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

Endothelial Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855373
• Other study ID #: CL049
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: April 14, 2016
• Start date: July 2012
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Supplement Formulators, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Primary Inclusion Criteria:

• Ambulatory

• Having the following two criteria:

1. Confirmed as being overweight (BMI of 25.0-39.9)

2. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Blood Sugar
• Endothelial Function

Intervention

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
• PEAK ATP®
PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach
• 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

Locations

Country	Name	City	State
United States	Life Extension Clinical Research Inc.	Fort Lauderdale	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Supplement Formulators, Inc.	Sigma Tau HealthScience LLC, TSI Health Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (16)

Abbracchio MP, Burnstock G, Verkhratsky A, Zimmermann H. Purinergic signalling in the nervous system: an overview. Trends Neurosci. 2009 Jan;32(1):19-29. doi: 10.1016/j.tins.2008.10.001. Epub 2008 Nov 12. Review. — View Citation

Bannwarth B, Allaert FA, Avouac B, Rossignol M, Rozenberg S, Valat JP. A randomized, double-blind, placebo controlled triphosphate in study of oral adenosine subacute low back pain. J Rheumatol. 2005 Jun;32(6):1114-7. — View Citation

Bloomer RJ, Smith WA, Fisher-Wellman KH. Glycine propionyl-L-carnitine increases plasma nitrate/nitrite in resistance trained men. J Int Soc Sports Nutr. 2007 Dec 3;4:22. — View Citation

Bloomer RJ, Tschume LC, Smith WA. Glycine propionyl-L-carnitine modulates lipid peroxidation and nitric oxide in human subjects. Int J Vitam Nutr Res. 2009 May;79(3):131-41. doi: 10.1024/0300-9831.79.3.131. — View Citation

Coolen EJ, Arts IC, Bekers O, Vervaet C, Bast A, Dagnelie PC. Oral bioavailability of ATP after prolonged administration. Br J Nutr. 2011 Feb;105(3):357-66. doi: 10.1017/S0007114510003570. Epub 2010 Dec 6. — View Citation

Cortez-Pinto H, Chatham J, Chacko VP, Arnold C, Rashid A, Diehl AM. Alterations in liver ATP homeostasis in human nonalcoholic steatohepatitis: a pilot study. JAMA. 1999 Nov 3;282(17):1659-64. — View Citation

Di Carlo, S. E. and Collins, H. L. (June 1, 2001). Submitting illuminations for review. Advan. Physiol.Edu. 25 (2):70-1. http://advan.physiology.org/ cgi/content/full/25/2/70.

Evans AM, Fornasini G. Pharmacokinetics of L-carnitine. Clin Pharmacokinet. 2003;42(11):941-67. Review. — View Citation

http://naturaldatabase.therapeuticresearch.com/nd/Search.aspx?pt=100&id=803&fs=ND&searchid=27239640&cs=&s=ND

http://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html.

http://www.pharmgkb.org/do/serve?objId=PA164743471&objCls=Drug#tabview=tab1.

Jacobs PL, Goldstein ER, Blackburn W, Orem I, Hughes JJ. Glycine propionyl-L-carnitine produces enhanced anaerobic work capacity with reduced lactate accumulation in resistance trained males. J Int Soc Sports Nutr. 2009 Apr 2;6:9. doi: 10.1186/1550-2783-6-9. — View Citation

Jordan AN, Jurca R, Abraham EH, Salikhova A, Mann JK, Morss GM, Church TS, Lucia A, Earnest CP. Effects of oral ATP supplementation on anaerobic power and muscular strength. Med Sci Sports Exerc. 2004 Jun;36(6):983-90. — View Citation

Knowles JR. Enzyme-catalyzed phosphoryl transfer reactions. Annu Rev Biochem. 1980;49:877-919. Review. — View Citation

Mace, A.E. (1964), Sample Size Determination, New York: Reinhold Publishing Corporation.

Törnroth-Horsefield S, Neutze R. Opening and closing the metabolite gate. Proc Natl Acad Sci U S A. 2008 Dec 16;105(50):19565-6. doi: 10.1073/pnas.0810654106. Epub 2008 Dec 10. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in plasma glucose		90 days	No
Secondary	Mean change in flow-mediated dilation		90 day	No
Secondary	Mean change in HbA1C		90 days	No
Secondary	Mean change in high-sensitivity C-Reactive Protein (hs-CRP)		90 days	No
Secondary	Mean change in insulin level		90 days	No
Secondary	Mean change in Malondialdehyde level		90 day	No
Secondary	Mean change in soluble Intercellular Adhesion Molecule-1 (sICAM-1)		90 days	No
Secondary	Mean change in E-Selectin blood level		90 days	No
Secondary	Mean change in body weight		90 days	No
Secondary	Mean change in Body Mass Index (BMI)		90 days	No
Secondary	Mean change in percent body fat		90 days	No
Secondary	Mean change in waist and hip circumference		90 days	No
Secondary	Mean change in blood pressure		90 days	No
Secondary	Assess the safety and tolerability as measured by various laboratory markers, vital signs and adverse events		90 days	No