N/A
N=18
Comparing the Effect of Whey and Soy Protein on the Absorption of Pomegranate Polyphenols in the Human Body
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02233478 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve — 0.074; 0.075 micromol*h/L — p=0.82
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pomegranate Juice (Dietary_supplement); Soybean Flour Protein (Dietary_supplement); Soy Isolate Protein (Dietary_supplement)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve |
0.074; 0.075 | 0.82 |
Summary
This study is comparing the quantity of active metabolites from consuming pomegranate juice in three different preparations. People who participate in this study will come in to the Center for a screening visit, which includes a blood test and medical history. If you qualify based on the screening visit, you will then come in to the Center while fasting in the morning on three different days. You will eat a standardized breakfast and drink one of three juices, and then remain for metabolic testing at the Center for a period of time after eating. You will also be provided a standardized lunch and water during this period. Each of those visits will last about 7 hours. During this time, and for the rest of the 24 hours following drinking the juice, you will collect all of your urine. Following all three of these 7-hour visits, you will return to the Center again the next day for a fasting blood draw, drop off your urine sample, and pick up a new container to collect another 24 hour urine sample. The following day, you will return to the Center to drop off your second urine sample collection.
Eligibility Criteria
Inclusion Criteria
- Male or female >20 and 160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease corrected with medication to normal laboratory values) as indicated by medical history or routine physical examination.
- Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery
- Is currently a smoker who has a therapeutic plan to quit smoking anytime during the study period; or if not a current smoker, has quit smoking within the past 3 months.
- Known HIV positive.
- Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
- Currently receiving systemic chemotherapy and/or radiotherapy.
- Active bleeding.
- Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject who is allergic to soy protein.
- In the opinion of the study investigator has a risk of non-compliance with study procedures, or can not read, understand or complete study related materials.
Data sourced from ClinicalTrials.gov (NCT02233478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.