Evaluating the Postprandial Glucose Response After Fruit Snack Consumption

Ocean Spray Cranberries, Inc.1 site in 1 country20 target enrollmentJune 22, 2023

ConditionsBlood Glucose

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Blood Glucose
Sponsor: Ocean Spray Cranberries, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Glucose maximal concentration (Cmax) 2 hours after consumption
Status: Completed
Last Updated: last year

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 snack consumption in a healthy population.

Detailed Description

Fruit snacks made from sweetened dried fruits is a source of polyphenols, fiber, and other nutrients. The addition of sugar could aid in the taste, texture, and shelf life of these types of products. Fruit snacks with different levels of sugar were developed to meet various consumer needs. The postprandial glucose response in a healthy population is of interest in this regard. Mulberry leaf extract has been shown the benefit of blood glucose regulation in multiple studies. This is mainly due to the function of the most predominant iminosugar, 1-deoxynojirimycin (DNJ), in the mulberry leaf extract which acts as α-glucosidase inhibitor. Fruit snacks containing mulberry leaf extract were developed and the postprandial metabolic response against a reference (white bread matched for carbohydrate) will be observed.

Registry

clinicaltrials.gov

Start Date

June 22, 2023

End Date

October 31, 2023

Last Updated

last year

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 \<100 mg/dL at visit
•Willing to avoid consuming high-polyphenol containing foods (Appendix 2) 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 (Appendix provided for further checking).
•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 subject'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 (3 repeated measurements will be taken after subjects sit quietly for at least 5 mins. Each measurement will be separated by at least 2 minutes. The average of the last two measurements will be used).
•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.

Outcomes

Primary Outcomes

Glucose maximal concentration (Cmax) 2 hours after consumption

Time Frame: 2 hour after consumption

Glucose Cmax

Secondary Outcomes

Insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min(2 hours)
Insulin time to maximum concentration within 2 hours after consumption(2 hours)
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min(2 hours)
Insulin maximal concentration (Cmax) 2 hours after consumption(2 hours)
Glucose time to maximum concentration within 2 hours after consumption(2 hours)