Diabete Type 2PSWNCT04591782
Investigation of PJ vs. Sugar on Glucose Levels in Healthy and Prediabetic Subjects
A study testing PomJuice, Water and Sugar Water in people with Diabete Type 2 and Pre Diabetes, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Pre Diabetes
- What is being tested?
- PomJuice, Water and Sugar Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition, 1000 Veteran Ave.
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabete Type 2, Pre Diabetes
- Being tested
- PomJuice, Water, Sugar Water
- Keywords
- pomegranate, antioxidants, prediabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomJuiceOther
Drink 8 oz pomegranate juice
WaterOther
Drink 8 oz water
Sugar WaterOther
Drink 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved in
| Study group | Role | What they receive |
|---|---|---|
| PomJuice (PJ) | Experimental | 8 oz of PJ Receives: Other: PomJuice |
| Sugar Water | Active comparator | 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved into it Receives: Other: Sugar Water |
| Water | Other | 8 oz of water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Feb 2019
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, UCLA Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591782
- Sponsor's protocol ID
- 18-001720
- Acronym
- PSW
- Status last verified
- May 2023
- First submitted
- 2 Oct 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zelicha H, Yang J, Diacova T, Wang J, Pan Y, Wang S, Heber D, Li Z. Pomegranate Juice Induces Similar Glycemic but Distinct Incretin Responses Compared with Sugar-Water: A Randomized Crossover Trial. J Nutr. 2026 Sep 5:101821. doi: 10.1016/j.tjnut.2026.101821. Online ahead of print.
PubMed 42700818
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Determine the Bioavailability of Sugar From Pomegranate Juice (PJ) vs. Sucrose
- ClinicalTrials.gov ID
- NCT04591782
- Acronym / sponsor ID
- PSW / 18-001720
- Conditions
- Diabete Type 2, Pre Diabetes
- Keywords
- pomegranate, antioxidants, prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PomJuice (PJ) | Experimental | Other: PomJuice8 oz of PJ |
| Sugar Water | Active comparator | Other: Sugar Water8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved into it |
| Water | Other | Other: Water8 oz of water |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomJuiceDrink 8 oz pomegranate juice | Other | PomJuice (PJ) |
| WaterDrink 8 oz water | Other | Water |
| Sugar WaterDrink 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved in | Other | Sugar Water |
Primary outcome
Number of participants with acute response to sugar water vs. pom juice vs. water
Time frame: 2 hours
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
Time frame: 15 days
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
Time frame: 2 hours
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
Time frame: 15 days
Compare the glycemic response and the ability to form microbiote urolithin from pomegranate ellagatanins in participants who consume pom juice vs. water.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 42700818Zelicha H, Yang J, Diacova T, Wang J, Pan Y, Wang S, Heber D, Li Z. Pomegranate Juice Induces Similar Glycemic but Distinct Incretin Responses Compared with Sugar-Water: A Randomized Crossover Trial. J Nutr. 2026 Sep 5:101821. doi: 10.1016/j.tjnut.2026.101821. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
UCLA Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PomJuice, Water and Sugar Water in people with Diabete Type 2 and Pre Diabetes, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute response to sugar water vs. pom juice vs. water (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.