Investigation of PJ vs. Sugar on Glucose Levels in Healthy and Prediabetic Subjects (PSW)

Exploratory Study to Determine the Bioavailability of Sugar From Pomegranate Juice (PJ) vs. Sucrose

Pomegranate fruits and products, including juice, tea, wine and extracts are widely consumed and recognized for their health benefits. Pomegranate fruit possesses strong antioxidant, anti-inflammatory and antiproliferative properties. The effects of pomegranate on type 2 diabetic (T2DM) conditions have previously been reported. Although 8 oz. of Pom juice (PJ) contains 36.9 g of sugar, 12-week PomJ supplementation did not change plasma advanced glycated end-products, fasting glucose and HbA1C, but reduced lipid peroxidation in T2D subjects. Additionally, acute PJ consumption has been shown to lower postprandial glycemic response of a meal with high glycemic index (GI) and lower fasting blood glucose, and long-term PomJ consumption did not worsen diabetic markers. However, a large knowledge gap still exists regarding the form of sugars in PJ and the hormonal responses to PJ consumption in different physiological conditions. Therefore currently the consumption of PJ is not recommended for individuals with T2DM. This clinical study will focus on the short-term effects of PJ consumption on different diabetic variables to further evaluate the health benefits of PJ for T2DM.

Study Overview

• Status: Completed
• Conditions: Pre Diabetes; Diabete Type 2
• Intervention / Treatment: Other: PomJuice; Other: Sugar Water; Other: Water

Detailed Description

This study aims to measure the effects of PJ vs. sugar on glucose and insulin levels in apparently healthy normal weight and prediabetic overweight and obese subjects. Participants will be asked to consume one serving of PJ, sugar mix and water separated by one week of beige diet without PJ consumption (crossover design). The PJ will be provided by POMWonderful. Timed blood collections over a three-hour period following the juice/sugar/water consumption will be used to measure how PJ vs. sugar mix vs. water affects glucose metabolism/insulin sensitivity in human subjects.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Center for Human Nutrition, 1000 Veteran Ave.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 20-50 years and any racial/ethnic group
2. Typically consume low fiber/polyphenol diet (beige diet)
3. Healthy, normal weight individuals with a BMI of >18 to 26.9 kg/ m2 with fasting serum glucose <100mg/dL or A1c <5.7
4. Prediabetic, obese individuals with a BMI of >27 kg/ m2 and fasting serum glucose >100, but <126 mg/dL or A1c >5.7% but < 6.4%]
5. Subjects must read and sign the informed consent prior to participation
6. Subjects must be in generally good health
7. Subjects must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

1. Eating a high fiber/polyphenol diet or taking any medication or dietary supplements that interfere with the absorption of polyphenols.
2. History of gastrointestinal surgery, diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic 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 systolic BP >160mmHg, diastolic BP > 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history
3. Any subject currently taking blood thinning medications such as Warfarin or Coumadin
4. Currently uses tobacco products.
5. Currently has an alcohol intake > 20 g ⁄ day;
6. Currently has a coffee intake > 3 cups ⁄ day;
7. Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
8. Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
9. Allergy or sensitivity to pomegranate. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded
10. Taking antibiotics or laxatives within the past 3 months
11. Is unable or unwilling to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PomJuice (PJ); 8 oz of PJ	Other: PomJuice; Drink 8 oz pomegranate juice
Active Comparator: Sugar Water; 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved into it	Other: Sugar Water; Drink 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved in
Other: Water; 8 oz of water	Other: Water; Drink 8 oz water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with acute response to sugar water vs. pom juice vs. water	Compare the difference in blood glucose response to consuming PomJ compared to the same amount of sugar (fructose and glucose) mixed in water in a cross over study design	2 hours
Number of participants with hormonal changes in response to sugar water vs. pom juice vs. water	Compare the plasma concentration of principle hormones involved in glucose regulation (insulin, C-peptide, glucagon) , gut hormones (GLP-1 and GIP) and triglycerides.	15 days
Number of participants with acute response of plasma nitric oxide (NO) from sugar water vs. pom juice vs. water	Compare the acute response of plasma nitric oxide (NO) in participants who consume sugar alone, water alone or pomegranate juice	2 hours
Impact of gut microbiome in glycemic response to pom juice vs. sugar water	Compare the glycemic response and the ability to form microbiote urolithin from pomegranate ellagatanins in participants who consume pom juice vs. water.	15 days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Zhaoping Li, MD, PhD, UCLA Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: antioxidants; prediabetes; pomegranate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: 18-001720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No