N/A
N=48
Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans
Human Health · Reactive Carbonyl Species · Polyphenols
Bottom Line
View on ClinicalTrials.gov: NCT05773794 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: 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. — 3.71; 4.70; 5.01; 4.98 nmol/mSmo — p=0.968
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soymilk, green tea, or blueberry (Dietary_supplement); Control group (Dietary_supplement)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- North Carolina Agriculture & Technical State University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
3.71; 4.70; 5.01; 4.98; 7.38; 8.10 | 0.968 |
| PRIMARY 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. |
388.81; 414.10; 265.62; 266.84; 800.22; 783.50 | 0.016 sig |
| PRIMARY 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. |
NA; NA; 0.042; NA; NA; NA | 0.0196 sig |
| SECONDARY 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. |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY 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. |
NA; NA; NA; NA; NA; NA | — |
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.
Eligibility Criteria
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
- 2 years could be considered;
Data sourced from ClinicalTrials.gov (NCT05773794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.