An interventional study of Soymilk and Control Group in Human Health, Reactive Carbonyl Species and Polyphenols, sponsored by North Carolina Agriculture & Technical State University. Completed at 1 site in United States. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by North Carolina Agriculture & Technical State University · Not applicable, Interventional, and Treatment
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.
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.
North Carolina Agriculture & Technical State University is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have no known allergy to soy milk
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Be not currently taking medication
No taking any prescription drugs
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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
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Have no alcoholic intoxication
No alcoholic addiction
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\< 3-4 drinks per week (less than 2 glasses (300 mL) per drink)
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Exclusion Criteria:
Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
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Cancer patients
Currently diagnosed cancer patients will be excluded;
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Soymilk
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.
Dietary Supplement: Control Group
Participants consumed a breakfast with 460 mL of soymilk in a single dose.
Participants consumed a breakfast with 460 mL of diary milk in a single dose.
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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: Pooled plasma from 0.5, 1.0, 1.5, 2.0, and 4 hours post-dose.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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North Carolina Agriculture & Technical State University