Blood GlucoseNCT07103083
Postprandial Response to Fruit Juice
A study testing Beverage 1, Beverage 2 and Beverage 3 in people with Blood Glucose and Blood Insulin, run by Ocean Spray Cranberries, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine postprandial responses to fruit juices. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Blood Insulin
- What is being tested?
- Beverage 1, Beverage 2 and Beverage 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥18 to ≤45 years of age at Visit 1.
- BMI ≥18.5 and <30.0 kg/m2 at Visit 1.
- Fasting capillary glucose ≤110 mg/dL at Visit 1.
- Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit.
- Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
- Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of Visit 1, with no plans to begin use during the study period.
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- Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including Cannabidiol (CBD)/Tetrahydrocannabinol (THC) products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).
- Willing to maintain habitual physical activity level throughout the duration of the study.
- Willing to maintain habitual dietary pattern throughout the duration of the study, including stable intake of current vitamins, minerals, supplements and medications not interfering with study outcomes.
- Score of 7 to 10 on the Vein Access Scale at Visit 1.
- No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Clinical Investigator.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Section 9.1.1).
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications.
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications.
- Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1.
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
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- Weight loss or gain >4.5 kg in the 60 days prior to Visit 1.
- Currently, or planning to be, on a weight loss regimen during the study.
- Use of weight loss medication within 90 days of Visit 1.
- History of gastrointestinal surgery for weight reducing purposes.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Known allergy or sensitivity to any ingredients or potential allergens contained in the study beverages.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- History of any major trauma or major surgical event within 60 days of Visit 1.
- Blood donation >450 mL within 60 days of Visit 2 or plans to donate blood or plasma during the study period.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use (initiation or change in dose) within 30 days of Visit 1) of sex hormones for contraception.
- Recent history of (within 12 months of screening; Visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Exposed to any non-registered drug product within 30 days prior to Visit 1.
- Any condition the Clinical Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biofortis Innovation Services
Addison, Illinois, 60101
Kristen Taggart, 630-330-0463, kristen.taggart@mxns.com
Elizabeth Antoo, MD
About this study
Official title: A Randomized, Crossover, Controlled Trial Investigating the Effects of Different Cranberry-Based Beverages on Postprandial Glucose, Insulin, and GLP-1
The goal of this clinical trial is to determine postprandial responses to fruit juices.
Read the detailed description
Fruit juice is commonly consumed as a part of a balanced diet because of hydration, flavor, and nutrient content . Dietary Guidelines for Americans 2020-2025 recognizes 100% fruit juice as a nutrient-dense beverage that can contribute to fruit and nutrient intake . Liquid form of juices may lead to faster absorption and hormonal responses . Measuring these acute metabolic responses can help clarify the role of fruit juice in dietary patterns and metabolic health .
- Conditions
- Blood Glucose, Blood Insulin
- Being tested
- Beverage 1, Beverage 2, Beverage 3, Beverage 4, Beverage 5
- Keywords
- fruit juice, blood glucose, metabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage 1Dietary supplement
Fruit juice with zero sugar
Beverage 2Dietary supplement
Fruit juice with low sugar - formulation 1
Beverage 3Dietary supplement
Fruit juice with low sugar - formulation 2
Beverage 4Dietary supplement
Fruit juice with full sugar
Beverage 5Dietary supplement
Fruit juice with full sugar
Beverage 6Dietary supplement
Glucose control beverage
| Study group | Role | What they receive |
|---|---|---|
| First product order: order not stated to protect study blinding | Experimental | Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Beverage 1; Dietary Supplement: Beverage 2; Dietary Supplement: Beverage 3; Dietary Supplement: Beverage 4; Dietary Supplement: Beverage 5; Dietary Supplement: Beverage 6 |
| Second product order: order not stated to protect study blinding | Experimental | Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Beverage 1; Dietary Supplement: Beverage 2; Dietary Supplement: Beverage 3; Dietary Supplement: Beverage 4; Dietary Supplement: Beverage 5; Dietary Supplement: Beverage 6 |
| Third product order: order not stated to protect study blinding | Experimental | Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Beverage 1; Dietary Supplement: Beverage 2; Dietary Supplement: Beverage 3; Dietary Supplement: Beverage 4; Dietary Supplement: Beverage 5; Dietary Supplement: Beverage 6 |
