Trial Outcomes & Findings for Comparing the Effect of Whey and Soy Protein on the Absorption of Pomegranate Polyphenols in the Human Body (NCT NCT02233478)
NCT ID: NCT02233478
Last Updated: 2019-09-19
Results Overview
Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.
COMPLETED
NA
18 participants
Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period
2019-09-19
Participant Flow
The enrollment period was 08/01/2014 - 01/31/2015. Enrollment took place in a private setting in the clinic located at the site.
After a 4-day washout period, participants received pomegranate juice (PJ) alone, PJ mixed with soy protein, or PJ mixed with soybean flour in random sequence with a 7-day washout in between.
Participant milestones
| Measure |
PJ First, Then PJ With Soybean Flour, Then PJ With Soy Protein
Participants consumed PJ alone, then PJ+ soybean flour, then PJ + soy protein with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
|
PJ First, Then PJ With Soy Protein, Then PJ With Soybean Flour
Participants consumed PJ alone, then PJ+ soy protein, then PJ + soybean flour with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
|
PJ With Soybean Flour First, Then PJ, Then PJ With Soy Protein
Participants consumed PJ+soybean flour, then PJ alone, then PJ+soy protein with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
|
PJ With Soybean Flour First, Then PJ With Soy Protein, Then PJ
Participants consumed PJ+soybean flour, then PJ+soy protein, then PJ alone with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
|
PJ With Soy Protein First, Then PJ With Soybean Flour, Then PJ
Participants consumed PJ+soy protein, then PJ+soybean flour, then PJ alone with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
|
PJ With Soy Protein First, Then PJ, Then PJ With Soybean Flour
Participants consumed PJ+soy protein, then PJ alone, then PJ+soybean flour with PJ dosing 236.5 mL, soy protein 20 g and soybean flour 20 g
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention (1 Day)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout (7 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Intervention (1 Day)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (1 Day)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Intervention (1 Day)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Third Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Effect of Whey and Soy Protein on the Absorption of Pomegranate Polyphenols in the Human Body
Baseline characteristics by cohort
| Measure |
All Study Participants
n=18 Participants
Participants took pomegranate juice (PJ, 236.5 mL or 8 fl.oz) alone, or PJ (236.5 mL) mixed with 20 g of soy protein, or PJ (236.5 mL) mixed with 20 g of soybean flour in random order.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
|
BMI
|
26.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week periodPopulation: All participants for whom plasma ellagic acid was determined at baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of PJ, or PJ with soy protein, or PJ with soybean flour
Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.
Outcome measures
| Measure |
All Study Participants Consuming PJ
n=18 Participants
Participants consumed PJ (236.5 mL) only
|
All Study Participants Comsuming PJ With Soy Protein
n=18 Participants
Participants consumed PJ (236.5 mL) mixed with soy protein isolate (20 g)
|
All Study Participants Comsuming PJ With Soybean Flour
Participants consumed PJ (236.5 mL) with soybean flour protein (20 g)
|
|---|---|---|---|
|
Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve
|
0.074 micromol*h/L
Standard Deviation 0.029
|
0.075 micromol*h/L
Standard Deviation 0.028
|
—
|
Adverse Events
Study Participants Consuming PJ Alone
Study Participants Consuming PJ With Soy Protein
Study Participants Consuming PJ With Soybean Flour
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zhaoping Li, Professor
Center for Human Nutrition, Department of Medicine, UCLA David Geffen School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place