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Blood SugarNCT01855373

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

A study testing PEAK ATP® with GlycoCarn®, PEAK ATP® and GlycoCarn® in people with Blood Sugar and Endothelial Function, run by Supplement Formulators, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Blood Sugar, Endothelial Function
What is being tested?
PEAK ATP® with GlycoCarn®, PEAK ATP® and GlycoCarn®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 2012to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Life Extension Clinical Research Inc.

    Fort Lauderdale, Florida, 33308

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
PEAK ATP® with GlycoCarn®, PEAK ATP®, GlycoCarn®, Placebo
Keywords
Blood Sugar, Endothelial Function, Blood Vessel Health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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®Dietary supplement

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

  • GlycoCarn®Dietary supplement

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

  • PlaceboOther

    Placebo: 2 capsules twice daily on an empty stomach

Study groups in NCT01855373
Study groupRoleWhat they receive
PlaceboOtherNo active ingredient
Receives: Other: Placebo
PEAK ATP® with GlycoCarn®Active comparatorAdenosine 5'-Triphosphate Disodium Salt (100mg/capsule)and Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule)
Receives: Dietary Supplement: PEAK ATP® with GlycoCarn®
PEAK ATP®Active comparatorAdenosine 5'-Triphosphate Disodium Salt (100mg/capsule)
Receives: Dietary Supplement: PEAK ATP®
GlycoCarn®Active comparatorGlycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule)
Receives: Dietary Supplement: GlycoCarn®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in plasma glucose

    Measured: 90 days

Secondary outcomes (13)

  1. Mean change in flow-mediated dilation

    Measured: 90 day

  2. Mean change in HbA1C

    Measured: 90 days

  3. Mean change in high-sensitivity C-Reactive Protein (hs-CRP)

    Measured: 90 days

  4. Mean change in insulin level

    Measured: 90 days

  5. Mean change in Malondialdehyde level

    Measured: 90 day

  6. Mean change in soluble Intercellular Adhesion Molecule-1 (sICAM-1)

    Measured: 90 days

  7. Mean change in E-Selectin blood level

    Measured: 90 days

  8. Mean change in body weight

    Measured: 90 days

  9. Mean change in Body Mass Index (BMI)

    Measured: 90 days

  10. Mean change in percent body fat

    Measured: 90 days

  11. Mean change in waist and hip circumference

    Measured: 90 days

  12. Mean change in blood pressure

    Measured: 90 days

  13. Assess the safety and tolerability as measured by various laboratory markers, vital signs and adverse events

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855373
Sponsor's protocol ID
CL049
Status last verified
Apr 2016
First submitted
13 May 2013
Last updated
15 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19008000

  • 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.

    PubMed 15940776

  • 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.

    PubMed 18053183

  • 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.

    PubMed 20209464

  • 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.

    PubMed 21129239

  • 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.

    PubMed 10553793

  • 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. doi: 10.2165/00003088-200342110-00002.

    PubMed 12908852

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

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

  • 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.

    PubMed 19341458

  • 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.

    PubMed 15179168

  • 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.

    PubMed 6250450

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

Questions about this trial

What is this clinical trial studying?

A study testing PEAK ATP® with GlycoCarn®, PEAK ATP® and GlycoCarn® in people with Blood Sugar and Endothelial Function, run by Supplement Formulators, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in plasma glucose (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855373, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.

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