Human HealthNCT07874360
Scavenging of Reactive Carbonyl Species by Soymilk in Humans
A study testing Soymilk in people with Human Health and Reactive Carbonyl Species, run by North Carolina Agriculture & Technical State University at 1 site in United States.
Trial summary
This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of soymilk polyphenols 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
- Conditions the study is for
- Human Health, Reactive Carbonyl Species, Polyphenols
- What is being tested?
- Soymilk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Show all 19Show fewer
- 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 LipoFlavonoid 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
About this study
This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of soymilk polyphenols in humans after a single dose of dietary flavonoids.
Read the detailed description
A crossover design was used. Sixteen healthy volunteers were recruited and asked to avoid the consumption of any soymilk starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.
On week 2, eight participants consumed breakfast with 460 mL of soymilk in a single dose (group I), 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 with 460 mL of diary milk in a single dose (group II), 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.
On the contrary, on week 3, two groups crossed over. 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.
- Conditions
- Human Health, Reactive Carbonyl Species, Polyphenols
- Being tested
- Soymilk, 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.
SoymilkDietary supplement
Participants consumed a breakfast with 460 mL of soymilk in a single dose.
Control GroupDietary supplement
Participants consumed a breakfast with 460 mL of diary milk in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Soymilk consumption | Experimental | Participants consumed a breakfast with 460 mL of 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 |
| Control group | Placebo comparator | Participants consumed a breakfast with 460 mL of diary 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. Receives: Dietary Supplement: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Levels of Reactive Carbonyl Species (RCS) Over 8 Hours After a Single Soymilk Intake.
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 a single dose of soymilk consumption will be quantified using LC-MS.
Measured: assessed at 0 hour, 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose.
Plasma Levels of Reactive Carbonyl Species (RCS) Over 4 Hours After a Single Soymilk Intake.
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 a single dose of soymilk 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.
Urinary Levels of Catechin-RCS Conjugates Over 24 Hours After a Single Soymilk Intake
Major RCS conjugates of polyphenols in urine after soymilk consumption will be profiled using liquid chromatographytandem mass spectrometry (LC-MS). The levels of major RCS conjugates in urine over 24 h after soymilk consumption will be quantified using LC-MS.
Measured: 0 hour, 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose.
Secondary outcomes (1)
Qualitative Identification of Plasma Isoflavone-RCS Conjugates After a Single Soymilk Intake.
Liquid chromatography-tandem mass spectrometry was used to qualitatively identify Isoflavone-RCS conjugates in pooled plasma samples collected from 0.5 to 4 hours after a single soymilk intake.
Measured: Pooled plasma from 0.5, 1.0, 1.5, 2.0, and 4 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start6 Feb 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina Agriculture & Technical State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengmin Sang, North Carolina Agriculture & Technical State University
- Investigators
- Shengmin Sang, PhD, Principal investigator, NC A&T State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874360
- Sponsor's protocol ID
- 22-0093S
- Status last verified
- May 2025
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scavenging of Reactive Carbonyl Species by Soymilk in Humans
- ClinicalTrials.gov ID
- NCT07874360
- Acronym / sponsor ID
- 22-0093S
- Conditions
- Human Health, Reactive Carbonyl Species, Polyphenols
- Keywords
- dietary flavonoids, Pharmacokinetics, Reactive Carbonyl Species, Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- North Carolina Agriculture & Technical State UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study to investigate the formation and pharmacokinetics of reactive carbonyl species adducts of soymilk polyphenols in humans after a single dose of dietary flavonoids.
Detailed description
A crossover design was used. Sixteen healthy volunteers were recruited and asked to avoid the consumption of any soymilk starting 1 week before intervention and continuing throughout the entire study for a total of 3 weeks.
On week 2, eight participants consumed breakfast with 460 mL of soymilk in a single dose (group I), 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 with 460 mL of diary milk in a single dose (group II), 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.
On the contrary, on week 3, two groups crossed over. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soymilk consumption | Experimental | Dietary Supplement: SoymilkParticipants consumed a breakfast with 460 mL of 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. |
| Control group | Placebo comparator | Dietary Supplement: Control GroupParticipants consumed a breakfast with 460 mL of diary 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 25-70 years -
- BMI between 18 and 30 -
- Have no known allergy to soy milk
- -
- Be not taking antibiotics for six months -
Key exclusion criteria (6 listed)
- Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
- -
- Cancer patients
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoymilkParticipants consumed a breakfast with 460 mL of soymilk in a single dose. | Dietary supplement | Soymilk consumption |
| Control GroupParticipants consumed a breakfast with 460 mL of diary milk in a single dose. | Dietary supplement | Control group |
Primary outcome
Urinary Levels of Reactive Carbonyl Species (RCS) Over 8 Hours After a Single Soymilk Intake.
Time frame: assessed at 0 hour, 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose.
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 a single dose of soymilk consumption will be quantified using LC-MS.
Plasma Levels of Reactive Carbonyl Species (RCS) Over 4 Hours After a Single Soymilk Intake.
Time frame: assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose.
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 a single dose of soymilk consumption will be quantified using LC-MS.
Urinary Levels of Catechin-RCS Conjugates Over 24 Hours After a Single Soymilk Intake
Time frame: 0 hour, 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose.
Major RCS conjugates of polyphenols in urine after soymilk consumption will be profiled using liquid chromatographytandem mass spectrometry (LC-MS). The levels of major RCS conjugates in urine over 24 h after soymilk consumption will be quantified using LC-MS.
1 secondary outcome
Qualitative Identification of Plasma Isoflavone-RCS Conjugates After a Single Soymilk Intake.
Time frame: Pooled plasma from 0.5, 1.0, 1.5, 2.0, and 4 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Human Health
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
Human Papillomavirus Infection
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Not yet recruiting
Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention
MCI, Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengmin Sang, PhD principal investigator
NC A&T State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soymilk 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 19 inclusion and 6 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 14 Oct 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary Levels of Reactive Carbonyl Species (RCS) Over 8 Hours After a Single Soymilk Intake. (time frame: assessed at 0 hour, 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 14 Oct 2026.