Monitoring Postprandial Blood Glucose and Insulin in Fruit Snacks

NCT06458946 | Completed

• 1 other identifier: BIO-2405
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the postprandial glucose and insulin responses after different fruit snacks compared to confection control in a healthy population

Conditions

Blood Glucose; Blood Insulin

Keywords

blood glucose; metabolic health; cranberry fruit snacks

Outcome Measures

Primary Outcomes (1)

• Blood glucose iAUC - 2 hours

  The primary outcome variable will be glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min (iAUC0-120 min)

  2 hours

Secondary Outcomes (3)

• Blood glucose change

  2 hours

• blood glucose time to max concentration

  2 hours

• Blood insulin

  2 hours

Study Arms (6)

First product order: order not stated to protect study blinding

EXPERIMENTAL

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

Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit snack 2; Dietary Supplement: Fruit snack 3; Dietary Supplement: Fruit snack 4; Dietary Supplement: Fruit snack 5; Dietary Supplement: Confection control

Second product order: order not stated to protect study blinding

EXPERIMENTAL

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

Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit snack 2; Dietary Supplement: Fruit snack 3; Dietary Supplement: Fruit snack 4; Dietary Supplement: Fruit snack 5; Dietary Supplement: Confection control

Third product order: order not stated to protect study blinding

EXPERIMENTAL

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

Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit snack 2; Dietary Supplement: Fruit snack 3; Dietary Supplement: Fruit snack 4; Dietary Supplement: Fruit snack 5; Dietary Supplement: Confection control

Fourth product order: order not stated to protect study blinding

EXPERIMENTAL

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

Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit snack 2; Dietary Supplement: Fruit snack 3; Dietary Supplement: Fruit snack 4; Dietary Supplement: Fruit snack 5; Dietary Supplement: Confection control

Fifth product order: order not stated to protect study blinding

EXPERIMENTAL

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

Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit snack 2; Dietary Supplement: Fruit snack 3; Dietary Supplement: Fruit snack 4; Dietary Supplement: Fruit snack 5; Dietary Supplement: Confection control

Sixth product order: order not stated to protect study blinding

EXPERIMENTAL

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

Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit snack 2; Dietary Supplement: Fruit snack 3; Dietary Supplement: Fruit snack 4; Dietary Supplement: Fruit snack 5; Dietary Supplement: Confection control

Interventions

Fruit snack 1 DIETARY_SUPPLEMENT

Fruit snack with original level of sugar

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

Fruit snack 2 DIETARY_SUPPLEMENT

Fruit snack with reduced level of sugar

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

Fruit snack 3 DIETARY_SUPPLEMENT

Fruit snack with 0 added sugar - formulation 1

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

Fruit snack 4 DIETARY_SUPPLEMENT

Fruit snack with 0 added sugar - formulation 2

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

Fruit snack 5 DIETARY_SUPPLEMENT

Fruit snack from raisins

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

Confection control DIETARY_SUPPLEMENT

confection

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 h 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.
• 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, 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 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
• 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 2 months prior to visit 1.
• Currently, or planning to be, on a weight loss regimen during the study.
• Use of weight loss medication within 90 d 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 product.
• 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 2 months of visit 1.
• Blood donation \>450 mL within 8 weeks of visit 2 or plans to donate blood or plasma during the study period.

Sponsors & Collaborators

• Ocean Spray Cranberries, Inc.: lead

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Study Officials

• Aditi Shan, MD

  Biofortis Innovation Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Tested fruit bites are masked. Confection control is hard to mask (open label).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: May 22, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 31, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)