--- title: "Safety & Tolerability" description: "Gut-local by design. Evaluated directly in human research. Generally well tolerated across the SiPore® evidence base." url: "https://sipore.com/science/safety-tolerability" canonical: "https://sipore.com/science/safety-tolerability" markdown_url: "https://sipore.com/science/safety-tolerability.md" site: "SiPore" publisher: "SiPore Technologies (Sigrid Therapeutics AB)" language: "en" updated: "2026-10-02" --- # Safety & Tolerability > Gut-local by design. Evaluated directly in human research. Generally well tolerated across the SiPore® evidence base. *SAFETY & TOLERABILITY* ## Gut-local by design. Generally well tolerated in human research. SiPore® is designed to perform its function locally in the gastrointestinal tract, where digestion happens. It does not enter the bloodstream. Safety and tolerability have been evaluated across the human SiPore® research program, including dedicated safety research and a large randomized, placebo-controlled clinical trial. Across the evidence base, SiPore® has been generally well tolerated. [Explore the safety evidence →](#safety-evidence) *FOUR IMMEDIATE FACTS* - GUT-LOCAL — Works in the gastrointestinal tract. - NON-SYSTEMIC — Does not enter the bloodstream. - HUMAN STUDIED — Safety and tolerability evaluated in clinical research. - GENERALLY WELL TOLERATED — Across the human research program. *LOCAL MODE OF ACTION* ### Designed to work where digestion happens. SiPore® is based on precisely engineered porous silica particles. During digestion, the particles remain within the gastrointestinal tract, where their pores interact with digestive enzymes involved in breaking down carbohydrates and fats. SiPore® does not need to enter the bloodstream to perform its function. Its action is physical and local rather than systemic. - GI tract — SiPore® acts here - Bloodstream — SiPore® does not enter *MICRON-SIZED BY DESIGN* ### Why SiPore® remains gut-local. Micron-sized particles support a gut-local mode of action. SiPore® particles are micron-sized. Research examining mesoporous silica particles as they passed through the gastrointestinal tract found that the particles retained their structure and supported the conclusion that their lack of systemic absorption is related to their micron-scale size. - Small molecule - Digestive enzyme - Micron-sized SiPore® particle The study examined particle structure and behavior during passage through the gastrointestinal tract and reported that the particles were not degraded during transit. - Iqbal et al., 2023 **Mesoporous Silica Particles Retain Their Structure and Function while Passing through the Gastrointestinal Tracts of Mice and Humans** ACS Applied Materials & Interfaces, 2023 [View publication](https://doi.org/10.1021/acsami.2c16710) *SCIENTIFIC RIGOR* ### Safety has been studied separately from the mechanism. Gut-local action is a property of the technology. Safety is evaluated through evidence. The fact that SiPore® works locally does not, by itself, establish safety. That is why safety and tolerability have also been evaluated directly in human clinical studies. > **Where SiPore® works and how SiPore® has been tolerated are two related but distinct parts of the scientific story.** *HUMAN SAFETY RESEARCH* ### From dedicated safety evaluation to the largest SiPore® trial. Across the current human evidence base, reported adverse events have primarily been mild and transient gastrointestinal symptoms. - First-in-Man — Dedicated human safety study - STAR — Proof-of-concept clinical study - SHINE — Large randomized clinical trial - Real-World Evidence — Continued observation of tolerability in everyday use SHINE is the largest SiPore® clinical trial conducted to date. Safety and tolerability were assessed throughout the study, and SiPore® was generally well tolerated in the studied population. #### SHINE - DEDICATED HUMAN SAFETY STUDY — First-in-Man — N = 20 • Male participants • Oral mesoporous silica - PROOF-OF-CONCEPT CLINICAL STUDY — STAR — N = 43 • Prediabetes or newly diagnosed type 2 diabetes [Read the paper →](https://sipore.com/docs/shine-trial) *TOLERABILITY* ### What “generally well tolerated” means. What was reported? “Generally well tolerated” does not mean that no adverse events can occur. Across the human research program, reported tolerability findings have primarily involved gastrointestinal symptoms that were mild and transient. - Primarily mild — The current evidence base describes most reported adverse events as mild rather than serious. - Gastrointestinal — GI symptoms are the most relevant tolerability events reported across the current evidence base. - Generally transient — Reported gastrointestinal events were generally temporary rather than persistent. - Continue to monitor — Safety and tolerability remain part of the clinical and real-world evidence program as the evidence base expands. *SAFETY MONITORING* ### More than adverse-event reporting. Clinical safety evaluation