Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Scavenging of Reactive Carbonyl Species by Dietary Flavonoids From Soymilk, Green Tea, and Blueberry in Humans

Conditions
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Human Health, Reactive Carbonyl Species, Polyphenols

Intervention / Treatment
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* Dietary Supplement: Soymilk, green tea, or blueberry
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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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 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 Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary flavonoids (soymilk, green tea, or blueberry) consumption<br>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. | Dietary Supplement: Soymilk, green tea, or blueberry<br>* One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast.<br>|
| Placebo Comparator: Control group<br>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 Supplement: Control group<br>* Breakfast with milk or water, without soymilk, green tea, or blueberry blends.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in urine | 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, 12-24 hours post-dose | 
| 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. | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in plasma. | 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. | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in fecal samples | 0 hour, 24 hours, 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary levels of RCS over 24 hours after one single dose of soymilk, green tea, or blueberry consumption | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in urine | 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, 12-24 hours post-dose | 
| Change in plasma levels of RCS over 24 hours after one single dose of soymilk, green tea, or blueberry consumption | Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS in plasma | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary flavonoids, Pharmacokinetics, Reactive Carbonyl Species, Polyphenols