- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256652
How Does YES Bar Affect Blood Glucose Levels?
Study Overview
Detailed Description
This remotely administered decentralized trial is designed to rigorously evaluate the impact of Yes Bar on blood sugar levels in a real-world setting, utilizing the latest in continuous glucose monitoring technology provided by Abbott's Lingo CGM. The founder of Yes Bar initiated this study in response to numerous anecdotal reports suggesting that Yes Bar does not cause the blood sugar spikes typically associated with snack consumption. The objective is to move beyond these anecdotal experiences to gather solid, data-driven evidence regarding the metabolic effects of consuming Yes Bar.
Participants in this study will engage in a unique and personal exploration of their metabolic health by tracking their blood sugar levels in response to consuming Yes Bars. Utilizing the Abbott Lingo CGM, which currently is compatible only with the iPhone, participants will monitor their blood glucose response, enabling an individualized assessment of how Yes Bar integrates into their dietary habits and metabolic health.
This study is not solely for the purpose of marketing Yes Bars but aims to contribute valuable insights for participants themselves, providing them with concrete data on how their bodies respond to Yes Bars. By participating in at least four individual experiments with Yes Bar over a period of 7 days, participants will not only contribute to a broader understanding of the snack's metabolic impact but will also receive a $17 gift card as a token of appreciation for their contribution to this scientific inquiry.
The primary goal of this trial is to scientifically assess the blood sugar response following the consumption of Yes Bar, leveraging the capabilities of the Abbott Lingo CGM. This endeavor also seeks to evaluate the feasibility of using consumer-grade continuous blood glucose monitors in dietary impact studies, in collaboration with Efforia. Through this study, we aim to bridge the gap between anecdotal evidence and empirical data, potentially transforming the way Yes Bar is marketed and perceived in the context of a healthy diet.
This study is not only pivotal for marketing strategies but, more importantly, serves as an opportunity for participants to gain insights into their own metabolic health, offering a personalized perspective on how Yes Bar might help in avoiding the undesirable blood sugar fluctuations that lead to energy crashes and cravings. Participants will emerge from this study with personalized data that could inform their dietary choices and perhaps introduce them to a new, metabolically friendly snack option.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10003
- Efforia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm where participants act as their own control
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The YES Bar, a gluten-free, plant-based snack, has gained attention for not spiking blood glucose levels like a lot of quick packaged snack bars.
An individual in the study will be provided with a mix of 6 different flavors of Yes Bar (all with generally the same ingredients and nutritional macros) and asked to conduct four individual experiments (with optional up to 6) in which they will test their blood glucose initially after fasting for two hours.
Then at 15 to 30 minute intervals over the following two hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
After Food Glucose Follow Up
Time Frame: Change from baseline (Day 1-0) in blood glucose levels immediately after consuming a specific food (Day 1)
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Timed Blood Glucose Monitoring for a Specific Food is an invaluable tool for understanding individual metabolic responses to food intake.
This survey involves using a continuous glucose monitor (CGM) to record blood glucose levels after consuming a specific food, helping to pinpoint how different foods impact blood sugar levels over a certain period.
The data collected can significantly aid in optimizing dietary choices by demonstrating the foods that cause glucose spikes or maintain stability.
Ultimately, the insights gained can lead to improved metabolic health, better energy levels, and an enhanced overall well-being.
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Change from baseline (Day 1-0) in blood glucose levels immediately after consuming a specific food (Day 1)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 38611
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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