Blood Glucose, Healthy
Conditions
Keywords
Blood glucose control, Bragg Apple Cider Vinegar, Apple Cider Vinegar
Brief summary
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.
Interventions
OTHERBragg ACV Liquid
Apple Cider Vinegar
OTHERPlacebo
Water
Sponsors
Bragg Live Food Products
KGK Science Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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: 1. Abdominal obesity: waist circumference \> 102 cm (40 inches) in men and \> 88 cm (35 inches) in women 2. Hypertension: systolic blood pressure \> 130 mmHg or diastolic blood pressure \> 85 mmHg 3. Elevated TG: \> 150 mg/dL (1.7 mmol/L) 4. Low HDL-C: \< 40 mg/dL (1.03 mmol/L) in men and \< 50 mg/dL (1.29 mmol/L) in women 4. 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) 5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 6. Agrees to comply with dietary guidelines and study requirements prior to in-clinic visits (see Section 9.1) 7. Provided voluntary, written, informed consent to participate in the study 8. Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)
Exclusion criteria
1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity or intolerance, preventing consumption of investigational product, placebo, or standardized meal 3. Poor venous access as assessed by the QI 4. 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) 5. Unstable metabolic disease or chronic diseases as assessed by the QI 6. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI 7. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 8. Type I or Type II diabetes 9. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis 10. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months 11. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI 12. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI 13. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable 14. Individuals with an autoimmune disease or are immune compromised as assessed by the QI 15. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI 16. Self-reported confirmation of blood/bleeding disorders as assessed by the QI 17. Chronic inhalation or edible use of cannabinoid products (\>1 time/month). Occasional users must agree to abstain from use while participating in the study 18. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period 19. Alcohol intake average of \>2 standard drinks per day as assessed by the QI 20. Alcohol or drug abuse within the last 12 months 21. Clinically significant abnormal laboratory results at screening as assessed by the QI 22. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 23. Participation in other clinical research studies 30 days prior to baseline as assessed by the QI 24. Individuals who are unable to give informed consent 25. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The difference in the iAUC(0 - 120 min) for venous blood glucose concentration between Bragg ACV liquid and placebo following an acute carbohydrate load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the maximum concentration (Cmax) for venous blood glucose concentration | Up to 120 minutes | 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 | 0 to Tmax, assessed up to 120 minutes | 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 | 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 Cmax 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 Tmax for serum insulin | 0 to Tmax, assessed up to 120 minutes | The difference between Bragg ACV liquid and placebo following an acute carbohydrate load in the Tmax for serum insulin |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORDavid Crowley, MD
KGK Science Inc.
Outcome results
None listed