We often get questions about the “Clinically Proven” text on the PharmaPure Sugar Blocker label. We’re asked “Is PharmaPure Sugar Blocker really Clinically Proven?” and “Can you tell us about the study? The answers to both questions are Yes and Yes.
PharmaPure Sugar Blocker Clinically Proven Study Design
The study was independently conducted by a reputable laboratory owned and operated by a PhD and his team in February 2020. It was done in the United States. This was a randomized, double-blind, placebo-controlled, 2-arm parallel study to evaluate the efficacy of PharmaPure Sugar Blocker in sugar craving on parameters of Hydrogen Breath Test as measure of carbohydrate absorption and sugar craving in the presence or absence of PharmaPure Sugar Blocker.
The study was comprised of thirty participants that had to be screened for qualification purposes. This study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in CFR 21, part 50 (Protection of Human Subjects Informed Consent).
All sampling was performed by trained staff.
Sugar Blocker Study Testing Methodology
For Sugar Cravings: Breath samples were analyzed after each collection using calibrated equipment, with results recorded immediately into each subject record. The duration of the study for each subject was approximately 3 to 4 hours including the screening period.
The screening period was a maximum of 1 hour for eligibility determination, followed by a baseline measurement followed by a 3-hour experimentation period for breath and blood sampling. The subjects could not be on antibiotic therapy, bismuth products, antimicrobial herbals* (i.e. berberine, oregano oil) or probiotics, bowel purgatives or Laxatives before the test.
For Reduction Of Sugar Absorption: Fifteen of the participants were given 25 Grams of Glucose dissolved in 100ml of water in addition to Sugar Blocker and the other fifteen participants were given a placebo, containing only 25 Grams of Glucose in 100 ml of water.
Blood was drawn at 30 minute intervals for three hours. Blood samples were taken from capillary and venous points.
Sugar Blocker “Clinically Proven” Study Conclusions
Under the conditions of this study, the test material, PharmaPure Sugar Blocker demonstrated efficacy to reduce sugar absorption. Hydrogen levels collected from breath samples of subjects ingesting the test material were consistent with that expected for sugar blockage.
Hydrogen increases were detected at 120, 150 and 180 minutes after treatment with glucose and the test material, while hydrogen levels decreased at all time points for the test group receiving only glucose.
This efficacy in blocking sugar absorption was supported by glucose levels in capillary and venous blood. Spikes in glucose levels in the capillaries were much lower, absent or decreased in the group receiving treatment with PharmaPure Sugar Blocker relative to the untreated control group receiving only glucose.
For more information about the Sugar Blocker Clinically Proven Study, please contact PureTek Corporation.