considers more than whether participants report symptoms. Across the SiPore® clinical program, safety assessments have included clinical observations and laboratory measures designed to identify potential systemic effects. - **CLINICAL SAFETY** — Adverse events & vital signs — Clinical observations used to identify tolerability issues and changes in general health status. - **LABORATORY SAFETY** — Blood & organ function — Hematology and relevant liver and renal markers have been included in safety monitoring. - **NUTRITIONAL STATUS** — Vitamins & minerals — Selected vitamin and mineral markers have been monitored in clinical research. ### Does SiPore® interfere with vitamins and minerals? #### What has clinical monitoring shown? Because SiPore® acts during digestion, it is reasonable to ask whether it also affects micronutrient status. Internal clinical evidence supplied for this page reports no significant changes in measured vitamin or mineral levels across the evaluated clinical studies, including monitoring of vitamin D and selected vitamin and mineral markers. *PRODUCT-SPECIFIC USE* ### Medication timing and suitability belong with the finished product. Taking a SiPore®-powered product? Directions, medication timing, contraindications and suitability can differ by finished product and regulatory classification. Always follow the instructions provided with the specific product. [Consumer products →](https://sigridlife.com) [Healthcare professional products →](https://siporepro.com) *EVIDENCE IN ONE VIEW* ### Safety has been evaluated at multiple stages of the program. The U.S. real-world evidence study also reported good tolerability and high adherence in everyday use. - MECHANISM RESEARCH — Supports a gut-local, non-systemic mode of action. - FIRST-IN-MAN — Dedicated human safety and tolerability evaluation. - STAR + SHINE — Safety and tolerability evaluated alongside clinical outcomes. - REAL-WORLD EVIDENCE — Continued observation of tolerability in everyday use. *OUR APPROACH TO SAFETY* ### Safety claims should be as precise as the science behind them. SiPore.com does not use absolute safety language. Instead, we present: where SiPore® works, how it has been studied, what was observed, and the limits of the available evidence. That means using “generally well tolerated” when describing the overall evidence base and providing study-specific detail where appropriate. *RELATED SCIENCE* ### Continue exploring. - **RESEARCH & EVIDENCE** — Complete evidence program — Explore clinical, real-world, consumer and preclinical research. - **PUBLICATIONS** — Peer-reviewed science — Browse the scientific literature behind SiPore®. - **SCIENTIFIC FAQ** — Common science questions — Find clear answers about mechanism, evidence and safety. - **TECHNOLOGY** — How SiPore® works — Return to the gut-local mechanism and engineered particle story. ### Gut-local by design. Evaluated in people. **SiPore® works locally in the gastrointestinal tract and does not enter the bloodstream. Across human clinical research, it has been generally well tolerated.** [Explore Research & Evidence →](https://sipore.com/science/research-evidence) [View Publications →](https://sipore.com/science/publications) ## How to cite SiPore Technologies (Sigrid Therapeutics AB). “Safety & Tolerability”. SiPore, 2026-10-02. https://sipore.com/science/safety-tolerability (accessed ). Use the trademarks as written: SiPore®, Carb Fence™. For the SHINE trial, cite the peer-reviewed publication in *eClinicalMedicine* (The Lancet Discovery Science, 2026) rather than this page. ## Company & contact - **Company:** SiPore Technologies — legal entity Sigrid Therapeutics AB (Swedish org.nr [556958-3023](https://www.allabolag.se/foretag/sigrid-therapeutics-ab/sundbyberg/forskning/2K3ZHRJI5YE3M)) - **Stockholm headquarters:** Vasagatan 14A, 172 61 Sundbyberg, Sweden ([map](https://www.google.com/maps/search/?api=1&query=Vasagatan%2014A%2C%20172%2061%20Sundbyberg%2C%20Sweden)) - **General enquiries:** [contact@sipore.com](mailto:contact@sipore.com) - **Partnerships & licensing:** [partnerships@sipore.com](mailto:partnerships@sipore.com) - **Origin:** Founded in Stockholm, Sweden - **Taglines:** “The meal companion for modern food.” · “Same meal. Less impact.” · “Scandinavian science. Global impact.” · “Precision science for the modern meal.” - **About:** SiPore® is a patented meal-companion technology designed to reduce the impact of modern meals at the level of digestion. **Our sites** — all sites owned and operated by Sigrid Therapeutics AB: - [SiPore.com](https://www.sipore.com/): Technology, science & partnerships - [SiPorePro.com](https://www.siporepro.com/): Practitioner products & professional resources - [SigridLife.com](https://sigridlife.com/): SIGRID consumer products - [SigridStabiliser.se](https://sigridstabiliser.se/): SIGRID Sweden --- [View on site](https://sipore.com/science/safety-tolerability) · [Site index for agents (llms.txt)](https://sipore.com/llms.txt)