CompletedNot Applicable

Monitoring Postprandial Blood Glucose and Insulin in Fruit Snacks

United States24 participantsStarted 2024-05-22

Plain-language 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

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. ≥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.

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 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.

What they're measuring

Blood glucose iAUC - 2 hours

Timeframe: 2 hours

Trial details

NCT IDNCT06458946

SponsorOcean Spray Cranberries, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

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