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

N/ANot Yet RecruitingNCT07254624

University of Alabama at Birmingham10 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Post-prandial Glucose Response

Interventions

Mix of five herbs and spicesOTHER

Herb and spice blend of dried oregano, basil, rosemary, garlic powder and onion powder

Potato entreeOTHER

A potato entree with a fixed macronutrient and calorie content, and standardized preparation method to evoke a post-prandial glucose response

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Post-prandial glucose response

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.

Time frame: 0, 1, and 2 hours post-meal, as well as 24 hour continuous

Secondary Outcomes

Acceptance assessment

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.

Time frame: 0-10 days

Central Contacts

Daniel L Smith Jr, PhD

CONTACT

205-934-4086 dsmithjr@uab.edu

Data from ClinicalTrials.gov

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