Human Health, Polyphenols, Reactive Carbonyl Species
Conditions
Keywords
dietary flavonoids, Pharmacokinetics, Reactive Carbonyl Species, Polyphenols
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.
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.
Interventions
DIETARY_SUPPLEMENTSoymilk, green tea, or blueberry
One dose of soymilk, green tea, or blueberry blends (460mL) with breakfast.
DIETARY_SUPPLEMENTControl group
Breakfast with milk or water, without soymilk, green tea, or blueberry blends.
Sponsors
North Carolina Agriculture & Technical State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 25-70 years 2. BMI between 18 and 30 3. Have no known allergy to soy milk 4. Be not taking antibiotics for six months 5. Be not currently taking medication 1. No taking any prescription drugs 2. 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 3. No any drugs or supplements within three weeks of the experiment 6. Be nonsmoking 7. Have no alcoholic intoxication 1. No alcoholic addiction 2. \< 3-4 drinks per week (less than 2 glasses (300 mL) per drink) 3. No alcohol within 3 three weeks of the experiment 8. Have no extended exposure to industrial wastes
Exclusion criteria
1. Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, diabetes, GI disorders, or endocrine disorders 2. Cancer patients 1. Currently diagnosed cancer patients will be excluded; 2. Medication free for \>2 years could be considered;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | assessed at 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 one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS. |
| 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. | 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 one single dose of soymilk, green tea, or blueberry consumption will be quantified using LC-MS. |
| 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. | 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, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShengmin Sang, PhD
NC A&T State University
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 8 |
| 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 | 7 |
| 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 | 9 |
| 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 | 8 |
| 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 | 8 |
| Total | 48 |
Baseline characteristics
| Characteristic | Soymilk Consumption First, Then Placebo | Placebo First, Then Soymilk Consumption | Green Tea Consumption First, Then Placebo | Placebo First, Then Green Tea Consumption | Blueberry Consumption First, Then Placebo | Placebo First, Then Blueberry Consumption | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 35 years | 38.625 years | 47.857 years | 40.11 years | 41.375 years | 44.375 years | 41.0625 years |
| Body Mass Index (BMI) | 24.89 kg/m^2 | 26.76 kg/m^2 | 25.21 kg/m^2 | 23.94 kg/m^2 | 23.89 kg/m^2 | 25.25 kg/m^2 | 25 kg/m^2 |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 7 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 34 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 24 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: assessed at 0 hour, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soymilk Consumption | 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. | MGO at 1.0 h | 508.52 nM | Standard Deviation 113.9 |
| Soymilk Consumption | 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. | MGO at 0.5 h | 349.00 nM | Standard Deviation 202.39 |
| Soymilk Consumption | 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. | MGO at 0 h | 388.81 nM | Standard Deviation 194.58 |
| Soymilk Consumption | 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. | MGO at 2.0 h | 403.56 nM | Standard Deviation 142.8 |
| Soymilk Consumption | 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. | MGO at 4.0 h | 252.68 nM | Standard Deviation 117.25 |
| Soymilk Consumption | 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. | MGO at 3.0 h | 253.72 nM | Standard Deviation 317.69 |
| Soymilk Consumption | 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. | MGO at 1.5 h | 281.63 nM | Standard Deviation 99.55 |
| Placebo for Soymilk Consumption | 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. | MGO at 3.0 h | 321.49 nM | Standard Deviation 146.08 |
| Placebo for Soymilk Consumption | 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. | MGO at 2.0 h | 531.82 nM | Standard Deviation 176.33 |
| Placebo for Soymilk Consumption | 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. | MGO at 4.0 h | 347.67 nM | Standard Deviation 139.16 |
