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

NCT02233478 | Completed Results

• 1 other identifier: 14-000905
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Pomegranate polyphenols; Soy Protein; Ellagitannins

Outcome Measures

Primary Outcomes (1)

• Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve

  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.

  Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period

Study Arms (3)

Pomegranate Juice

ACTIVE COMPARATOR

Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.

Dietary Supplement: Pomegranate Juice

Soybean Flour Protein

ACTIVE COMPARATOR

Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.

Dietary Supplement: Pomegranate Juice; Dietary Supplement: Soybean Flour Protein

Soy Isolate Protein

ACTIVE COMPARATOR

Subjects will be asked to take a dietary supplement on the day of intervention. Prior to intervention, subjects will be asked to avoid high-polyphenol foods, certain vitamins, minerals, herbs and dietary supplements for 4 days, dietary instruction will be provided. Blood samples will be taken at screen for safety labs. On study days 5, 13 and 21 a spot urine will be collected and a 7 hr serial blood draw will be performed at 0 hr, 30 min, 1 hr, 2 hr, 3 hr, 4 hr and 6 hr. Subjects will be provided with a light lunch with foods low in polyphenols. Subjects will only be able to eat the foods provided on the intervention days. Subjects will be asked to drink 32oz of water during the 7-hr period. Subjects will also be asked to collect all of their urines for 24 hrs, 2 consecutive days.

Dietary Supplement: Pomegranate Juice; Dietary Supplement: Soy Isolate Protein

Interventions

Pomegranate Juice DIETARY_SUPPLEMENT

Pomegranate Juice alone

Pomegranate Juice; Soy Isolate Protein; Soybean Flour Protein

Soybean Flour Protein DIETARY_SUPPLEMENT

Soybean Flour Protein combined with Pomegranate Juice

Also known as: Nutrasorb

Soybean Flour Protein

Soy Isolate Protein DIETARY_SUPPLEMENT

Soy Isolate Protein combined with Pomegranate Juice

Also known as: Solae

Soy Isolate Protein

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female \>20 and \< 45 years of age at the time the consent form is signed.
• Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.

You may not qualify if:

• Any subject who is eating more than 4 servings per day of fruits and vegetables, taking vitamin supplements or taking any antibiotics or other medication or dietary supplement which interfere with the absorption of polyphenols.
• Any subjects with a history of gastrointestinal surgery (except for appendectomy), diabetes mellitus, or other serious medical condition, such as chronic hepatitis or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as BP \>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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

Location

Results Point of Contact

• Title: Zhaoping Li, Professor
• Organization: Center for Human Nutrition, Department of Medicine, UCLA David Geffen School of Medicine

zli@mednet.ucla.edu

310-206-1987

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Chief Division of Clinical Nutrition

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: September 8, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 19, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-08

Locations

US (1)