| Fourth product order: order not stated to protect study blinding | Experimental | Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Beverage 1; Dietary Supplement: Beverage 2; Dietary Supplement: Beverage 3; Dietary Supplement: Beverage 4; Dietary Supplement: Beverage 5; Dietary Supplement: Beverage 6 |
| Fifth product order: order not stated to protect study blinding | Experimental | Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Beverage 1; Dietary Supplement: Beverage 2; Dietary Supplement: Beverage 3; Dietary Supplement: Beverage 4; Dietary Supplement: Beverage 5; Dietary Supplement: Beverage 6 |
| Sixth product order: order not stated to protect study blinding | Experimental | Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. Receives: Dietary Supplement: Beverage 1; Dietary Supplement: Beverage 2; Dietary Supplement: Beverage 3; Dietary Supplement: Beverage 4; Dietary Supplement: Beverage 5; Dietary Supplement: Beverage 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose iAUC - 2 hours
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min
Measured: 2 hours
Secondary outcomes (11)
Blood glucose maximal concentration
Plasma glucose maximal concentration (Cmax)
Measured: 2 hours
Blood glucose time to max concentration
Plasma glucose time to Cmax
Measured: 2 hours
Blood glucose change
Plasma glucose concentration change from (C-max) - (C-baseline))
Measured: 2 hours
Blood insulin iAUC
Serum insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min
Measured: 2 hours
Blood insulin maximal concentration
Serum insulin maximal concentration (C-max)
Measured: 2 hours
Blood insulin time to max concentration
Serum insulin time to C-max
Measured: 2 hours
Blood insulin change
Serum insulin concentration change from (C-max - (C-baseline))
Measured: 2 hours
GLP-1 iAUC
GLP-1 incremental area under the curve (iAUC) from pre-product consumption to 120 min
Measured: 2 hours
GLP-1 Maximal Concentration
GLP-1 maximal concentration (C-max)
Measured: 2 hours
GLP-1 Time to Max Concentration
GLP-1 time to C-max
Measured: 2 hours
GLP-1 Change
GLP-1 concentration change from (C-max - (C-baseline))
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start21 Jul 2025
- Primary completion26 Sep 2025 (estimated)
- Study completion29 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocean Spray Cranberries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Responsible party
- Sponsor
- Investigators
- Elizabeth Antoo, MD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103083
- Sponsor's protocol ID
- BIO-2508
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Controlled Trial Investigating the Effects of Different Cranberry-Based Beverages on Postprandial Glucose, Insulin, and GLP-1
- ClinicalTrials.gov ID
- NCT07103083
- Acronym / sponsor ID
- BIO-2508
- Conditions
- Blood Glucose, Blood Insulin
- Keywords
- fruit juice, blood glucose, metabolic health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ocean Spray Cranberries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 29 Oct 2025 (estimated)
- First posted
- 5 Aug 2025 (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.
The goal of this clinical trial is to determine postprandial responses to fruit juices.
Detailed description
Fruit juice is commonly consumed as a part of a balanced diet because of hydration, flavor, and nutrient content . Dietary Guidelines for Americans 2020-2025 recognizes 100% fruit juice as a nutrient-dense beverage that can contribute to fruit and nutrient intake . Liquid form of juices may lead to faster absorption and hormonal responses . Measuring these acute metabolic responses can help clarify the role of fruit juice in dietary patterns and metabolic health .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| First product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Beverage 1, Dietary Supplement: Beverage 2, Dietary Supplement: Beverage 3, Dietary Supplement: Beverage 4, Dietary Supplement: Beverage 5, Dietary Supplement: Beverage 6Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. |
| Second product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Beverage 1, Dietary Supplement: Beverage 2, Dietary Supplement: Beverage 3, Dietary Supplement: Beverage 4, Dietary Supplement: Beverage 5, Dietary Supplement: Beverage 6Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. |
| Third product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Beverage 1, Dietary Supplement: Beverage 2, Dietary Supplement: Beverage 3, Dietary Supplement: Beverage 4, Dietary Supplement: Beverage 5, Dietary Supplement: Beverage 6Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. |
| Fourth product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Beverage 1, Dietary Supplement: Beverage 2, Dietary Supplement: Beverage 3, Dietary Supplement: Beverage 4, Dietary Supplement: Beverage 5, Dietary Supplement: Beverage 6Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. |
| Fifth product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Beverage 1, Dietary Supplement: Beverage 2, Dietary Supplement: Beverage 3, Dietary Supplement: Beverage 4, Dietary Supplement: Beverage 5, Dietary Supplement: Beverage 6Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. |
| Sixth product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Beverage 1, Dietary Supplement: Beverage 2, Dietary Supplement: Beverage 3, Dietary Supplement: Beverage 4, Dietary Supplement: Beverage 5, Dietary Supplement: Beverage 6Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- ≥18 to ≤45 years of age at Visit 1.