| Placebo for Soymilk Consumption | 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. | MGO at 0 h | 414.10 nM | Standard Deviation 211.59 |
| Placebo for Soymilk Consumption | 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. | MGO at 0.5 h | 579.12 nM | Standard Deviation 264.45 |
| Placebo for Soymilk Consumption | 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. | MGO at 1.0 h | 652.50 nM | Standard Deviation 182.36 |
| Placebo for Soymilk Consumption | 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. | MGO at 1.5 h | 676.58 nM | Standard Deviation 255.8 |
| Green Tea Consumption | 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. | MGO at 2.0 h | 401.58 nM | Standard Deviation 193.72 |
| Green Tea Consumption | 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. | MGO at 1.5 h | 288.82 nM | Standard Deviation 124.72 |
| Green Tea Consumption | 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. | MGO at 0 h | 265.62 nM | Standard Deviation 90.11 |
| Green Tea Consumption | 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. | MGO at 4.0 h | 322.85 nM | Standard Deviation 130.64 |
| Green Tea Consumption | 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. | MGO at 0.5 h | 235.66 nM | Standard Deviation 99.01 |
| Green Tea Consumption | 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. | MGO at 1.0 h | 397.41 nM | Standard Deviation 227.1 |
| Green Tea Consumption | 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. | MGO at 3.0 h | 326.86 nM | Standard Deviation 165.36 |
| Placebo for Green Tea Consumption | 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. | MGO at 0.5 h | 245.23 nM | Standard Deviation 125.26 |
| Placebo for Green Tea Consumption | 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. | MGO at 3.0 h | 403.98 nM | Standard Deviation 203.01 |
| Placebo for Green Tea Consumption | 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. | MGO at 1.5 h | 276.45 nM | Standard Deviation 87.94 |
| Placebo for Green Tea Consumption | 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. | MGO at 0 h | 266.84 nM | Standard Deviation 58.88 |
| Placebo for Green Tea Consumption | 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. | MGO at 2.0 h | 414.64 nM | Standard Deviation 194.55 |
| Placebo for Green Tea Consumption | 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. | MGO at 4.0 h | 342.93 nM | Standard Deviation 214.31 |
| Placebo for Green Tea Consumption | 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. | MGO at 1.0 h | 434.22 nM | Standard Deviation 197.9 |
| Blueberry Consumption | 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. | MGO at 0 h | 800.22 nM | Standard Deviation 145.41 |
| Blueberry Consumption | 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. | MGO at 3.0 h | 307.07 nM | Standard Deviation 56.13 |
| Blueberry Consumption | 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. | MGO at 0.5 h | 680.86 nM | Standard Deviation 241.39 |
| Blueberry Consumption | 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. | MGO at 4.0 h | 522.59 nM | Standard Deviation 126.55 |
| Blueberry Consumption | 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. | MGO at 1.0 h | 448.25 nM | Standard Deviation 200.51 |
| Blueberry Consumption | 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. | MGO at 1.5 h | 179.23 nM | Standard Deviation 60.95 |
| Blueberry Consumption | 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. | MGO at 2.0 h | 499.80 nM | Standard Deviation 156.25 |
| Placebo for Blueberry Consumption | 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. | MGO at 2.0 h | 478.71 nM | Standard Deviation 152.22 |
| Placebo for Blueberry Consumption | 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. | MGO at 1.5 h | 253.73 nM | Standard Deviation 190.67 |
| Placebo for Blueberry Consumption | 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. | MGO at 1.0 h | 488.45 nM | Standard Deviation 323.42 |
| Placebo for Blueberry Consumption | 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. | MGO at 3.0 h | 307.85 nM | Standard Deviation 92.04 |
| Placebo for Blueberry Consumption | 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. | MGO at 0.5 h | 542.16 nM | Standard Deviation 184.62 |
| Placebo for Blueberry Consumption | 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. | MGO at 4.0 h | 482.44 nM | Standard Deviation 191.36 |
| Placebo for Blueberry Consumption | 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. | MGO at 0 h | 783.50 nM | Standard Deviation 151.67 |
p-value: 0.016t-test, 2 sided
p-value: 0.11t-test, 2 sided
p-value: 0.59t-test, 2 sided
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.
