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Trial record 93 of 727 for:    Area Under Curve AND Bioavailability

Comparing the Effect of Whey and Soy Protein on the Absorption of Pomegranate Polyphenols in the Human Body

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ClinicalTrials.gov Identifier: NCT02233478
Recruitment Status : Completed
First Posted : September 8, 2014
Results First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Condition Healthy
Interventions Dietary Supplement: Pomegranate Juice
Dietary Supplement: Soybean Flour Protein
Dietary Supplement: Soy Isolate Protein
Enrollment 18
Recruitment Details The enrollment period was 08/01/2014 - 01/31/2015. Enrollment took place in a private setting in the clinic located at the site.
Pre-assignment Details 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.
Arm/Group Title PJ First, Then PJ With Soybean Flour, Then PJ With Soy Protein PJ First, Then PJ With Soy Protein, Then PJ With Soybean Flour PJ With Soybean Flour First, Then PJ, Then PJ With Soy Protein PJ With Soybean Flour First, Then PJ With Soy Protein, Then PJ PJ With Soy Protein First, Then PJ With Soybean Flour, Then PJ PJ With Soy Protein First, Then PJ, Then PJ With Soybean Flour
Hide Arm/Group Description 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 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 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 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 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 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
Period Title: First Intervention (1 Day)
Started 3 3 3 3 3 3
Completed 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0
Period Title: Washout (7 Days)
Started 3 3 3 3 3 3
Completed 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0
Period Title: Second Intervention (1 Day)
Started 3 3 3 3 3 3
Completed 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0
Period Title: Washout (7 Days)
Started 3 3 3 3 3 3
Completed 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0
Period Title: Third Intervention (1 Day)
Started 3 3 3 3 3 3
Completed 3 3 3 3 3 3
Not Completed 0 0 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Since this was a crossover study, the total number of participants was 18 in each arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
31.1  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
6
  33.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  33.3%
White
6
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants
26.3  (6.0)
1.Primary Outcome
Title Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve
Hide Description 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.
Time Frame Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title All Study Participants Consuming PJ All Study Participants Comsuming PJ With Soy Protein All Study Participants Comsuming PJ With Soybean Flour
Hide Arm/Group Description:
Participants consumed PJ (236.5 mL) only
Participants consumed PJ (236.5 mL) mixed with soy protein isolate (20 g)
Participants consumed PJ (236.5 mL) with soybean flour protein (20 g)
Overall Number of Participants Analyzed 18 18 0
Mean (Standard Deviation)
Unit of Measure: micromol*h/L
0.074  (0.029) 0.075  (0.028)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Consuming PJ, All Study Participants Comsuming PJ With Soy Protein
Comments

Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.

Due to the quality issue of soybean flour, data from this intervention group was not analyzed.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.001
Estimation Comments [Not Specified]
Time Frame Adverse data was collected over a 3 week period
Adverse Event Reporting Description Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.
 
Arm/Group Title Study Participants Consuming PJ Alone Study Participants Consuming PJ With Soy Protein Study Participants Consuming PJ With Soybean Flour
Hide Arm/Group Description All participants consumed PJ (236.5 mL or 8 fl.oz) alone All participants consumed PJ (236.5 mL) mixed with 20 g of soy protein All participants consumed PJ (236.5 mL) mixed with 20 g of soybean flour
All-Cause Mortality
Study Participants Consuming PJ Alone Study Participants Consuming PJ With Soy Protein Study Participants Consuming PJ With Soybean Flour
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Participants Consuming PJ Alone Study Participants Consuming PJ With Soy Protein Study Participants Consuming PJ With Soybean Flour
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Participants Consuming PJ Alone Study Participants Consuming PJ With Soy Protein Study Participants Consuming PJ With Soybean Flour
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zhaoping Li, Professor
Organization: Center for Human Nutrition, Department of Medicine, UCLA David Geffen School of Medicine
Phone: 310-206-1987 ext 61987
EMail: zli@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Zhaoping Li, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02233478     History of Changes
Other Study ID Numbers: 14-000905
First Submitted: August 15, 2014
First Posted: September 8, 2014
Results First Submitted: September 25, 2018
Results First Posted: September 19, 2019
Last Update Posted: September 19, 2019