Phase
Condition
N/ATreatment
Placebo
Bragg ACV Liquid
Clinical Study ID
Ages 20-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 changingto heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning on becoming sexually activeduring the study 3. Subjects with elevated fasting glucose > 5.6 mmol/L (> 100mg/dL) and < 7.0 mmol/L (< 126 mg/dL) and/or elevated HbA1c (6.0-6.4%) and two ormore of the other following markers associated with metabolic syndrome at screening:
Abdominal obesity: waist circumference > 102 cm (40 inches) in men and > 88 cm (35 inches) in women
Hypertension: systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg
Elevated TG: > 150 mg/dL (1.7 mmol/L)
Low HDL-C: < 40 mg/dL (1.03 mmol/L) in men and < 50 mg/dL (1.29 mmol/L) inwomen 4. Stable body weight defined as a <5% change in body weight in the threemonths 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
Agrees to comply with dietary guidelines and study requirements prior toin-clinic visits (see Section 9.1) 7. Provided voluntary, written, informedconsent to participate in the study 8. Otherwise healthy as determined bymedical history and laboratory results as assessed by Qualified Investigator (QI)
Exclusion
Exclusion Criteria:
Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study
Allergy, sensitivity or intolerance, preventing consumption of investigationalproduct, 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 efficacyof the investigational product (Sections 7.3.1 and 7.3.2)
Unstable metabolic disease or chronic diseases as assessed by the QI
Current or history of any significant diseases of the gastrointestinal tract asassessed by the QI
Unstable hypertension. Treatment on a stable dose of medication for at least 3months will be considered by the QI
Type I or Type II diabetes
Significant cardiovascular event in the past 6 months. Participants with nosignificant cardiovascular event on stable medication may be included afterassessment by the QI on a case-by-case basis
History of or current diagnosis with kidney and/or liver diseases as assessed by theQI on a case-by-case basis, with the exception of history of kidney stones inparticipants who are symptom free for 6 months
Self-reported confirmation of current or pre-existing thyroid condition. Treatmenton a stable dose of medication for at least 3 months will be considered by the QI
Major surgery in the past 3 months or individuals who have planned surgery duringthe course of the study. Participants with minor surgery will be considered on acase-by-case basis by the QI
Cancer, except skin basal cell carcinoma completely excised with no chemotherapy orradiation with a follow up that is negative. Volunteers with cancer in fullremission for more than five years after diagnosis are acceptable
Individuals with an autoimmune disease or are immune compromised as assessed by theQI
Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis asassessed by the QI
Self-reported confirmation of blood/bleeding disorders as assessed by the QI
Chronic inhalation or edible use of cannabinoid products (>1 time/month). Occasionalusers must agree to abstain from use while participating in the study
Regular use of tobacco or nicotine products in the past six months, as assessed bythe QI. Occasional users will be required to washout and abstain for the duration ofthe study period
Alcohol intake average of >2 standard drinks per day as assessed by the QI
Alcohol or drug abuse within the last 12 months
Clinically significant abnormal laboratory results at screening as assessed by theQI
Blood donation 30 days prior to baseline, during the study, or a planned donationwithin 30 days of the last study visit
Participation in other clinical research studies 30 days prior to baseline asassessed by the QI
Individuals who are unable to give informed consent
Any other condition or lifestyle factor, that, in the opinion of the QI, mayadversely affect the participant's ability to complete the study or its measures orpose significant risk to the participant
Study Design
Connect with a study center
KGK Science Inc.
London, Ontario N6B3L1
CanadaActive - Recruiting
KGK Science Inc.
London 6058560, Ontario 6093943 N6B3L1
CanadaSite Not Available

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