Trial Outcomes & Findings for Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans (NCT NCT05773794)

NCT ID: NCT05773794

Last Updated: 2025-05-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

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

Results posted on

2025-05-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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
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
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
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
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
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
Wash-in Period (1 Week)
STARTED
8
8
7
9
8
8
Wash-in Period (1 Week)
COMPLETED
8
8
7
9
8
8
Wash-in Period (1 Week)
NOT COMPLETED
0
0
0
0
0
0
First Intervention (1 Day)
STARTED
8
8
7
9
8
8
First Intervention (1 Day)
COMPLETED
8
8
7
9
8
8
First Intervention (1 Day)
NOT COMPLETED
0
0
0
0
0
0
Wash-out Period (1 Week)
STARTED
8
8
7
9
8
8
Wash-out Period (1 Week)
COMPLETED
8
8
7
9
8
8
Wash-out Period (1 Week)
NOT COMPLETED
0
0
0
0
0
0
Second Intervention (1 Day)
STARTED
8
8
7
9
8
8
Second Intervention (1 Day)
COMPLETED
8
8
7
9
8
8
Second Intervention (1 Day)
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Soymilk Consumption First, Then Placebo
n=8 Participants
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
Placebo First, Then Soymilk Consumption
n=8 Participants
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
Green Tea Consumption First, Then Placebo
n=7 Participants
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
Placebo First, Then Green Tea Consumption
n=9 Participants
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
Blueberry Consumption First, Then Placebo
n=8 Participants
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
Placebo First, Then Blueberry Consumption
n=8 Participants
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
Total
n=48 Participants
Total of all reporting groups
Age, Continuous
35 years
n=5 Participants
38.625 years
n=7 Participants
47.857 years
n=5 Participants
40.11 years
n=4 Participants
41.375 years
n=21 Participants
44.375 years
n=10 Participants
41.0625 years
n=115 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
5 Participants
n=4 Participants
4 Participants
n=21 Participants
4 Participants
n=10 Participants
24 Participants
n=115 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
4 Participants
n=7 Participants
4 Participants
n=5 Participants
4 Participants
n=4 Participants
4 Participants
n=21 Participants
4 Participants
n=10 Participants
24 Participants
n=115 Participants
Race/Ethnicity, Customized
Asian
4 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=10 Participants
13 Participants
n=115 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=10 Participants
2 Participants
n=115 Participants
Race/Ethnicity, Customized
White
4 Participants
n=5 Participants
7 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
6 Participants
n=21 Participants
6 Participants
n=10 Participants
34 Participants
n=115 Participants
Body Mass Index (BMI)
24.89 kg/m^2
n=5 Participants
26.76 kg/m^2
n=7 Participants
25.21 kg/m^2
n=5 Participants
23.94 kg/m^2
n=4 Participants
23.89 kg/m^2
n=21 Participants
25.25 kg/m^2
n=10 Participants
25 kg/m^2
n=115 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Soymilk Consumption
n=16 Participants
Participants consumed 460 mL of soymilk in a single dose. The analysis is to assess the levels of major RCS (MGO) and their major conjugates of polyphenols in human urine.
Placebo for Soymilk Consumption
n=16 Participants
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.
Green Tea Consumption
n=16 Participants
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.
Placebo for Green Tea Consumption
n=16 Participants
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.
Blueberry Consumption
n=16 Participants
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.
Placebo for Blueberry Consumption
n=16 Participants
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.
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 0.80
3.87 nmol/mSmo
Standard Deviation 1.57
4.49 nmol/mSmo
Standard Deviation 1.06
4.79 nmol/mSmo
Standard Deviation 0.63
7.66 nmol/mSmo
Standard Deviation 2.64
8.11 nmol/mSmo
Standard Deviation 2.24
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
2.98 nmol/mSmo
Standard Deviation 0.71
4.41 nmol/mSmo
Standard Deviation 0.66
4.60 nmol/mSmo
Standard Deviation 0.67
5.82 nmol/mSmo
Standard Deviation 1.94
6.52 nmol/mSmo
Standard Deviation 2.13
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
3.15 nmol/mSmo
Standard Deviation 0.69
4.56 nmol/mSmo
Standard Deviation 1.14
5.06 nmol/mSmo
Standard Deviation 1.11
4.77 nmol/mSmo
Standard Deviation 1.86
4.53 nmol/mSmo
Standard Deviation 1.17
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
4.70 nmol/mSmo
Standard Deviation 3.54
5.01 nmol/mSmo
Standard Deviation 1.40
4.98 nmol/mSmo
Standard Deviation 0.77
7.38 nmol/mSmo
Standard Deviation 2.93
8.10 nmol/mSmo
Standard Deviation 2.72

