A Clinical Trial to Investigate the Efficacy of Bragg Apple Cider Vinegar on Blood Glucose Control in a Healthy Adult Population

NCT07043478 | Recruiting

• 1 other identifier: 25BGCFC01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Blood Glucose

Keywords

Blood glucose control; Bragg Apple Cider Vinegar; Apple Cider Vinegar

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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 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

  Up to 120 minutes

• 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

  0 to Tmax, assessed up to 120 minutes

Other Outcomes (3)

• Incidence of post-emergent adverse events (AE)

  Up to 120 minutes

• Clinically relevant changes in blood pressure (BP) after supplementation

  Up to 120 minutes

• Clinically relevant changes in heart rate after supplementation

  Up to 120 minutes

Study Arms (2)

Bragg ACV Liquid

EXPERIMENTAL

Apple Cider Vinegar (1 tablespoon) will be consumed

Other: Bragg ACV Liquid

Placebo

EXPERIMENTAL

Water (4 ounces) will be consumed

Other: Placebo

Interventions

Bragg ACV Liquid OTHER

Apple Cider Vinegar

Bragg ACV Liquid

Placebo OTHER

Water

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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) 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)

You may not qualify if:

• 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 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)
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Type I or Type II diabetes
• 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
• 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
• 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
• 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
• 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
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI

Sponsors & Collaborators

• Bragg Live Food Products: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

+12267819094;ext=300; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 29, 2025
• Study Start: August 5, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)