Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

Not Applicable

Completed

Conditions: Reactive Carbonyl Species
Human Health
Polyphenols

Interventions: Dietary Supplement: Control group
Dietary Supplement: Soymilk, green tea, or blueberry

Registration Number: NCT05773794

Lead Sponsor: North Carolina Agriculture & Technical State University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

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
1. No taking any prescription drugs
2. 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
3. No any drugs or supplements within three weeks of the experiment
Be nonsmoking
Have no alcoholic intoxication
1. No alcoholic addiction
2. < 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
3. No alcohol within 3 three weeks of the experiment
Have no extended exposure to industrial wastes

Exclusion Criteria

Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
Cancer patients
1. Currently diagnosed cancer patients will be excluded;
2. Medication free for >2 years could be considered;

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Each subject takes breakfast with 460 ml of milk or water in a single dose, and samples (plasma, urine, and stool samples) at different time points were collected following the administration of milk or water.
Dietary flavonoids (soymilk, green tea, or blueberry) consumption	Soymilk, green tea, or blueberry	Each subject takes breakfast with 460 ml of soymilk, green tea, or blueberry in a single dose, and samples (plasma, urine, and stool samples) at different time points were collected following the administrations of soymilk, green tea, or blueberry blend.

Primary Outcome Measures

Name	Time	Method
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.	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.	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.	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.

Secondary Outcome Measures

Name	Time	Method
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	Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in plasma over 24 hours after one single dose of soymilk, green tea, or blueberry consumption.
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	Major RCS adducts in fecal samples after soymilk, green tea, or blueberry consumption will be profiled. Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in fecal samples.