Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

North Carolina Agriculture & Technical State University48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Human Health Reactive Carbonyl Species Polyphenols

Interventions

Soymilk, green tea, or blueberryDIETARY_SUPPLEMENT

One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast.

Control groupDIETARY_SUPPLEMENT

Breakfast with milk or water, without soymilk, green tea, or blueberry blends.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 25-70 years 2. BMI between 18 and 30 3. Have no known allergy to soy milk 4. Be not taking antibiotics for six months 5. 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 6. Be nonsmoking 7. 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 8. Have no extended exposure to industrial wastes Exclusion Criteria: 1. Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders 2. Cancer patients 1. Currently diagnosed cancer patients will be excluded; 2. Medication free for \>2 years could be considered;

Locations (1)

North Carolina Agriculture and Technical State University

Kannapolis, North Carolina, United States

Outcomes

Primary Outcomes

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.

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.

Time frame: assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose

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.

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.

Time frame: assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose

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.

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.

Time frame: 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose

Secondary Outcomes

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.

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.

Data from ClinicalTrials.gov

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