Clinical trial NCT01855373: Comparing Blood Sugar Levels and Endothelial Function of PEAK ATP® With GlycoCarn®, PEAK ATP® and GlycoCarn® Supplements
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sugar
Endothelial Function
Keywords: Blood Sugar
Endothelial Function
Blood Vessel Health
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sigma Tau HealthScience LLC
name: TSI Health Sciences, Inc.
First posted: 2013-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Primary outcomes:
measure: Mean change in plasma glucose
timeFrame: 90 days
Secondary outcomes:
measure: Mean change in flow-mediated dilation
timeFrame: 90 day
measure: Mean change in HbA1C
timeFrame: 90 days
measure: Mean change in high-sensitivity C-Reactive Protein (hs-CRP)
timeFrame: 90 days
measure: Mean change in insulin level
timeFrame: 90 days
measure: Mean change in Malondialdehyde level
timeFrame: 90 day
measure: Mean change in soluble Intercellular Adhesion Molecule-1 (sICAM-1)
timeFrame: 90 days
measure: Mean change in E-Selectin blood level
timeFrame: 90 days
measure: Mean change in body weight
timeFrame: 90 days
measure: Mean change in Body Mass Index (BMI)
timeFrame: 90 days
measure: Mean change in percent body fat
timeFrame: 90 days
measure: Mean change in waist and hip circumference
timeFrame: 90 days
measure: Mean change in blood pressure
timeFrame: 90 days
measure: Assess the safety and tolerability as measured by various laboratory markers, vital signs and adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Life Extension Clinical Research Inc.
state: Florida
Study officials:
affiliation: Life Extension
name: Steven Joyal, M.D.
role: PRINCIPAL_INVESTIGATOR
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