Blood GlucoseNCT05961475
Monitoring Postprandial Glycemia in Fruit Snacks
A study testing Fruit snack 1, Fruit Snack 2 and Fruit Snack 3 in people with Blood Glucose, run by Ocean Spray Cranberries, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Fruit snack 1, Fruit Snack 2 and Fruit Snack 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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.
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- 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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Glucose
- Being tested
- Fruit snack 1, Fruit Snack 2, Fruit Snack 3, Fruit Snack 4, White Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit snack 1Dietary supplement
Fruit snacks with original level of sugar
Fruit Snack 2Dietary supplement
Fruit snacks with original level of sugar and mulberry leaf extract
Fruit Snack 3Dietary supplement
Fruit snacks with reduced level of sugar
Fruit Snack 4Dietary supplement
Fruit snacks with zero added sugar
White BreadDietary supplement
White bread with matched carbohydrate as control
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Fruit snack 1; Dietary Supplement: Fruit Snack 2; Dietary Supplement: Fruit Snack 3; Dietary Supplement: Fruit Snack 4; Dietary Supplement: White Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose maximal concentration (Cmax) 2 hours after consumption
Glucose Cmax
Measured: 2 hour after consumption
Secondary outcomes (5)
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min
Glucose iAUC
Measured: 2 hours
Glucose time to maximum concentration within 2 hours after consumption
Glucose Tmax
Measured: 2 hours
Insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min
Insulin iAUC
Measured: 2 hours
Insulin maximal concentration (Cmax) 2 hours after consumption
Insulin Cmax
Measured: 2 hours
Insulin time to maximum concentration within 2 hours after consumption
Insulin Tmax
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start22 Jun 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocean Spray Cranberries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn Beckman, MD, Principal investigator, Biofortis Innovation Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961475
- Sponsor's protocol ID
- BIO-2309
- Status last verified
- Jun 2024
- First submitted
- 18 Jul 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Postprandial Glucose Response After Fruit Snack Consumption
- ClinicalTrials.gov ID
- NCT05961475
- Acronym / sponsor ID
- BIO-2309
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ocean Spray Cranberries, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| First product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Fruit snack 1, Dietary Supplement: Fruit Snack 2, Dietary Supplement: Fruit Snack 3, Dietary Supplement: Fruit Snack 4, Dietary Supplement: White BreadParticipants 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 |
| Second product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Fruit snack 1, Dietary Supplement: Fruit Snack 2, Dietary Supplement: Fruit Snack 3, Dietary Supplement: Fruit Snack 4, Dietary Supplement: White BreadParticipants 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 |
| Third product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Fruit snack 1, Dietary Supplement: Fruit Snack 2, Dietary Supplement: Fruit Snack 3, Dietary Supplement: Fruit Snack 4, Dietary Supplement: White BreadParticipants 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 |
| Fourth product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Fruit snack 1, Dietary Supplement: Fruit Snack 2, Dietary Supplement: Fruit Snack 3, Dietary Supplement: Fruit Snack 4, Dietary Supplement: White BreadParticipants 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 |
| Fifth product order: order not stated to protect study blinding | Experimental | Dietary Supplement: Fruit snack 1, Dietary Supplement: Fruit Snack 2, Dietary Supplement: Fruit Snack 3, Dietary Supplement: Fruit Snack 4, Dietary Supplement: White BreadParticipants 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- ≥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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit snack 1Fruit snacks with original level of sugar | Dietary supplement | 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 2Fruit snacks with original level of sugar and mulberry leaf extract | Dietary supplement | 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 3Fruit snacks with reduced level of sugar | Dietary supplement | 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 4Fruit snacks with zero added sugar | Dietary supplement | 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 BreadWhite bread with matched carbohydrate as control | Dietary supplement | 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 |
Primary outcome
Glucose maximal concentration (Cmax) 2 hours after consumption
Time frame: 2 hour after consumption
Glucose Cmax
5 secondary outcomes
Glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min
Time frame: 2 hours
Glucose time to maximum concentration within 2 hours after consumption
Time frame: 2 hours
Insulin incremental area under the curve (iAUC) from pre-product consumption to 120 min
Time frame: 2 hours
Insulin maximal concentration (Cmax) 2 hours after consumption
Time frame: 2 hours
Insulin time to maximum concentration within 2 hours after consumption
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Beckman, MD principal investigator
Biofortis Innovation Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit snack 1, Fruit Snack 2 and Fruit Snack 3 in people with Blood Glucose, run by Ocean Spray Cranberries, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose maximal concentration (Cmax) 2 hours after consumption (time frame: 2 hour after consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.