Time frame: 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, and 12-24 hours post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soymilk Consumption | 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. | MGO-EC at 8-12 h | NA nmol/mSmo | — |
| Soymilk Consumption | 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. | MGO-EC at 4-6 h | NA nmol/mSmo | — |
| Soymilk Consumption | 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. | MGO-EC at 6-8 h | NA nmol/mSmo | — |
| Soymilk Consumption | 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. | MGO-EC at 2-4 h | NA nmol/mSmo | — |
| Soymilk Consumption | 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. | MGO-EC at 12-24 h | NA nmol/mSmo | — |
| Soymilk Consumption | 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. | MGO-EC at 0-2 h | NA nmol/mSmo | — |
| Placebo for Soymilk Consumption | 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. | MGO-EC at 8-12 h | NA nmol/mSmo | — |
| Placebo for Soymilk Consumption | 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. | MGO-EC at 0-2 h | NA nmol/mSmo | — |
| Placebo for Soymilk Consumption | 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. | MGO-EC at 4-6 h | NA nmol/mSmo | — |
| Placebo for Soymilk Consumption | 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. | MGO-EC at 6-8 h | NA nmol/mSmo | — |
| Placebo for Soymilk Consumption | 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. | MGO-EC at 12-24 h | NA nmol/mSmo | — |
| Placebo for Soymilk Consumption | 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. | MGO-EC at 2-4 h | NA nmol/mSmo | — |
| Green Tea Consumption | 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. | MGO-EC at 12-24 h | 0.0027 nmol/mSmo | Standard Deviation 0.005 |
| Green Tea Consumption | 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. | MGO-EC at 0-2 h | 0.042 nmol/mSmo | Standard Deviation 0.019 |
| Green Tea Consumption | 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. | MGO-EC at 2-4 h | 0.048 nmol/mSmo | Standard Deviation 0.021 |
| Green Tea Consumption | 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. | MGO-EC at 8-12 h | 0.011 nmol/mSmo | Standard Deviation 0.008 |
| Green Tea Consumption | 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. | MGO-EC at 6-8 h | 0.018 nmol/mSmo | Standard Deviation 0.008 |
| Green Tea Consumption | 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. | MGO-EC at 4-6 h | 0.033 nmol/mSmo | Standard Deviation 0.013 |
| Placebo for Green Tea Consumption | 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. | MGO-EC at 2-4 h | NA nmol/mSmo | — |
| Placebo for Green Tea Consumption | 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. | MGO-EC at 12-24 h | NA nmol/mSmo | — |
| Placebo for Green Tea Consumption | 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. | MGO-EC at 8-12 h | 0.0012 nmol/mSmo | Standard Deviation 0.003 |
| Placebo for Green Tea Consumption | 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. | MGO-EC at 6-8 h | NA nmol/mSmo | — |
| Placebo for Green Tea Consumption | 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. | MGO-EC at 4-6 h | NA nmol/mSmo | — |
| Placebo for Green Tea Consumption | 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. | MGO-EC at 0-2 h | NA nmol/mSmo | — |
| Blueberry Consumption | 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. | MGO-EC at 4-6 h | NA nmol/mSmo | — |
| Blueberry Consumption | 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. | MGO-EC at 2-4 h | NA nmol/mSmo | — |
| Blueberry Consumption | 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. | MGO-EC at 8-12 h | NA nmol/mSmo | — |
| Blueberry Consumption | 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. | MGO-EC at 0-2 h | NA nmol/mSmo | — |
| Blueberry Consumption | 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. | MGO-EC at 6-8 h | NA nmol/mSmo | — |
| Blueberry Consumption | 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. | MGO-EC at 12-24 h | NA nmol/mSmo | — |
| Placebo for Blueberry Consumption | 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. | MGO-EC at 0-2 h | NA nmol/mSmo | — |
| Placebo for Blueberry Consumption | 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. | MGO-EC at 12-24 h | NA nmol/mSmo | — |
| Placebo for Blueberry Consumption | 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. | MGO-EC at 2-4 h | NA nmol/mSmo | — |
| Placebo for Blueberry Consumption | 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. | MGO-EC at 8-12 h | NA nmol/mSmo | — |
| Placebo for Blueberry Consumption | 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. | MGO-EC at 6-8 h | NA nmol/mSmo | — |
| Placebo for Blueberry Consumption | 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. | MGO-EC at 4-6 h | NA nmol/mSmo | — |
p-value: 0.0196t-test, 2 sided
p-value: >0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided
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.
