Comparing Blood Sugar Levels and Endothelial Function of PEAK ATP® With GlycoCarn®, PEAK ATP® and GlycoCarn® Supplements
Condition: Blood Sugar; Endothelial Function
Study type: Interventional

Summary: 
      To purpose of this study is to assess the effectiveness, safety and tolerability of PEAK ATP®
      with GlycoCarn®, PEAK ATP® and GlycoCarn® on levels of blood sugar and endothelial function
      improvement which may lead to improved vascular health.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, parallel design to evaluate the
      effectiveness, safety and tolerability of the study substances utilized to support improved
      healthy levels of blood sugar and endothelial function. Each subject will be randomized to
      receive a specific dose of PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt)with GlycoCarn®
      (Glycine Propionyl-L-Carnitine Hydrochloride, USP (United States Pharmacopeia) , PEAK ATP®
      (Adenosine 5'-Triphosphate Disodium Salt) and GlycoCarn® (Glycine Propionyl-L-Carnitine
      Hydrochloride, USP )or Placebo twice daily.

      Participants will undergo assessment of blood tests, brachial ultrasound for determining the
      change in flow mediated dilation, body weight, % body fat, BMI, waist/hip circumference and
      blood pressure.

      The primary objective of the study is to evaluate the safety, tolerability and effectiveness
      of PEAK ATP® with GlycoCarn®, PEAK ATP® and GlycoCarn® on improving levels of blood sugar via
      assessment of plasma glucose.

      Secondary objectives:

        1. To assess flow-mediated dilation as determined by brachial ultrasound evaluation.

        2. To assess the effect on changes in blood levels of HbA1C, high-sensitivity C-Reactive
           Protein (hs-CRP), Insulin, Nitric Oxide (NOx), Malondialdehyde (MAL), Soluble
           Inter-cellular Adhesion Molecule-1 (sICAM-1) and E-Selectin.

        3. To assess the effect on body weight, Body Mass Index (BMI), % body fat as measured by
           skin caliper, waist and hip circumference, and blood pressure.

        4. To assess the effect on general and sexual health for males and females as determined
           through questionnaires.
    

Intervention name(s): PEAK ATP® with GlycoCarn®; PEAK ATP®; GlycoCarn®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): PEAK ATP® with GlycoCarn® {Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule) and Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)}: 2 capsules twice daily on an empty stomach; PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach; GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach; Placebo: 2 capsules twice daily on an empty stomach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Blood Sugar; Endothelial Function; Blood Vessel Health