NCT01855373

Comparing Blood Sugar Levels and Endothelial Function of PEAK ATP® With GlycoCarn®, PEAK ATP® and GlycoCarn® Supplements

A Randomized, Double-blind, Placebo-controlled Study Comparing the Healthy Levels of Blood Sugar and Endothelial Function of PEAK ATP® With GlycoCarn®, PEAK ATP® and GlycoCarn® Supplementation Versus Placebo

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Sugar
• Endothelial Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PEAK ATP® with GlycoCarn®	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
DIETARY_SUPPLEMENT	PEAK ATP®	PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach
DIETARY_SUPPLEMENT	GlycoCarn®	GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach
OTHER	Placebo	Placebo: 2 capsules twice daily on an empty stomach

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2013-05-16
• Last updated: 2016-04-15

Locations

1 site across 1 country: United States