Status:
COMPLETED
Comparing Blood Sugar Levels and Endothelial Function of PEAK ATP® With GlycoCarn®, PEAK ATP® and GlycoCarn® Supplements
Lead Sponsor:
Supplement Formulators, Inc.
Collaborating Sponsors:
Sigma Tau HealthScience LLC
TSI Health Sciences, Inc.
Conditions:
Blood Sugar
Endothelial Function
Eligibility:
All Genders
25-65 years
Phase:
NA
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 wh...
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...
Eligibility Criteria
Inclusion
- Primary
- 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
- Primary
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01855373
Start Date
July 1 2012
End Date
April 1 2016
Last Update
April 15 2016
Active Locations (1)
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1
Life Extension Clinical Research Inc.
Fort Lauderdale, Florida, United States, 33308