Trial record 2 of 127 for:    Open Studies | "Blood Glucose"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Supplement Formulators, Inc.
Sponsor:
Collaborators:
Sigma Tau HealthScience LLC
TSI Health Sciences Inc.
Information provided by (Responsible Party):
Supplement Formulators, Inc.
ClinicalTrials.gov Identifier:
NCT01855373
First received: May 13, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Blood Sugar
Endothelial Function
Dietary Supplement: PEAK ATP® with GlycoCarn®
Dietary Supplement: PEAK ATP®
Dietary Supplement: GlycoCarn®
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by Supplement Formulators, Inc.:

Primary Outcome Measures:
  • Mean change in plasma glucose [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo
No active ingredient
Other: Placebo
Placebo: 2 capsules twice daily on an empty stomach
Active Comparator: PEAK ATP® with GlycoCarn®
Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)and Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule)
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
Active Comparator: PEAK ATP®
Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)
Dietary Supplement: PEAK ATP®
PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach
Active Comparator: GlycoCarn®
Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule)
Dietary Supplement: GlycoCarn®
GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach

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.
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855373

Contacts
Contact: Dr. Steven Hirsh 954-202-7679 shirsh@lifeextension.com

Locations
United States, Florida
Life Extension Clinical Research Inc. Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Iliana Nin, CCRC    954-202-7737    inin@lifeextension.com   
Contact: Dr. Steven Hirsh    954-202-7679    shirsh@lifeextension.com   
Sponsors and Collaborators
Supplement Formulators, Inc.
Sigma Tau HealthScience LLC
TSI Health Sciences Inc.
Investigators
Principal Investigator: Steven Joyal, M.D. Life Extension
  More Information

Publications:
Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT01855373     History of Changes
Other Study ID Numbers: CL049
Study First Received: May 13, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Supplement Formulators, Inc.:
Blood Sugar
Endothelial Function
Blood Vessel Health

ClinicalTrials.gov processed this record on September 29, 2014