Monitoring Postprandial Blood Glucose and Insulin in Fruit Snacks
Study the Postprandial Blood Glucose and Insulin in Different Fruit Snacks
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Junnan Gu
- Phone Number: 5089467862
- Email: JGU@OCEANSPRAY.COM
Study Locations
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis Innovation Services
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
- Score of 7 to 10 on the Vein Access Scale at visit 1.
- 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.
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.
- 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.
- 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.
- 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).
- Exposed to any non-registered drug product within 30 days prior to visit 1.
- Any condition the Investigator believes would interfere with the participant'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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: First product order: order not stated to protect study blinding
Participant 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
|
Fruit snack with original level of sugar
Fruit snack with reduced level of sugar
Fruit snack with 0 added sugar - formulation 1
Fruit snack with 0 added sugar - formulation 2
Fruit snack from raisins
confection
|
|
Experimental: Second product order: order not stated to protect study blinding
Participant 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
|
Fruit snack with original level of sugar
Fruit snack with reduced level of sugar
Fruit snack with 0 added sugar - formulation 1
Fruit snack with 0 added sugar - formulation 2
Fruit snack from raisins
confection
|
|
Experimental: Third product order: order not stated to protect study blinding
Participant 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
|
Fruit snack with original level of sugar
Fruit snack with reduced level of sugar
Fruit snack with 0 added sugar - formulation 1
Fruit snack with 0 added sugar - formulation 2
Fruit snack from raisins
confection
|
|
Experimental: Fourth product order: order not stated to protect study blinding
Participant 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
|
Fruit snack with original level of sugar
Fruit snack with reduced level of sugar
Fruit snack with 0 added sugar - formulation 1
Fruit snack with 0 added sugar - formulation 2
Fruit snack from raisins
confection
|
|
Experimental: Fifth product order: order not stated to protect study blinding
Participant 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
|
Fruit snack with original level of sugar
Fruit snack with reduced level of sugar
Fruit snack with 0 added sugar - formulation 1
Fruit snack with 0 added sugar - formulation 2
Fruit snack from raisins
confection
|
|
Experimental: Sixth product order: order not stated to protect study blinding
Participant 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
|
Fruit snack with original level of sugar
Fruit snack with reduced level of sugar
Fruit snack with 0 added sugar - formulation 1
Fruit snack with 0 added sugar - formulation 2
Fruit snack from raisins
confection
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose iAUC - 2 hours
Time Frame: 2 hours
|
The primary outcome variable will be glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min (iAUC0-120 min)
|
2 hours
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose change
Time Frame: 2 hours
|
Plasma glucose concentration change (Cmax - Cbaseline)
|
2 hours
|
|
blood glucose time to max concentration
Time Frame: 2 hours
|
Plasma glucose time to Cmax (Tmax)
|
2 hours
|
|
Blood insulin
Time Frame: 2 hours
|
Serum insulin iAUC, concentration change, time to the max concentration in 2 hours after consumption
|
2 hours
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Aditi Shan, MD, Biofortis Innovation Services
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- BIO-2405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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