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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soymilk, green tea, or blueberry | Dietary Supplement | One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
Have no extended exposure to industrial wastes
Exclusion Criteria:
Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders
Cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Shengmin Sang, PhD | NC A&T State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Agriculture and Technical State University | Kannapolis | North Carolina | 28081 | United States |
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All participants were asked to avoid the consumption of any soymilk, green tea, and blueberry products one week before the study and continuing throughout the entire study except of the intervention days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Soymilk Consumption First, Then Placebo | Eight participants consumed 460 mL of soymilk in a single dose on the first intervention and 460 ml of 2% reduced fat milk in a single dose on the second intervention |
| FG001 | Placebo First, Then Soymilk Consumption | Eight participants consumed 460 ml of 2% reduced fat milk in a single dose on the first intervention and 460 ml of soymilk in a single dose on the second intervention |
| FG002 | Green Tea Consumption First, Then Placebo | Seven participants consumed 460 mL of green tea made from 2 servings (4 g) in a single dose on the first intervention and 460 ml water in a single dose on the second intervention |
| FG003 | Placebo First, Then Green Tea Consumption | Nine participants consumed 460 ml water in a single dose on the first intervention and 460 mL of green tea made from 2 servings (4 g) in a single dose on the second intervention |
| FG004 | Blueberry Consumption First, Then Placebo | Eight participants consumed 460 mL of blueberry powder (50 g) in water in a single dose on the first intervention and 460 ml blueberry powder placebo (50 g) in water in a single dose on the second intervention |
| FG005 | Placebo First, Then Blueberry Consumption | Eight participants consumed 460 mL of blueberry powder placebo (50 g) in water in a single dose on the first intervention and 460 mL of blueberry powder (50 g) in water in a single dose on the second intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wash-in period (1 week) |
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| First intervention (1 day) |
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| Wash-out period (1 week) |
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| Second intervention (1 day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Soymilk Consumption First, Then Placebo | Eight participants consumed 460 mL of soymilk in a single dose on the first intervention and 460 mL of 2% reduced fat milk in a single dose on the second intervention |
| BG001 | Placebo First, Then Soymilk Consumption |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | nmol/mSmo | assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose |
|
17 days for each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soymilk Consumption | Participants consumed 460 mL of soymilk in a single dose. |
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N/A. We successfully enrolled 16 participants for each of the three proposed PK studies, with no dropouts during the trials.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shengmin Sang | North Carolina A&T State University | 7042505710 | ssang@ncat.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 15, 2023 | Apr 3, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013662 | Tea |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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|
| Control group | Dietary Supplement | Breakfast with milk or water, without soymilk, green tea, or blueberry blends. |
|
| 0 hour, 24 hours, and 48 hours post-dose |
| 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. | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Eight participants consumed 460 mL of 2% reduced fat milk in a single dose on the first intervention and 460 mL of soymilk in a single dose on the second intervention |
| BG002 | Green Tea Consumption First, Then Placebo | Seven participants consumed 460 mL of green tea made from two servings (4 g) in a single dose on the first intervention and 460 mL of water in a single dose on the second intervention |
| BG003 | Placebo First, Then Green Tea Consumption | Nine participants consumed 460 mL of water in a single dose on the first intervention and 460 mL of green tea made from two servings (4 g) in a single dose on the second intervention |
| BG004 | Blueberry Consumption First, Then Placebo | Eight participants consumed 460 mL of blueberry powder (50 g) in water in a single dose on the first intervention and 460 mL of blueberry powder placebo (50 g) in water in a single dose on the second intervention |
| BG005 | Placebo First, Then Blueberry Consumption | Eight participants consumed 460 mL of blueberry powder placebo (50 g) in water in a single dose on the first intervention and 460 mL of blueberry powder (50 g) in water in a single dose on the second intervention |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
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Participants consumed 460 ml of 2% reduced fat milk in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine. |
| OG002 | Green Tea Consumption | Participants consumed 460 ml of green tea from two serving bags in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine. |
| OG003 | Placebo for Green Tea Consumption | Participants consumed 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine. |
| OG004 | Blueberry Consumption | Participants consumed 50 g of blueberry powder in 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine. |
| OG005 | Placebo for Blueberry Consumption | Participants consumed 50 g of blueberry powder placebo in 460 ml water in a single dose. The analysis is to assess the levels of MGO (one of the reactive carbonyl species, RCS) and its major conjugates of polyphenols in human urine. |
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|
|
| Primary | 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. | Posted | Mean | Standard Deviation | nM | assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose |
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|
| Primary | 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. | Posted | Mean | Standard Deviation | nmol/mSmo | 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose |
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| Secondary | 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. | Posted | Apr 2026 | Mean | Standard Deviation | ug/g | 0 hour, 24 hours, and 48 hours post-dose |
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| Secondary | 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. | Posted | Apr 2026 | Mean | Standard Deviation | nM | 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 |
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|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Placebo for Soymilk Consumption | Participants consumed 460 mL of 2% reduced fat milk in a single dose. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Green Tea Consumption | Participants consumed 460 ml of green tea made from 2 servings (4 g) in a single dose. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Placebo for Green Tea Consumption | Participants consumed 460 ml of water in a single dose. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG004 | Blueberry Consumption | Participants consumed 460 ml of blueberry powder (50 g) in water in a single dose. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG005 | Placebo for Blueberry Consumption | Participants consumed 460 ml of blueberry powder placebo (50 g) in water in a single dose. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| MGO at 0.5 h |
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| MGO at 1.0 h |
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| MGO at 1.5 h |
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| MGO at 2.0 h |
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| MGO at 3.0 h |
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| MGO at 4.0 h |
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| Superiority |
| t-test, 2 sided | 0.59 | Superiority |
| MGO-EC at 2-4 h |
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| MGO-EC at 4-6 h |
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| MGO-EC at 6-8 h |
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| MGO-EC at 8-12 h |
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| MGO-EC at 12-24 h |
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| Superiority |
| t-test, 2 sided | >0.05 | Superiority |
| polyphenol-MGO-24h |
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| polyphenol-MGO-48h |
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| polyphenol-MGO-0.5h |
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| polyphenol-MGO-1h |
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| polyphenol-MGO-1.5h |
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| polyphenol-MGO-2h |
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| polyphenol-MGO-3h |
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| polyphenol-MGO-4h |
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| polyphenol-MGO-6h |
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| polyphenol-MGO-8h |
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| polyphenol-MGO-24h |
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