Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

NCT05773794 | Completed Results

• 1 other identifier: 22-0093
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Health; Reactive Carbonyl Species; Polyphenols

Keywords

dietary flavonoids; Pharmacokinetics; Reactive Carbonyl Species; Polyphenols

Outcome Measures

Primary Outcomes (3)

• 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.

  Major RCS in urine will be outlined using Liquid chromatography-tandem mass spectrometry (LC-MS). The urinary levels of major RCS over 8 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.

  assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose

• 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.

  Major RCS in plasma will be outlined using liquid chromatography-tandem mass spectrometry (LC-MS). The major RCS levels in plasma over 4 h after one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS.

  assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose

• 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.

  Major RCS conjugates of polyphenols in urine after soymilk, green tea, or blueberry consumption will be profiled using liquid chromatography-tandem mass spectrometry (LC-MS). The levels of major RCS conjugates in urine over 24 h after soymilk, green tea, or blueberry consumption will be quantified using LC-MS.

  0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose

Secondary Outcomes (2)

• 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.

  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.

  0 hour, 24 hours, and 48 hours post-dose

Study Arms (3)

Dietary flavonoids (soymilk) consumption

EXPERIMENTAL

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.

Dietary Supplement: Soymilk, green tea, or blueberry; Dietary Supplement: Control group

Dietary flavonoids (blueberry) consumption

EXPERIMENTAL

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.

Dietary Supplement: Soymilk, green tea, or blueberry; Dietary Supplement: Control group

Dietary flavonoids (green tea) consumption

EXPERIMENTAL

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.

Dietary Supplement: Soymilk, green tea, or blueberry; Dietary Supplement: Control group

Interventions

Soymilk, green tea, or blueberry DIETARY_SUPPLEMENT

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

Dietary flavonoids (blueberry) consumption; Dietary flavonoids (green tea) consumption; Dietary flavonoids (soymilk) consumption

Control group DIETARY_SUPPLEMENT

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

Dietary flavonoids (blueberry) consumption; Dietary flavonoids (green tea) consumption; Dietary flavonoids (soymilk) consumption

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• North Carolina Agriculture & Technical State University: lead

Study Sites (1)

North Carolina Agriculture and Technical State University

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Interventions

Tea; Control Groups

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

N/A. We successfully enrolled 16 participants for each of the three proposed PK studies, with no dropouts during the trials.

Results Point of Contact

• Title: Dr. Shengmin Sang
• Organization: North Carolina A&T State University

ssang@ncat.edu

7042505710

Study Officials

• Shengmin Sang, PhD

  NC A&T State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 17, 2023
• Study Start: February 6, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)