RECRUITING

Postprandial Response to Fruit Juice

Conditions

Blood Glucose Blood Insulin fruit juice metabolic health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to determine postprandial responses to fruit juices.

Official Title

A Randomized, Crossover, Controlled Trial Investigating the Effects of Different Cranberry-Based Beverages on Postprandial Glucose, Insulin, and GLP-1

Quick Facts

Study Start:2025-07-21

Study Completion:2025-10-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07103083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥18 to ≤45 years of age at Visit 1. 2. BMI ≥18.5 and \<30.0 kg/m2 at Visit 1. 3. Fasting capillary glucose ≤110 mg/dL at Visit 1. 4. Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit. 5. Willing to abstain from alcohol consumption for 24 hours prior to each study visit. 6. 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. 7. 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). 8. Willing to maintain habitual physical activity level throughout the duration of the study. 9. 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. 10. Score of 7 to 10 on the Vein Access Scale at Visit 1. 11. 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. 12. 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.	1. 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. 2. 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). 3. Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications. 4. Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications. 5. Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1. 6. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator. 7. Weight loss or gain \>4.5 kg in the 60 days prior to Visit 1. 8. Currently, or planning to be, on a weight loss regimen during the study. 9. Use of weight loss medication within 90 days of Visit 1. 10. History of gastrointestinal surgery for weight reducing purposes. 11. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. 12. Known allergy or sensitivity to any ingredients or potential allergens contained in the study beverages. 13. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer. 14. History of any major trauma or major surgical event within 60 days of Visit 1. 15. Blood donation \>450 mL within 60 days of Visit 2 or plans to donate blood or plasma during the study period. 16. 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. 17. 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). 18. Exposed to any non-registered drug product within 30 days prior to Visit 1. 19. 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.

Inclusion Criteria

Exclusion Criteria

1. ≥18 to ≤45 years of age at Visit 1.
2. BMI ≥18.5 and \<30.0 kg/m2 at Visit 1.
3. Fasting capillary glucose ≤110 mg/dL at Visit 1.
4. Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit.
5. Willing to abstain from alcohol consumption for 24 hours prior to each study visit.
6. 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.
7. 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).
8. Willing to maintain habitual physical activity level throughout the duration of the study.
9. 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.
10. Score of 7 to 10 on the Vein Access Scale at Visit 1.
11. 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.
12. 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.

1. 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.
2. 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).
3. Unstable use (initiation or change in dose) within 30 days of Visit 1 of antihypertensive medications.
4. Unstable use (initiation or change in dose) within 30 days of Visit 1 of thyroid hormone replacement medications.
5. Use of medications or supplements that may influence carbohydrate metabolism within 30 days of Visit 1.
6. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan, vegetarian) at the discretion of the Clinical Investigator.
7. Weight loss or gain \>4.5 kg in the 60 days prior to Visit 1.
8. Currently, or planning to be, on a weight loss regimen during the study.
9. Use of weight loss medication within 90 days of Visit 1.
10. History of gastrointestinal surgery for weight reducing purposes.
11. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
12. Known allergy or sensitivity to any ingredients or potential allergens contained in the study beverages.
13. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
14. History of any major trauma or major surgical event within 60 days of Visit 1.
15. Blood donation \>450 mL within 60 days of Visit 2 or plans to donate blood or plasma during the study period.
16. 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.
17. 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).
18. Exposed to any non-registered drug product within 30 days prior to Visit 1.
19. 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.

Contacts and Locations

Study Contact

Kristen S Smith, PhD, RD

CONTACT

508-946-7204

ksmith@oceanspray.com

Christina Khoo, PhD

CONTACT

508-946-7925

ckhoo@oceanspray.com

Principal Investigator

Elizabeth Antoo, MD

PRINCIPAL_INVESTIGATOR

Biofortis Innovation Services

Study Locations (Sites)

Biofortis Innovation Services

Addison, Illinois, 60101

United States

Collaborators and Investigators

Sponsor: Ocean Spray Cranberries, Inc.

Elizabeth Antoo, MD, PRINCIPAL_INVESTIGATOR, Biofortis Innovation Services

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-21

Study Completion Date2025-10-29

Study Record Updates

Study Start Date2025-07-21

Study Completion Date2025-10-29

Terms related to this study

Keywords Provided by Researchers

fruit juice
blood glucose
metabolic health

Additional Relevant MeSH Terms

Blood Glucose
Blood Insulin