The goal of this clinical trial is to evaluate the efficacy of a Bragg ACV supplement on postprandial glucose excursion compared to a placebo following a standardized acute carbohydrate load.
Participants will be asked to consume an apple cider vinegar supplement 10 minutes prior to a standardized meal.
Males and females 20 - 65 years of age, inclusive
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
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
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 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 Supplement
Dietary supplementParticipants will be instructed to consume 1 capsule of either Bragg ACV Supplement or placebo 10 minutes prior to consumption of a standardized meal.
Placebo
Other interventionParticipants will be instructed to consume 1 capsule of either Bragg ACV Supplement or placebo 10 minutes prior to consumption of a standardized meal.
The difference in the incremental area under the curve (iAUC)(0 - 120 min) for venous blood glucose between Bragg ACV supplement and placebo following an acute carbohydrate load.
The difference in the incremental area under the curve (iAUC)(0 - 120 min) for venous blood glucose between Bragg ACV supplement and placebo following an acute carbohydrate load.
The difference between Bragg ACV supplement and placebo following an acute carbohydrate load in the maximum venous blood glucose concentration (Cmax)
The difference between Bragg ACV supplement and placebo following an acute carbohydrate load in the maximum venous blood glucose concentration (Cmax)
The difference between Bragg ACV supplement and placebo following an acute carbohydrate load in the AUC(0 - 120 min) for serum insulin
The difference between Bragg ACV supplement and placebo following an acute carbohydrate load in the AUC(0 - 120 min) for serum insulin
The difference between Bragg ACV supplement and placebo following an acute carbohydrate load in time to maximum concentration for serum insulin (Tmax)
The difference between Bragg ACV supplement and placebo following an acute carbohydrate load in time to maximum concentration for serum insulin (Tmax)
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 indicating an adverse effect as assessed by the Qualified Investigator
Clinically relevant changes in heart rate (HR) after supplementation
Clinically relevant changes in heart rate (HR) after supplementation indicating an adverse effect as assessed by the Qualified Investigator
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Bragg Live Food Products
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
