Clinical Review for Gluco Low and Vita Power
The Safety and Efficacy of Gluco Low (serum sugar modulator) and Vita Power Dietary Supplements
in Type II Diabetes Mellitus
This prospective, randomized, placebo-controlled, double-blind clinical trial on the efficacy and safety of Gluco-Low and Vita Power was completed in May of 2009. Upon the recommendation of several editorial reviews, the investigators agreed to add a new phase of examination to the clinical trial by assessing the dysfunction of neuropathic pain on the participants in the study. This phase will commence testing on January 5, 2010. The purpose of the clinical study was to test the efficacy and safety of Gluco-Low and Vita Power by assessing thirst, frequent urination, hunger, weight loss, fatigue, blurred vision, diplopia (double vision), and frequent infections.
Investigators (Khano et al) examined the following laboratory tests during the clinical trial:
1. CBC (Complete Blood Count).
2. Random blood sugar test: Blood samples were taken at random. A random blood sugar level of 200 milligrams per deciliter (mg/dL) or higher will always suggest diabetes whether measured after food intake or fasting.
3. Fasting blood sugar test: Blood samples were taken after an overnight fast. A fasting blood sugar level between 70 and 100 mg/dL is normal. A fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes, which indicates a high risk of developing diabetes; a level of 126 mg/dL or higher on two separate tests is the standard confirmation for a diagnosis of diabetes.
4. Glycated hemoglobin test: A glycated hemoglobin test, also called a glycosylated hemoglobin test or hemoglobin A1C test, reflects the average blood sugar level for the two to three-month period before the test. This test was administered to determine each subject’s management of blood sugar levels.
5. Serum creatinine test: This test is used to evaluate kidney health and function. It measures the blood level of creatinine, a chemical waste product of muscle function. If the kidneys aren't working properly, there is an excess level of creatinine in the blood.
6. Urine microalbumin test: A urine microalbumin test assesses the kidney function by screening the urine for protein. Damaged kidneys do not filter waste products efficiently, leaving excess protein (albumin) in the blood that is leaked into the urine.
7. Lipids test: A lipids test measures the level of fat (lipids) in the blood. A rising level of certain blood fats increases the risk of blood vessel damage. The test measures slow-density lipoprotein (LDL, or the "bad" cholesterol) and triglycerides; elevated levels increase the risk of cardiovascular disease. The test also determines the level of high-density lipoprotein (HDL, or the "good" cholesterol), which protects against heart disease.
Materials and methods
60 subjects under went randomization and were divided into two groups: one group received the active investigational product (Gluco-Low and Vita Power), the other group received a placebo with a non-active recipient. The duration of the study trial was 90 days. Patients were screened to meet inclusion and exclusion criteria for the study protocol. Three follow-up visits were scheduled at week 4, week 8, and week 12 to ascertain the subjects' symptoms and physical findings.
The protocol of 800mg of Gluco-low supplements QID (4 times daily) and 800mg of Vita Power BID (twice daily) demonstrated a significant improvement in the above-stated symptoms. Specific test findings which corroborated and supported these improvements will be available upon publication. Moreover, investigators didn't find or report adverse events from the ingestion of the investigational protocol.
Charlie Khano, MD. Internal Medicine, Nephrologists, Private Practice, Union City, CA
Judy Weinberg, MD. Internal Medicine, Endocrinologist, University of Pennsylvania School of Medicine, Philadelphia, PA.
Andy Winstin, MD. Internal Medicine, Endocrinologist, Private Practice, San Francisco, CA
Phillip Shinnick, D.C., Ph.D., Wythe Research Institute of Global Physiology, Behavior, and Treatment, INC., NY, NY
Cindy Maloore, Ph.D., Nutritionist, Private Practice, Santa Clara, CA