This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is:
What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide?
Participants will consume AMPK Charge+® with or without semaglutide injections and will be evaluated for glycemic response parameters.
Males & females between 18 years of age or older
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
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
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products
Personal or family history of MTC or in patients with MEN 2
Unstable metabolic disease or chronic diseases as assessed by the QI
Parallel
AMPK Charge+®
Dietary supplementParticipants will be instructed to consume 1 teaspoon (5 mL) on an empty stomach before breakfast and 1 teaspoon on an empty stomach in the afternoon and to hold the product in the mouth for approximately 30-90 seconds before swallowing starting on Day 1.
AMPK Charge+® with semaglutide
Dietary supplementParticipants will be instructed to use the provided measuring tool to take 1 teaspoon (5 mL) on an empty stomach before breakfast and 1 teaspoon on an empty stomach in the afternoon and to hold the product in the mouth for approximately 30-90 seconds before swallowing starting on Day 1. Participants will be instructed to administer subcutaneous semaglutide once per week beginning with a dose of 0.25 mg for four weeks at which point participants will be instructed to increase the dose to 0.5 mg per week for the remainder of the study period.
The difference in change in fasting blood glucose between AMPK Charge+® and AMPK Charge+® with semaglutide
The difference in change in fasting blood glucose from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide
The difference in change in fasting insulin between AMPK Charge+® and AMPK Charge+® with semaglutide
The difference in change in fasting insulin from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide
The difference in change in hemoglobin A1c (HbA1c) between AMPK Charge+® and AMPK Charge+® with semaglutide
The difference in change in hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting blood glucose
The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting blood glucose
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in HbA1c
The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting HbA1c
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting insulin
The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting insulin
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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QuickSilver Scientific
Lead sponsor
KGK Science Inc.
Collaborator
