The goal of this clinical study is to investigate the efficacy of a Bragg Apple Cider Vinegar (ACV) liquid on postprandial glucose (PPG) excursion compared to a placebo following a standardized acute carbohydrate load. The main question it aims to answer is:
Is there a difference in the incremental area under the curve (iAUC) (from 0 - 120 mins following administration) for venous blood glucose between Bragg ACV liquid and placebo following an acute carbohydrate load.
Participants will \[describe the main tasks participants will be asked to consume 750 mg of Bragg Apple Cider Vinegar (ACV) liquid or water and undergo a blood draw to measure glucose, insulin, and future analysis markers.
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity or intolerance, preventing consumption of investigational product, placebo, or standardized meal
Poor venous access as assessed by the QI
Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the glucose metabolism or efficacy of the investigational product (Sections 7.3.1 and 7.3.2)
Crossover
Bragg ACV Liquid
Other interventionApple Cider Vinegar
Placebo
Other interventionWater
The difference in the iAUC(0 - 120 min) for venous blood glucose concentration between Bragg ACV liquid and placebo following an acute carbohydrate load
The difference in the iAUC(0 - 120 min) for venous blood glucose concentration between Bragg ACV liquid and placebo following an acute carbohydrate load
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the maximum concentration (Cmax) for venous blood glucose concentration
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the maximum concentration (Cmax) for venous blood glucose
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the time of maximum concentration (Tmax) for venous blood glucose concentration
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the time of maximum concentration (Tmax) for venous blood glucose concentration
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the AUC(0 - 120 min) for serum insulin
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the AUC(0 - 120 min) for serum insulin
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the Cmax for serum insulin
The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the Cmax for serum insulin
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Clinically relevant changes in blood pressure (BP) after supplementation
Clinically relevant changes in blood pressure (BP) after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event.
Clinically relevant changes in heart rate after supplementation
Clinically relevant changes in heart rate after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event.
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Bragg Live Food Products
Lead sponsor
KGK Science Inc.
Collaborator
