Study the Postprandial Blood Glucose and Insulin in Different Fruit Snacks

Ocean Spray Cranberries, Inc.1 site in 1 country24 target enrollmentMay 22, 2024

ConditionsBlood Glucose Blood Insulin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Blood Glucose
Sponsor: Ocean Spray Cranberries, Inc.
Enrollment: 24
Locations: 1
Primary Endpoint: Blood glucose iAUC - 2 hours
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Detailed Description

Fruit snacks made form sweetened dried fruits are great sources of polyphenols, fiber, and other nutrients. The addition of sugar could help the taste, texture, and shelf life of this type of product. Fruit snacks with different levels of sugar were developed to meet various consumer needs and the postprandial glucose response in healthy population compared with confection control is of interest to study.

Registry

clinicaltrials.gov

Start Date

May 22, 2024

End Date

October 31, 2024

Last Updated

9 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Ocean Spray Cranberries, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥18 to ≤45 years of age at visit
•BMI ≥18.5 and \<30.0 kg/m2 at visit
•Fasting capillary glucose \<110 mg/dL at visit
•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
•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.

Exclusion Criteria

•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
•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
•Currently, or planning to be, on a weight loss regimen during the study.
•Use of weight loss medication within 90 d of visit
•History of gastrointestinal surgery for weight reducing purposes.