A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes

Sponsor
QuickSilver Scientific
Study ID
NCT07195994
Status
Recruiting
Apply to this trial

Conditions

  • Prediabetes / Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMPK Charge+® — DIETARY_SUPPLEMENT
    Participants 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_SUPPLEMENT
    Participants 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.

Study Details

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.

Key Dates

Start date
Feb 5, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AMPK Charge+®
    AMPK Charge+® is a dietary supplement comprised of highly purified phospholipids, diindolylmethane, quercetin dihydrate, milk thistle seed extract, resveratrol, and berberine delivered using liposomal and nanoemulsion technology.
  • Active Comparator: AMPK Charge+® with semaglutide
    Subcutaneous semaglutide (Ozempic®), a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for adults with T2D to improve glycemic control with the safety and efficacy extensively investigated leading to approvals by the United States (U.S.) Food and Drug Administration and Health Canada

Primary Outcome Measure

The difference in change in fasting blood glucose between AMPK Charge+® and AMPK Charge+® with semaglutide [ Time Frame: Day 0 to 84 ]

Central Contacts

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