- BMI ≥18.5 and <30.0 kg/m2 at Visit 1.
- Fasting capillary glucose ≤110 mg/dL at Visit 1.
- Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit.
- Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
Key exclusion criteria (19 listed)
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Clinical Investigator.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Section 9.1.1).
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications.
- Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications.
- Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1.
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 |
|---|---|---|
| Beverage 1Fruit juice with zero sugar | Dietary supplement | Fifth product order: order not stated to protect study blinding, First product order: order not stated to protect study blinding, Fourth product order: order not stated to protect study blinding, Second product order: order not stated to protect study blinding, Sixth product order: order not stated to protect study blinding, Third product order: order not stated to protect study blinding |
| Beverage 2Fruit juice with low sugar - formulation 1 | Dietary supplement | Fifth product order: order not stated to protect study blinding, First product order: order not stated to protect study blinding, Fourth product order: order not stated to protect study blinding, Second product order: order not stated to protect study blinding, Sixth product order: order not stated to protect study blinding, Third product order: order not stated to protect study blinding |
| Beverage 3Fruit juice with low sugar - formulation 2 | Dietary supplement | Fifth product order: order not stated to protect study blinding, First product order: order not stated to protect study blinding, Fourth product order: order not stated to protect study blinding, Second product order: order not stated to protect study blinding, Sixth product order: order not stated to protect study blinding, Third product order: order not stated to protect study blinding |
| Beverage 4Fruit juice with full sugar | Dietary supplement | Fifth product order: order not stated to protect study blinding, First product order: order not stated to protect study blinding, Fourth product order: order not stated to protect study blinding, Second product order: order not stated to protect study blinding, Sixth product order: order not stated to protect study blinding, Third product order: order not stated to protect study blinding |
| Beverage 5Fruit juice with full sugar | Dietary supplement | Fifth product order: order not stated to protect study blinding, First product order: order not stated to protect study blinding, Fourth product order: order not stated to protect study blinding, Second product order: order not stated to protect study blinding, Sixth product order: order not stated to protect study blinding, Third product order: order not stated to protect study blinding |
| Beverage 6Glucose control beverage | Dietary supplement | Fifth product order: order not stated to protect study blinding, First product order: order not stated to protect study blinding, Fourth product order: order not stated to protect study blinding, Second product order: order not stated to protect study blinding, Sixth product order: order not stated to protect study blinding, Third product order: order not stated to protect study blinding |
Primary outcome
Blood glucose iAUC - 2 hours
Time frame: 2 hours
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min
11 secondary outcomes
Blood glucose maximal concentration
Time frame: 2 hours
Blood glucose time to max concentration
Time frame: 2 hours
Blood glucose change
Time frame: 2 hours
Blood insulin iAUC
Time frame: 2 hours
Blood insulin maximal concentration
Time frame: 2 hours
Blood insulin time to max concentration
Time frame: 2 hours
Blood insulin change
Time frame: 2 hours
GLP-1 iAUC
Time frame: 2 hours
GLP-1 Maximal Concentration
Time frame: 2 hours
GLP-1 Time to Max Concentration
Time frame: 2 hours
GLP-1 Change
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Elizabeth Antoo, MD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage 1, Beverage 2 and Beverage 3 in people with Blood Glucose and Blood Insulin, run by Ocean Spray Cranberries, Inc. 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 12 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen S Smith, PhD, RD (508-946-7204, ksmith@oceanspray.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose iAUC - 2 hours (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2025.