Pilot Assessment of Continuous Glucose Monitor for Post-meal Glucose Responses to Herbs and Spices.

The University of Alabama at Birmingham

Status: Not yet enrolling

Conditions: Post-prandial Glucose Response

Treatments: Other: Potato entree; Other: Mix of five herbs and spices

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07254624

IRB-300015105

McCormick Science Institute (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 3 patient groups

Potato entree with no herbs or spices

Sham Comparator group

Description:

consumption of a standardized potato entree, matched for macronutrient, calorie and preparation method across arms

Treatment:

Other: Potato entree

Potato entree with herbs or spices

Experimental group

Description:

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

Treatment:

Other: Mix of five herbs and spices

Other: Potato entree

Potato entree with no herbs or spices, with herbs and spices mix at a subsequent meal

Sham Comparator group

Description:

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)

Treatment:

Other: Mix of five herbs and spices

Other: Potato entree