Blood Sugar, Endothelial Function
Conditions
Keywords
Blood Sugar, Endothelial Function, Blood Vessel Health
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.
Interventions
DIETARY_SUPPLEMENTPEAK 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
DIETARY_SUPPLEMENTPEAK ATP®
PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach
DIETARY_SUPPLEMENTGlycoCarn®
GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach
OTHERPlacebo
Placebo: 2 capsules twice daily on an empty stomach
Sponsors
Sigma Tau HealthScience LLC
TSI Health Sciences, Inc.
Supplement Formulators, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in plasma glucose | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Mean change in soluble Intercellular Adhesion Molecule-1 (sICAM-1) | 90 days |
| Mean change in E-Selectin blood level | 90 days |
| Mean change in flow-mediated dilation | 90 day |
| Mean change in Body Mass Index (BMI) | 90 days |
| Mean change in percent body fat | 90 days |
| Mean change in waist and hip circumference | 90 days |
| Mean change in blood pressure | 90 days |
| Assess the safety and tolerability as measured by various laboratory markers, vital signs and adverse events | 90 days |
| Mean change in body weight | 90 days |
Countries
United States
Outcome results
None listed