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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
60
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
Life Extension Clinical Research Inc.
Fort Lauderdale, Florida, United States
Mean change in plasma glucose
Time frame: 90 days
Mean change in flow-mediated dilation
Time frame: 90 day
Mean change in HbA1C
Time frame: 90 days
Mean change in high-sensitivity C-Reactive Protein (hs-CRP)
Time frame: 90 days
Mean change in insulin level
Time frame: 90 days
Mean change in Malondialdehyde level
Time frame: 90 day
Mean change in soluble Intercellular Adhesion Molecule-1 (sICAM-1)
Time frame: 90 days
Mean change in E-Selectin blood level
Time frame: 90 days
Mean change in body weight
Time frame: 90 days
Mean change in Body Mass Index (BMI)
Time frame: 90 days
Mean change in percent body fat
Time frame: 90 days
Mean change in waist and hip circumference
Time frame: 90 days
Mean change in blood pressure
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Placebo: 2 capsules twice daily on an empty stomach
Time frame: 90 days
Assess the safety and tolerability as measured by various laboratory markers, vital signs and adverse events
Time frame: 90 days