Monitoring Postprandial Blood Glucose and Insulin in Fruit Snacks
NCT ID: NCT06458946
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2024-05-22
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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First product order: order not stated to protect study blinding
Participant will receive each of the 5 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
Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Second product order: order not stated to protect study blinding
Participant will receive each of the 5 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
Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Third product order: order not stated to protect study blinding
Participant will receive each of the 5 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
Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Fourth product order: order not stated to protect study blinding
Participant will receive each of the 5 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
Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Fifth product order: order not stated to protect study blinding
Participant will receive each of the 5 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
Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Sixth product order: order not stated to protect study blinding
Participant will receive each of the 5 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
Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Interventions
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Fruit snack 1
Fruit snack with original level of sugar
Fruit snack 2
Fruit snack with reduced level of sugar
Fruit snack 3
Fruit snack with 0 added sugar - formulation 1
Fruit snack 4
Fruit snack with 0 added sugar - formulation 2
Fruit snack 5
Fruit snack from raisins
Confection control
confection
Eligibility Criteria
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Inclusion Criteria
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 h 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. Willing to maintain habitual physical activity level throughout the duration of the study.
8. 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.
9. Score of 7 to 10 on the Vein Access Scale at visit 1.
10. 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.
11. 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.
Exclusion Criteria
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
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 2 months 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 d 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 product.
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 2 months of visit 1.
15. Blood donation \>450 mL within 8 weeks 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 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Ocean Spray Cranberries, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aditi Shan, MD
Role: PRINCIPAL_INVESTIGATOR
Biofortis Innovation Services
Locations
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Biofortis Innovation Services
Addison, Illinois, United States
Countries
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Other Identifiers
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BIO-2405
Identifier Type: -
Identifier Source: org_study_id
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