NCT01855373

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

3.7 years

First QC Date

May 13, 2013

Last Update Submit

April 14, 2016

Conditions

Blood SugarEndothelial Function

Keywords

Blood SugarEndothelial FunctionBlood Vessel Health

Outcome Measures

Primary Outcomes (1)

  • Mean change in plasma glucose

    90 days

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (4)

Placebo

OTHER

No active ingredient

Other: Placebo

PEAK ATP® with GlycoCarn®

ACTIVE COMPARATOR

Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)and Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule)

Dietary Supplement: PEAK ATP® with GlycoCarn®

PEAK ATP®

ACTIVE COMPARATOR

Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)

Dietary Supplement: PEAK ATP®

GlycoCarn®

ACTIVE COMPARATOR

Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule)

Dietary Supplement: GlycoCarn®

Interventions

PEAK ATP® with GlycoCarn®DIETARY_SUPPLEMENT

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® with GlycoCarn®
PEAK ATP®DIETARY_SUPPLEMENT

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

PEAK ATP®
GlycoCarn®DIETARY_SUPPLEMENT

GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach

GlycoCarn®
PlaceboOTHER

Placebo: 2 capsules twice daily on an empty stomach

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life Extension Clinical Research Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Related 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.

    PMID: 19008000BACKGROUND

  • 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.

    PMID: 15940776BACKGROUND

  • 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. doi: 10.1186/1550-2783-4-22.

    PMID: 18053183BACKGROUND

  • 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.

    PMID: 20209464BACKGROUND

  • 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.

    PMID: 21129239BACKGROUND

  • 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. doi: 10.1001/jama.282.17.1659.

    PMID: 10553793BACKGROUND

  • 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.

    BACKGROUND

  • Evans AM, Fornasini G. Pharmacokinetics of L-carnitine. Clin Pharmacokinet. 2003;42(11):941-67. doi: 10.2165/00003088-200342110-00002.

    PMID: 12908852BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 19341458BACKGROUND

  • 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. doi: 10.1249/01.mss.0000128198.97260.8b.

    PMID: 15179168BACKGROUND

  • Knowles JR. Enzyme-catalyzed phosphoryl transfer reactions. Annu Rev Biochem. 1980;49:877-919. doi: 10.1146/annurev.bi.49.070180.004305. No abstract available.

    PMID: 6250450BACKGROUND

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

    BACKGROUND

  • Tornroth-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. No abstract available.

    PMID: 19073922BACKGROUND

Study Officials

  • Steven Joyal, M.D.

    Life Extension

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 16, 2013

Study Start

July 1, 2012

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

US(1)