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

Primary Purpose

Diabete Type 2, Pre Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PomJuice

Water

Sugar Water

About this trial

This is an interventional other trial for Diabete Type 2 focused on measuring pomegranate, antioxidants, prediabetes

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Eating a high fiber/polyphenol diet or taking any medication or dietary supplements that interfere with the absorption of polyphenols.
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
Any subject currently taking blood thinning medications such as Warfarin or Coumadin
Currently uses tobacco products.
Currently has an alcohol intake > 20 g ⁄ day;
Currently has a coffee intake > 3 cups ⁄ day;
Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
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
Taking antibiotics or laxatives within the past 3 months
Is unable or unwilling to comply with the study protocol.

Sites / Locations

UCLA Center for Human Nutrition, 1000 Veteran Ave.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

PomJuice (PJ)

Sugar Water

Water

Arm Description

8 oz of PJ

8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved into it

8 oz of water

Outcomes

Primary Outcome Measures

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

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.

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04591782

First Posted

October 2, 2020

Last Updated

May 4, 2023

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04591782

Brief Title

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

Acronym

PSW

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

December 20, 2021 (Actual)

Study Completion Date

December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabete Type 2, Pre Diabetes

Keywords

pomegranate, antioxidants, prediabetes

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PomJuice (PJ)

Arm Type

Experimental

Arm Description

8 oz of PJ

Arm Title

Sugar Water

Arm Type

Active Comparator

Arm Description

8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved into it

Arm Title

Water

Arm Type

Other

Arm Description

8 oz of water

Intervention Type

Other

Intervention Name(s)

PomJuice

Intervention Description

Drink 8 oz pomegranate juice

Intervention Type

Other

Intervention Name(s)

Water

Intervention Description

Drink 8 oz water

Intervention Type

Other

Intervention Name(s)

Sugar Water

Intervention Description

Drink 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved in

Primary Outcome Measure Information:

Title

Number of participants with acute response to sugar water vs. pom juice vs. water

Description

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

Time Frame

2 hours

Title

Number of participants with hormonal changes in response to sugar water vs. pom juice vs. water

Description

Compare the plasma concentration of principle hormones involved in glucose regulation (insulin, C-peptide, glucagon) , gut hormones (GLP-1 and GIP) and triglycerides.

Time Frame

15 days

Title

Number of participants with acute response of plasma nitric oxide (NO) from sugar water vs. pom juice vs. water

Description

Compare the acute response of plasma nitric oxide (NO) in participants who consume sugar alone, water alone or pomegranate juice

Time Frame

2 hours

Title

Impact of gut microbiome in glycemic response to pom juice vs. sugar water

Description

Compare the glycemic response and the ability to form microbiote urolithin from pomegranate ellagatanins in participants who consume pom juice vs. water.

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 20-50 years and any racial/ethnic group Typically consume low fiber/polyphenol diet (beige diet) Healthy, normal weight individuals with a BMI of >18 to 26.9 kg/ m2 with fasting serum glucose <100mg/dL or A1c <5.7 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%] Subjects must read and sign the informed consent prior to participation Subjects must be in generally good health Subjects must be able and willing to comply with the requirements of the protocol. Exclusion Criteria: Eating a high fiber/polyphenol diet or taking any medication or dietary supplements that interfere with the absorption of polyphenols. 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 Any subject currently taking blood thinning medications such as Warfarin or Coumadin Currently uses tobacco products. Currently has an alcohol intake > 20 g ⁄ day; Currently has a coffee intake > 3 cups ⁄ day; Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator. Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly 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 Taking antibiotics or laxatives within the past 3 months Is unable or unwilling to comply with the study protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li, MD, PhD

Organizational Affiliation

UCLA Professor of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Center for Human Nutrition, 1000 Veteran Ave.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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