NCT05773794

Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: North Carolina Agriculture & Technical State University · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Health
• Reactive Carbonyl Species
• Polyphenols

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soymilk, green tea, or blueberry	One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast.
DIETARY_SUPPLEMENT	Control group	Breakfast with milk or water, without soymilk, green tea, or blueberry blends.

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2023-03-17
• Last updated: 2025-05-25
• Results posted: 2025-05-25

Locations

1 site across 1 country: United States