Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

Polyphenols Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773794
• Other study ID #: 22-0093
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: March 2024
• Source: North Carolina Agriculture & Technical State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Human Health
• Polyphenols

Intervention

Dietary Supplement:
• Soymilk, green tea, or blueberry
One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast.
• Control group
Breakfast with milk or water, without soymilk, green tea, or blueberry blends.

Locations

Country	Name	City	State
United States	North Carolina Agriculture and Technical State University	Kannapolis	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
North Carolina Agriculture & Technical State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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
Primary	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
Primary	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	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
Secondary	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