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

Study Overview
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Brief Summary
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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
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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: To assess flow-mediated dilation as determined by brachial ultrasound evaluation. 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. 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. To assess the effect on general and sexual health for males and females as determined through questionnaires.

Official Title
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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

Conditions
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Blood Sugar, Endothelial Function

Intervention / Treatment
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* Dietary Supplement: PEAK ATP® with GlycoCarn®
* Dietary Supplement: PEAK ATP®
* Dietary Supplement: GlycoCarn®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Ambulatory Having the following two criteria: Confirmed as being overweight (BMI of 25.0-39.9) Confirmed by a baseline fasting blood sugar level between 95.0-125.0 mg/dl with the glucose meter via finger stick OR laboratory evaluation of glucose level between 95.0-125.0 mg/dl Having no difficulty with digestion or absorption of food Primary Exclusion Criteria: Having ever received a clinical diagnosis of cardiovascular disease (excluding hypertension), cancer (excluding basal or squamous cell skin cancer), autoimmune disease (such as systemic lupus, rheumatoid arthritis, multiple sclerosis, psoriasis, etc.), gout, seizures, liver or kidney disease, gallbladder disease, thyroid disease, bi-polar disorder, manic depression, schizophrenia, apathetic (inherited) depression, or any other diagnosis that would preclude study participation in the judgment of the investigator/sub-investigator. Having ever received a diagnosis of diabetes mellitus, glucose intolerance, or currently taking any medications for either of the aforementioned conditions. Having ever had a re-vascularization procedure (bypass, angioplasty or stent placement) or having received an organ transplant, pacemaker, or internal medical device. Currently receiving hormone replacement therapy or taking phosphodiesterase type-5 (PDE-5) inhibitors such as Sildenafil, Vardenafil and Tadalafil. If taking aspirin, ibuprofen, naproxen or other anti-inflammatory medication(s), cholesterol medications (including statins), an oral contraceptive, blood pressure medications or medications to treat congestive heart failure (including ACE inhibitors, ACE antagonists or diuretics), must have been on a stable dose for greater than 3 months prior to baseline and be willing to remain on stable dose for duration of study. If taking any other cardiovascular drugs including but not limited to antiarrhythmics (excluding beta blockers), inotropic agents, antianginals, or digitalis. Having had a history of any medical or surgical procedure that would preclude participation in the study in the judgment of the investigator/sub- investigator. Having any blood coagulation disorder or vitamin K deficiency. History of allergy to any nutritional supplements, herbal remedies, foods, or any of the components in the study products. Have no clinically significant abnormalities on the basis of medical history, physical examination, laboratory evaluation and vital signs in the judgment of the investigator and/or sub-investigator.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo<br>No active ingredient | Other: Placebo<br>* Placebo: 2 capsules twice daily on an empty stomach<br>|
| Active Comparator: PEAK ATP® with GlycoCarn®<br>Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)and Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule) | Dietary Supplement: PEAK ATP® with GlycoCarn®<br>* 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<br>|
| Active Comparator: PEAK ATP®<br>Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule) | Dietary Supplement: PEAK ATP®<br>* PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach<br>|
| Active Comparator: GlycoCarn®<br>Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule) | Dietary Supplement: GlycoCarn®<br>* GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in plasma glucose |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in flow-mediated dilation |  | 90 day | 
| Mean change in HbA1C |  | 90 days | 
| Mean change in high-sensitivity C-Reactive Protein (hs-CRP) |  | 90 days | 
| Mean change in insulin level |  | 90 days | 
| Mean change in Malondialdehyde level |  | 90 day | 
| Mean change in soluble Intercellular Adhesion Molecule-1 (sICAM-1) |  | 90 days | 
| Mean change in E-Selectin blood level |  | 90 days | 
| Mean change in body weight |  | 90 days | 
| Mean change in Body Mass Index (BMI) |  | 90 days | 
| Mean change in percent body fat |  | 90 days | 
| Mean change in waist and hip circumference |  | 90 days | 
| Mean change in blood pressure |  | 90 days | 
| Assess the safety and tolerability as measured by various laboratory markers, vital signs and adverse events |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Sugar, Endothelial Function, Blood Vessel Health