Time frame: assessed at 0-2 hours, 2-4 hours, 4-6 hours, and 6-8 hours post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Soymilk Consumption | 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. | MGO at 2-4 h | 4.41 nmol/mSmo | Standard Deviation 0.8 |
| Soymilk Consumption | 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. | MGO at 4-6 h | 3.37 nmol/mSmo | Standard Deviation 0.79 |
| Soymilk Consumption | 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. | MGO at 0-2 h | 3.71 nmol/mSmo | Standard Deviation 0.76 |
| Soymilk Consumption | 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. | MGO at 6-8 h | 3.23 nmol/mSmo | Standard Deviation 1.03 |
| Placebo for Soymilk Consumption | 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. | MGO at 6-8 h | 3.15 nmol/mSmo | Standard Deviation 0.69 |
| Placebo for Soymilk Consumption | 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. | MGO at 2-4 h | 3.87 nmol/mSmo | Standard Deviation 1.57 |
| Placebo for Soymilk Consumption | 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. | MGO at 4-6 h | 2.98 nmol/mSmo | Standard Deviation 0.71 |
| Placebo for Soymilk Consumption | 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. | MGO at 0-2 h | 4.70 nmol/mSmo | Standard Deviation 3.54 |
| Green Tea Consumption | 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. | MGO at 2-4 h | 4.49 nmol/mSmo | Standard Deviation 1.06 |
| Green Tea Consumption | 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. | MGO at 0-2 h | 5.01 nmol/mSmo | Standard Deviation 1.4 |
| Green Tea Consumption | 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. | MGO at 6-8 h | 4.56 nmol/mSmo | Standard Deviation 1.14 |
| Green Tea Consumption | 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. | MGO at 4-6 h | 4.41 nmol/mSmo | Standard Deviation 0.66 |
| Placebo for Green Tea Consumption | 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. | MGO at 2-4 h | 4.79 nmol/mSmo | Standard Deviation 0.63 |
| Placebo for Green Tea Consumption | 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. | MGO at 0-2 h | 4.98 nmol/mSmo | Standard Deviation 0.77 |
| Placebo for Green Tea Consumption | 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. | MGO at 6-8 h | 5.06 nmol/mSmo | Standard Deviation 1.11 |
| Placebo for Green Tea Consumption | 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. | MGO at 4-6 h | 4.60 nmol/mSmo | Standard Deviation 0.67 |
| Blueberry Consumption | 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. | MGO at 4-6 h | 5.82 nmol/mSmo | Standard Deviation 1.94 |
| Blueberry Consumption | 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. | MGO at 0-2 h | 7.38 nmol/mSmo | Standard Deviation 2.93 |
| Blueberry Consumption | 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. | MGO at 2-4 h | 7.66 nmol/mSmo | Standard Deviation 2.64 |
| Blueberry Consumption | 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. | MGO at 6-8 h | 4.77 nmol/mSmo | Standard Deviation 1.86 |
| Placebo for Blueberry Consumption | 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. | MGO at 6-8 h | 4.53 nmol/mSmo | Standard Deviation 1.17 |
| Placebo for Blueberry Consumption | 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. | MGO at 0-2 h | 8.10 nmol/mSmo | Standard Deviation 2.72 |
| Placebo for Blueberry Consumption | 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. | MGO at 2-4 h | 8.11 nmol/mSmo | Standard Deviation 2.24 |
| Placebo for Blueberry Consumption | 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. | MGO at 4-6 h | 6.52 nmol/mSmo | Standard Deviation 2.13 |
p-value: 0.968t-test, 2 sided
p-value: 0.366t-test, 2 sided
p-value: >0.05t-test, 2 sided
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.
Time frame: 0 hour, 24 hours, and 48 hours post-dose
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.
Time frame: 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