Monitoring Postprandial Glycemia in Fruit Snacks

NCT05961475 | Completed

• 1 other identifier: BIO-2309
• Study Type: interventional
• Target: 20
• 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 snack consumption in a healthy population.

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (1)

• Glucose maximal concentration (Cmax) 2 hours after consumption

  Glucose Cmax

  2 hour after consumption

Secondary Outcomes (5)

• Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min

  2 hours

• Glucose time to maximum concentration within 2 hours after consumption

  2 hours

• Insulin 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

• Insulin time to maximum concentration within 2 hours after consumption

  2 hours

Study Arms (5)

First product order: order not stated to protect study blinding

EXPERIMENTAL

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; Dietary Supplement: Fruit Snack 2; Dietary Supplement: Fruit Snack 3; Dietary Supplement: Fruit Snack 4; Dietary Supplement: White Bread

Second product order: order not stated to protect study blinding

EXPERIMENTAL

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; Dietary Supplement: Fruit Snack 2; Dietary Supplement: Fruit Snack 3; Dietary Supplement: Fruit Snack 4; Dietary Supplement: White Bread

Third product order: order not stated to protect study blinding

EXPERIMENTAL

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; Dietary Supplement: Fruit Snack 2; Dietary Supplement: Fruit Snack 3; Dietary Supplement: Fruit Snack 4; Dietary Supplement: White Bread

Fourth product order: order not stated to protect study blinding

EXPERIMENTAL

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; Dietary Supplement: Fruit Snack 2; Dietary Supplement: Fruit Snack 3; Dietary Supplement: Fruit Snack 4; Dietary Supplement: White Bread

Fifth product order: order not stated to protect study blinding

EXPERIMENTAL

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; Dietary Supplement: Fruit Snack 2; Dietary Supplement: Fruit Snack 3; Dietary Supplement: Fruit Snack 4; Dietary Supplement: White Bread

Interventions

Fruit snack 1 DIETARY_SUPPLEMENT

Fruit snacks 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; Third product order: order not stated to protect study blinding

Fruit Snack 2 DIETARY_SUPPLEMENT

Fruit snacks with original level of sugar and mulberry leaf extract

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; Third product order: order not stated to protect study blinding

Fruit Snack 3 DIETARY_SUPPLEMENT

Fruit snacks 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; Third product order: order not stated to protect study blinding

Fruit Snack 4 DIETARY_SUPPLEMENT

Fruit snacks with zero added 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; Third product order: order not stated to protect study blinding

White Bread DIETARY_SUPPLEMENT

White bread with matched carbohydrate as control

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; 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 \<100 mg/dL at visit 1.
• 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.
• 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 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 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

• Dawn Beckman, 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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: June 22, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)