Pilot Assessment of Continuous Glucose Monitor for Post-meal Glucose Responses to Herbs and Spices.
Purpose
The purpose of this study is to determine whether continuous glucose monitoring is sensitive to quantifying the glucose response related to consumption of a starchy vegetable (potato) in combination with or separate from consumption of herbs and spices at the same meal.
Condition
- Post-prandial Glucose Response
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Participants will serve as their own controls in this study. They will be randomized to the order they receive the prepared entrees. Post-prandial glucose responses will be compared across the three entree types.
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Sham Comparator Potato entree with no herbs or spices |
consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms |
|
|
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 |
|
|
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) |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35294
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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.