Amai Proteins, a scale-up designer of novel proteins that answer the needs of consumers and industry, has succesfullly completed world’s first double-blind, random clinical trial on the effects of their proprietary hyper-sweet protein, sweelin®, on blood glucose and insulin levels in humans.
The study demonstrated that sweelin® neither raises blood glucose nor blood insulin levels in healthy adults even after consuming an amount equivalent to the sweetness of 75 grams of sugar (in the form of glucose).
Although not required by regulatory authorities, Amai Proteins decided to conduct this study to boost consumer and market confidence in the safety and health profile of sweelin®. The study provides validated evidence of the beneficial effects of sweelin® on consumer’s health. sweelin® can help consumers globally who are trying to reduce added sugars in their diet but don’t want to compromise on taste or health.
The study was conducted at the Phase 1 Clinical Research Center (CRC) of Tel Aviv Sourasky Medical Center, under strict Good Clinical Practice (GCP) standards. Twenty eligible healthy volunteers completed the screening process and participated in the study.
All participants made three visits to the medical center. During each visit, the participants consumed one of three test beverages sweetened by either sweelin®, glucose, or stevia in a crossover double-blind, randomized controlled manner. All beverages were matched for sweetness intensity, with their dosage aligned to the sweetness equivalent of 75 grams of glucose, as used in a standard Oral Glucose Tolerance Test (OGTT). The study monitored the participants’ response to the test beverages for 120 minutes after consumption, measuring postprandial blood glucose and insulin levels.
All the participants successfully completed the study with no test-item-related adverse events, and no dropouts.
For the first time, this study by Amai proteins confirmed that a high dose of sweelin®, which can be labelled as ‘serendipity berry sweet protein’, does not impact blood glucose or insulin levels in healthy individuals.
