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Human HealthNCT05773794

Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

A study testing Soymilk, green tea, or blueberry in people with Human Health and Reactive Carbonyl Species, run by North Carolina Agriculture & Technical State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 70 yearsHealthy volunteers can take part
What is being tested?
Soymilk, green tea, or blueberry
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
6 Feb 2023to 19 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

United States1 site
  • North Carolina Agriculture and Technical State University

    Kannapolis, North Carolina, 28081

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Soymilk, green tea, or blueberry, Control group
Keywords
dietary flavonoids, Pharmacokinetics, Reactive Carbonyl Species, Polyphenols

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soymilk, green tea, or blueberryDietary supplement

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

  • Control groupDietary supplement

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

Study groups in NCT05773794
Study groupRoleWhat they receive
Dietary flavonoids (soymilk) consumptionExperimentalWeek 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.
Receives: Dietary Supplement: Soymilk, green tea, or blueberry; Dietary Supplement: Control group
Dietary flavonoids (blueberry) consumptionExperimentalWeek 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.
Receives: Dietary Supplement: Soymilk, green tea, or blueberry; Dietary Supplement: Control group
Dietary flavonoids (green tea) consumptionExperimentalWeek 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.
Receives: Dietary Supplement: Soymilk, green tea, or blueberry; Dietary Supplement: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (2)
  1. 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.

    Major RCS adducts in fecal samples after soymilk, green tea, or blueberry consumption will be profiled. Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in fecal samples.

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

  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.

    Liquid chromatography-tandem mass spectrometry will be utilized to assess RCS adducts of soymilk, green tea, or blueberry polyphenols in plasma over 24 hours after one single dose of soymilk, green tea, or blueberry consumption.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start6 Feb 2023
  3. Primary completion19 Dec 2023
  4. Study completion19 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773794
Sponsor's protocol ID
22-0093
Status last verified
May 2025
First submitted
23 Feb 2023
Last updated
2 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Soymilk, green tea, or blueberry in people with Human Health and Reactive Carbonyl Species, run by North Carolina Agriculture & Technical State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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