary flavonoids.
详细描述
A crossover design was used. Sixteen healthy volunteers (16 for each study, in total 48) were recruited and asked to avoid the consumption of any soymilk, green tea, and blueberry products starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.
On week 2, each of the eight participants received 460 ml of soymilk, green tea, and blueberry in a single dose, and afterward, urine and blood samples at different time points over 24 h and fecal samples at different time points over 48 h were collected. Meanwhile, the other eight participants received breakfast (without any soymilk, green tea, and blueberry) at different time points over 48 h were collected.
On the contrary, on week 3, eight participants who received regular milk or water on week 2 received breakfast only, and eight participants who were used as a control on week 2 received soymilk, green tea, and blueberry. And urine and blood samples at different time points over 24 h, and fecal samples at different time points over 48 h for both groups were collected.
Samples will be analyzed by LC-MS/MS. The Pharmacokinetics of conjugates will be investigated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-70 years
- •BMI between 18 and 30
- •Have no known allergy to soy milk
- •Be not taking antibiotics for six months
- •Be not currently taking medication
- •No taking any prescription drugs
- •If supplements were taken, flavonoid-enriched supplements (see list below) should be avoided.
- •Major brands Notes: All flavonoid-enriched supplements should be avoided. Soy Isoflavones/ tea/blueberry Lipo-Flavonoid Citrus Bioflavonoids Complex Super Flavonoids Super Antioxidants Quercetin Supplement Essential-C and flavonoids Milk Thistle Other flavonoids supplements, including but not limited: Luteolin, Rutin, etc
- •No any drugs or supplements within three weeks of the experiment
- •Be nonsmoking
- •Have no alcoholic intoxication
- •No alcoholic addiction
- •< 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
- •No alcohol within 3 three weeks of the experiment
- •Have no extended exposure to industrial wastes
排除标准
- •Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
- •Cancer patients
- •Currently diagnosed cancer patients will be excluded;
- •Medication free for >2 years could be considered;
研究组 & 干预措施
Dietary flavonoids (soymilk) consumption
Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.
Week 2: Participants consumed a breakfast including 460 mL of soymilk (or milk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
Week 3: Participants consumed a breakfast including 460 mL of milk (or soymilk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
干预措施: Soymilk, green tea, or blueberry (Dietary Supplement)
Dietary flavonoids (soymilk) consumption
Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.
Week 2: Participants consumed a breakfast including 460 mL of soymilk (or milk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
Week 3: Participants consumed a breakfast including 460 mL of milk (or soymilk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
干预措施: Control group (Dietary Supplement)
Dietary flavonoids (blueberry) consumption
Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.
Week 2: Participants consumed a breakfast including 460 mL of blueberry water (or placebo sweet water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
Week 3: Participants consumed a breakfast including 460 mL of placebo sweet water (or blueberry water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
干预措施: Soymilk, green tea, or blueberry (Dietary Supplement)
Dietary flavonoids (blueberry) consumption
Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.
Week 2: Participants consumed a breakfast including 460 mL of blueberry water (or placebo sweet water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
Week 3: Participants consumed a breakfast including 460 mL of placebo sweet water (or blueberry water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
干预措施: Control group (Dietary Supplement)
Dietary flavonoids (green tea) consumption
Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.
Week 2: Participants consumed a breakfast including 460 mL of green tea (or water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
Week 3: Participants consumed a breakfast including 460 mL of water (or green tea) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
干预措施: Soymilk, green tea, or blueberry (Dietary Supplement)
Dietary flavonoids (green tea) consumption
Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.
Week 2: Participants consumed a breakfast including 460 mL of green tea (or water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
Week 3: Participants consumed a breakfast including 460 mL of water (or green tea) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Change in Urinary Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 8 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.
时间窗: assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose
Major RCS in urine will be outlined using Liquid chromatography-tandem mass spectrometry (LC-MS). The urinary levels of major RCS over 8 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.
Change in Plasma Levels of Reactive Carbonyl Species (RCS) of Soymilk, Green Tea, or Blueberry Over 4 Hours After One Single Dose of Soymilk, Green Tea, or Blueberry Consumption.
时间窗: assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose
Major RCS in plasma will be outlined using liquid chromatography-tandem mass spectrometry (LC-MS). The major RCS levels in plasma over 4 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.
Change in Urinary Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.
时间窗: 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose
Major RCS conjugates of polyphenols in urine after soymilk, green tea, or blueberry consumption will be profiled using liquid chromatography-tandem mass spectrometry (LC-MS). The levels of major RCS conjugates in urine over 24 h after soymilk, green tea, or blueberry consumption will be quantified using LC-MS.
次要结局
- Change in Plasma Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols Over 24 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.(0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 24 hours pose dose)
- Change in Levels of Reactive Carbonyl Species (RCS) Adducts of Soymilk, Green Tea, or Blueberry Polyphenols in Feces Over 48 Hours After One Single Dose of Soymilk, Green Tea, or Consumption.(0 hour, 24 hours, and 48 hours post-dose)
研究者
Shengmin Sang
Distinguished Professor
North Carolina Agriculture & Technical State University