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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bragg ACV Liquid | Experimental | Apple Cider Vinegar (1 tablespoon) will be consumed |
|
| Placebo | Experimental | Water (4 ounces) will be consumed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bragg ACV Liquid | Other | Apple Cider Vinegar |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Up to 120 minutes |
| 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. |
Inclusion Criteria:
Males and females 20 - 50 years of age, inclusive 2. 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
Or,
Individuals of child-bearing potential must have a negative screening urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
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)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning on becoming sexually active during the study 3. Subjects with elevated fasting glucose > 5.6 mmol/L (> 100 mg/dL) and < 7.0 mmol/L (< 126 mg/dL) and/or elevated HbA1c (6.0-6.4%) and two or more of the other following markers associated with metabolic syndrome at screening:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B3L1 | Canada |
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| Other |
Water |
|
| 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 |
| 0 to Tmax, assessed up to 120 minutes |
| 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 | Up to 120 minutes |
| 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 | Up to 120 minutes |
| The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the Tmax for serum insulin | The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the Tmax for serum insulin | 0 to Tmax, assessed up to 120 minutes |
| Up to 120 minutes |
| 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. | Up to 120 minutes |