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Soymilk Consumption
n=16 Participants
Participants consumed 460 mL of soymilk in a single dose. The analysis is to assess the levels of major RCS (MGO) and their major conjugates of polyphenols in human urine.
Placebo for Soymilk Consumption
n=16 Participants
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.
Green Tea Consumption
n=16 Participants
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.
Placebo for Green Tea Consumption
n=16 Participants
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.
Blueberry Consumption
n=16 Participants
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.
Placebo for Blueberry Consumption
n=16 Participants
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.
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
414.10 nM
Standard Deviation 211.59
265.62 nM
Standard Deviation 90.11
266.84 nM
Standard Deviation 58.88
800.22 nM
Standard Deviation 145.41
783.50 nM
Standard Deviation 151.67
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
579.12 nM
Standard Deviation 264.45
235.66 nM
Standard Deviation 99.01
245.23 nM
Standard Deviation 125.26
680.86 nM
Standard Deviation 241.39
542.16 nM
Standard Deviation 184.62
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 113.90
652.50 nM
Standard Deviation 182.36
397.41 nM
Standard Deviation 227.10
434.22 nM
Standard Deviation 197.90
448.25 nM
Standard Deviation 200.51
488.45 nM
Standard Deviation 323.42
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
676.58 nM
Standard Deviation 255.80
288.82 nM
Standard Deviation 124.72
276.45 nM
Standard Deviation 87.94
179.23 nM
Standard Deviation 60.95
253.73 nM
Standard Deviation 190.67
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 142.80
531.82 nM
Standard Deviation 176.33
401.58 nM
Standard Deviation 193.72
414.64 nM
Standard Deviation 194.55
499.80 nM
Standard Deviation 156.25
478.71 nM
Standard Deviation 152.22
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
321.49 nM
Standard Deviation 146.08
326.86 nM
Standard Deviation 165.36
403.98 nM
Standard Deviation 203.01
307.07 nM
Standard Deviation 56.13
307.85 nM
Standard Deviation 92.04
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
347.67 nM
Standard Deviation 139.16
322.85 nM
Standard Deviation 130.64
342.93 nM
Standard Deviation 214.31
522.59 nM
Standard Deviation 126.55
482.44 nM
Standard Deviation 191.36

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Soymilk Consumption
n=16 Participants
Participants consumed 460 mL of soymilk in a single dose. The analysis is to assess the levels of major RCS (MGO) and their major conjugates of polyphenols in human urine.
Placebo for Soymilk Consumption
n=16 Participants
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.
Green Tea Consumption
n=16 Participants
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.
Placebo for Green Tea Consumption
n=16 Participants
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.
Blueberry Consumption
n=16 Participants
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.
Placebo for Blueberry Consumption
n=16 Participants
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.
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
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
0.042 nmol/mSmo
Standard Deviation 0.019
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
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
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
0.048 nmol/mSmo
Standard Deviation 0.021
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
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
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
0.033 nmol/mSmo
Standard Deviation 0.013
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
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
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
0.018 nmol/mSmo
Standard Deviation 0.008
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
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
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
0.011 nmol/mSmo
Standard Deviation 0.008
0.0012 nmol/mSmo
Standard Deviation 0.003
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
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
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
0.0027 nmol/mSmo
Standard Deviation 0.005
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.
NA nmol/mSmo
Standard Deviation NA
The data is below the lower limit of detection and unable to be quantified.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Soymilk Consumption

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo for Soymilk Consumption

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Green Tea Consumption

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo for Green Tea Consumption

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Blueberry Consumption

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo for Blueberry Consumption

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shengmin Sang

North Carolina A&T State University

Phone: 7042505710

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place