Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

NCT ID: NCT05773794

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2023-12-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dietary flavonoids (soymilk) consumption

Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.

Week 2: Participants consumed a breakfast including 460 mL of soymilk (or milk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.

Week 3: Participants consumed a breakfast including 460 mL of milk (or soymilk) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.

Group Type: EXPERIMENTAL

Soymilk, green tea, or blueberry

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary flavonoids (blueberry) consumption

Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.

Week 2: Participants consumed a breakfast including 460 mL of blueberry water (or placebo sweet water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.

Week 3: Participants consumed a breakfast including 460 mL of placebo sweet water (or blueberry water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.

Group Type: EXPERIMENTAL

Soymilk, green tea, or blueberry

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary flavonoids (green tea) consumption

Week 1: Sixteen healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and blueberry products starting one week before the intervention and continuing throughout the entire 3-week study period.

Week 2: Participants consumed a breakfast including 460 mL of green tea (or water) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.

Week 3: Participants consumed a breakfast including 460 mL of water (or green tea) in a single dose. Urine and blood samples were collected at multiple time points over 24 hours, and fecal samples were collected at different time points over 48 hours.

Group Type: EXPERIMENTAL

Soymilk, green tea, or blueberry

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Soymilk, green tea, or blueberry

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

Intervention Type: DIETARY_SUPPLEMENT

Control group

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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;

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Carolina Agriculture & Technical State University

OTHER

Sponsor Role: lead

Responsible Party

Shengmin Sang

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shengmin Sang, PhD

Role: PRINCIPAL_INVESTIGATOR

NC A&T State University

Locations

North Carolina Agriculture and Technical State University

Kannapolis, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

22-0093

Identifier Type: -

Identifier Source: org_study_id