Postprandial Response to Fruit Juice
A Randomized, Crossover, Controlled Trial Investigating the Effects of Different Cranberry-Based Beverages on Postprandial Glucose, Insulin, and GLP-1
1 other identifier
interventional
18
1 country
1
Brief Summary
The goal of this clinical trial is to determine postprandial responses to fruit juices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedStudy Start
First participant enrolled
July 21, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2025
CompletedAugust 5, 2025
July 1, 2025
2 months
July 9, 2025
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood glucose iAUC - 2 hours
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min
2 hours
Secondary Outcomes (11)
Blood glucose maximal concentration
2 hours
Blood glucose time to max concentration
2 hours
Blood glucose change
2 hours
Blood insulin iAUC
2 hours
Blood insulin maximal concentration
2 hours
- +6 more secondary outcomes
Study Arms (6)
First product order: order not stated to protect study blinding
EXPERIMENTALParticipant 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
EXPERIMENTALParticipant 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
EXPERIMENTALParticipant 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
EXPERIMENTALParticipant 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
EXPERIMENTALParticipant 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
EXPERIMENTALParticipant 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.
Interventions
Fruit juice with zero sugar
Fruit juice with low sugar - formulation 1
Fruit juice with low sugar - formulation 2
Fruit juice with full sugar
Fruit juice with full sugar
Glucose control beverage
Eligibility Criteria
You may qualify if:
- ≥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.
- 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.
You may not qualify if:
- 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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ocean Spray Cranberries, Inc.lead
- Biofortis Innovation Servicescollaborator
Study Sites (1)
Biofortis Innovation Services
Addison, Illinois, 60101, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Antoo, MD
Biofortis Innovation Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
August 5, 2025
Study Start
July 21, 2025
Primary Completion
September 26, 2025
Study Completion
October 29, 2025
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share