Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319443
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-13
Brief Title:
Daily Vinegar Ingestion and 24-Hour Blood Glucose Control
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Daily Vinegar Ingestion and 24-Hour Blood Glucose Control in Adults With Glucose Intolerance A Randomized Crossover Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
When linking dietary interventions and blood glucose management much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods blood samples or glucometers These methods lack the capacity to provide insights into blood glucose dynamics 247
Recognizing this gap the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant
Recognizing this gap the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant
Detailed Description:
Participants are randomly assigned to either Group A or Group B using the Microsoft Excel randomization function Group A will be instructed to consume 4 tablespoons of red wine vinegar 2 tablespoons diluted in water at the start of the lunch and the dinner meals for the first 4 days of the trial Conversely participants in Group B will ingest the placebo for the initial 4 days ingesting one pill daily upon waking in the morning On days 5-9 participants will switch to the opposite treatment The red wine vinegar dosage 4 tablespoons containing 35 g acetic acid - this is the amount of acetic acid in a large 4-inch dill pickle and the placebo vinegar pill dosage one pill containing 0022 g acetic acid will be taken daily during the trial On visit 1 anthropometric measurements including height weight and body composition lean fat mass and body fat mass will be measured and the continuous glucose monitor will be placed on the upper arm The participants will be instructed to fast 8 hours no food or beverages with the exception of water ahead of visit 1 To ensure accurate use and data collection researchers discussed the operation of CGM devices and that these waterproof devices are to be continuously worn during the entire 9-day trial and will be removed on day 9 visit 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None