Monitoring Postprandial Glycemia in Fruit Snacks

Evaluating the Postprandial Glucose Response After Fruit Snack Consumption

The goal of this clinical trial is to compare the postprandial glucose and insulin responses after different fruit snack consumption in a healthy population.

Study Overview

• Status: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Dietary supplement: Fruit snack 1; Dietary supplement: Fruit Snack 2; Dietary supplement: Fruit Snack 3; Dietary supplement: Fruit Snack 4; Dietary supplement: White Bread

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Innovation Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. ≥18 to ≤45 years of age at visit 1.
2. BMI ≥18.5 and <30.0 kg/m2 at visit 1.
3. Fasting capillary glucose <100 mg/dL at visit 1.
4. Willing to avoid consuming high-polyphenol containing foods (Appendix 2) 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 (Appendix provided for further checking).
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:

1. 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.
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 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).
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 subject'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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First product order: order not stated to protect study blinding; Participants 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; Fruit snacks with original level of sugar; Dietary supplement: Fruit Snack 2; Fruit snacks with original level of sugar and mulberry leaf extract; Dietary supplement: Fruit Snack 3; Fruit snacks with reduced level of sugar; Dietary supplement: Fruit Snack 4; Fruit snacks with zero added sugar; Dietary supplement: White Bread; White bread with matched carbohydrate as control
Experimental: Second product order: order not stated to protect study blinding; Participants 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; Fruit snacks with original level of sugar; Dietary supplement: Fruit Snack 2; Fruit snacks with original level of sugar and mulberry leaf extract; Dietary supplement: Fruit Snack 3; Fruit snacks with reduced level of sugar; Dietary supplement: Fruit Snack 4; Fruit snacks with zero added sugar; Dietary supplement: White Bread; White bread with matched carbohydrate as control
Experimental: Third product order: order not stated to protect study blinding; Participants 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; Fruit snacks with original level of sugar; Dietary supplement: Fruit Snack 2; Fruit snacks with original level of sugar and mulberry leaf extract; Dietary supplement: Fruit Snack 3; Fruit snacks with reduced level of sugar; Dietary supplement: Fruit Snack 4; Fruit snacks with zero added sugar; Dietary supplement: White Bread; White bread with matched carbohydrate as control
Experimental: Fourth product order: order not stated to protect study blinding; Participants 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; Fruit snacks with original level of sugar; Dietary supplement: Fruit Snack 2; Fruit snacks with original level of sugar and mulberry leaf extract; Dietary supplement: Fruit Snack 3; Fruit snacks with reduced level of sugar; Dietary supplement: Fruit Snack 4; Fruit snacks with zero added sugar; Dietary supplement: White Bread; White bread with matched carbohydrate as control
Experimental: Fifth product order: order not stated to protect study blinding; Participants 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; Fruit snacks with original level of sugar; Dietary supplement: Fruit Snack 2; Fruit snacks with original level of sugar and mulberry leaf extract; Dietary supplement: Fruit Snack 3; Fruit snacks with reduced level of sugar; Dietary supplement: Fruit Snack 4; Fruit snacks with zero added sugar; Dietary supplement: White Bread; White bread with matched carbohydrate as control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose maximal concentration (Cmax) 2 hours after consumption	Glucose Cmax	2 hour after consumption

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ocean Spray Cranberries, Inc.
• Investigators: Principal Investigator: Dawn Beckman, MD, Biofortis Innovation Services

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No