- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07254624
Pilot Assessment of Continuous Glucose Monitor for Post-meal Glucose Responses to Herbs and Spices.
Glucosidase Inhibitors and Glucose Metabolism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a pilot study which will enroll a maximum of 10 participants. There will be 3 different food entree preparations that participants will consume (1 entree per day within the 10 day period). The order in which participants eat the different entrees will be randomized. The 3 different food entree preparations are as follows: 1) prepared potato entree with no herbs and spices, 2) prepared potato entree paired with herbs and spices, 3) prepared potato entree with herbs and spices consumed at a subsequent meal.
Following enrollment, participants will be randomized to the order of entree preparation types and provided all of the entrees with the instructions for food preparation and order of consumption noted when they arrive at the scheduled study visit. The entrees will be standardized for caloric content, composition, and preparation method. Post-consumption glucose responses will be recorded by continuous glucose monitors, which will be provided to participants at the first study visit.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel L Smith Jr, PhD
- Phone Number: 205-934-4086
- Email: dsmithjr@uab.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- body mass index (BMI): 20-35
- no dietary restriction or food allergies to study items
- weight stable
- access to a smart phone
- willingness to wear a continuous glucose monitor for the duration of the study (at minimum 10 days)
Exclusion Criteria:
- pregnancy or anticipating pregnancy or lactation
- food allergy to study items
- diagnosed diabetes (type 1 or 2) or taking diabetes medications
- history of bariatric surgery
- consumed >1 serving of potatoes daily before enrollment
- 5% weight loss or gain within the past 6 months
- medical conditions or medication that would prevent the ability to comply with the treatment assignment and/or affect blood glucose or energy balance
- condition which would prevent the ability to wear a continuous glucose monitor on the upper arm for the study duration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Potato entree with no herbs or spices
consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms
|
A potato entree with a fixed macronutrient and calorie content, and standardized preparation method to evoke a post-prandial glucose response
|
|
Experimental: Potato entree with herbs or spices
consumption of a standardized potato entree including a mix of five herbs and spices at a fixed amount, matched for macronutrient, calorie and preparation method across arms
|
A potato entree with a fixed macronutrient and calorie content, and standardized preparation method to evoke a post-prandial glucose response
Herb and spice blend of dried oregano, basil, rosemary, garlic powder and onion powder
|
|
Sham Comparator: Potato entree with no herbs or spices, with herbs and spices mix at a subsequent meal
consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms - with a provision including a mix of five herbs and spices at a fixed amount to be consumed at a subsequent meal within the same day (>2 hours following the potato entree consumption)
|
A potato entree with a fixed macronutrient and calorie content, and standardized preparation method to evoke a post-prandial glucose response
Herb and spice blend of dried oregano, basil, rosemary, garlic powder and onion powder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-prandial glucose response
Time Frame: 0, 1, and 2 hours post-meal, as well as 24 hour continuous
|
Glucose response will be measured using continuous glucose monitors.
These devices will capture changes in glucose response from the start of the meal to about 2 hours postprandial.
|
0, 1, and 2 hours post-meal, as well as 24 hour continuous
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance assessment
Time Frame: 0-10 days
|
Feedback surveys to assess meal items likeability/acceptability, adherence and feasibility ('1-5' point scale, with '3' being 'neutral' and '5' indicating the participants 'strongly agree' with regarding the likeability and acceptability of the food item) in preparation for a full trial.
|
0-10 days
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300015105
- McCormick Science Institute (Other Grant/Funding Number: McCormick Science Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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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