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

NCT07100977 | Not Yet Recruiting

• 1 other identifier: 25BGCFA02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postprandial Glucose; Blood Glucose Concentration

Keywords

Apple Cider Vinegar; Apple Cider Vinegar Supplement; Bragg Live Food Products

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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)

  0 and 120 minutes post dose

Other Outcomes (3)

• Incidence of post-emergent adverse events (AE)

  Day 0 to 8

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

  Day 0 to 8

• Clinically relevant changes in heart rate (HR) after supplementation

  Day 0 to 8

Study Arms (2)

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.

Dietary Supplement: Bragg ACV Supplement

Placebo

PLACEBO COMPARATOR

Placebo supplement contains microcrystalline cellulose.

Other: Placebo

Interventions

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.

Bragg ACV Supplement

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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

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 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

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

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

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-07

Locations

CA (1)