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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bragg ACV Supplement | Experimental | Bragg Apple Cider Vinegar (ACV) Supplement contains apple cider vinegar (standardized to 750 mg of acetic acid), zinc, and vitamin D. |
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| Placebo | Placebo Comparator | Placebo supplement contains microcrystalline cellulose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bragg ACV Supplement | Dietary Supplement | Participants will be instructed to consume 1 capsule of either Bragg ACV Supplement or placebo 10 minutes prior to consumption of a standardized meal. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 120 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0 and 120 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Day 0 to 8 |
| 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 |
Inclusion Criteria:
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
Or,
Individuals of child-bearing potential must have a negative baseline 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:
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:
Stable body weight defined as a <5% change in body weight in the three months prior to baseline, as assessed by the Qualified Investigator (QI)
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Agrees to comply with dietary guidelines and study requirements prior to in-clinic visits
Provided voluntary, written, informed consent to participate in the study
Otherwise healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Moulin, PhD | Contact | 2267819094 | mmoulin@kgkscience.com |
| 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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| Placebo | Other | Participants 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 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 |
| 0 and 120 minutes post dose |
| 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) | 0 and 120 minutes post dose |
| Day 0 to 8 |
| 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 | Day 0 to 8 |