--- title: "Research & Evidence" description: "The SiPore® evidence overview: clinical studies, real-world evidence, consumer studies and preclinical research — each clearly labelled." url: "https://sipore.com/science/research-evidence" canonical: "https://sipore.com/science/research-evidence" markdown_url: "https://sipore.com/science/research-evidence.md" site: "SiPore" publisher: "SiPore Technologies (Sigrid Therapeutics AB)" language: "en" updated: "2026-10-02" --- # Research & Evidence > The SiPore® evidence overview: clinical studies, real-world evidence, consumer studies and preclinical research — each clearly labelled. *RESEARCH & EVIDENCE* ## From mechanism to human evidence. SiPore® has been investigated across the research continuum: from preclinical studies exploring how the technology works, through controlled human clinical trials, to real-world evidence and consumer research. Together, these studies build a growing understanding of how SiPore® works, how it performs in human research, and what people report experiencing in everyday use. - 15+ — YEARS OF RESEARCH - 6 — CLINICAL TRIALS - 9 — PEER-REVIEWED PUBLICATIONS - 10+ — GRANTED PATENTS ### On this page - 01 — Clinical Studies - 02 — Real-World Evidence - 03 — Consumer Studies - 04 — Preclinical Research *UNDERSTANDING THE EVIDENCE* ### Not all evidence is the same. Different types of research answer different questions. The SiPore® evidence program spans controlled clinical studies, real-world evidence, consumer research and preclinical science. Each contributes a different part of the picture. > **We keep these evidence types distinct, because each supports a different level of conclusion.** - **CLINICAL STUDIES** — What happens under controlled human study conditions? — Studies conducted according to defined clinical protocols, including randomized and placebo-controlled research. - **REAL-WORLD EVIDENCE** — What is observed outside a traditional controlled trial? — Research examining outcomes and experience under real-world conditions. - **CONSUMER STUDIES** — What do users report experiencing? — Structured surveys capturing self-reported experiences with SiPore®-powered products. - **PRECLINICAL RESEARCH** — How does the technology work? — Laboratory and animal research used to investigate mechanism, digestion and the engineered properties of SiPore®. *CLINICAL STUDIES* ### Six clinical trials. A growing body of human evidence. The SiPore® clinical program has progressed from early safety and mechanism studies into controlled studies exploring post-meal glucose, longer-term metabolic outcomes and glucose stability. SHINE is the largest SiPore® clinical trial conducted to date. The study evaluated engineered mesoporous silica particles in individuals with prediabetes or type 2 diabetes and was published in eClinicalMedicine in 2026. The trial reported findings across multiple metabolic markers, including body weight, fat mass and lipids, while SiPore® was generally well tolerated in the studied population. #### SHINE - PROOF-OF-CONCEPT CLINICAL TRIAL — STAR — N = 43 • Prediabetes / newly diagnosed, drug-naive type 2 diabetes - PLACEBO-CONTROLLED CROSSOVER STUDY — Postprandial — N = 20 • Healthy adults • Single-dose crossover - FIRST HUMAN EVALUATION — First-in-Man — N = 20 • Male participants - CONTINUOUS GLUCOSE MONITORING — CGM Study 1 — Lower-dose SiPore® regimen • Placebo-controlled CGM research - CONTINUOUS GLUCOSE MONITORING — CGM Study 2 — N = 29 • Higher-dose SiPore® regimen [Read the paper →](https://sipore.com/docs/shine-trial) *THE CLINICAL PROGRAM* ### From safety and mechanism to broader metabolic evaluation. Across the clinical research program, SiPore® has been investigated in areas including: Different studies, doses and populations answer different questions. Findings should therefore always be understood in the context of the specific study in which they were generated. - Post-meal glucose response - Longer-term glycaemic markers - Body weight and body composition - Blood lipids - Glucose variability - Safety and tolerability [View peer-reviewed publications →](https://sipore.com/science/publications) *REAL-WORLD EVIDENCE* ### Beyond the controlled clinical setting. Clinical trials tell us what happens under controlled research conditions. Real-world evidence adds another perspective: what is observed when an intervention is used under everyday conditions. The study evaluated appetite, weight and tolerability in adults using a SiPore®-powered intervention. It explored hunger, urge to snack, sugar cravings, post-meal fatigue, weight, tolerability, adherence and user satisfaction. The study observed changes across several appetite-related measures and weight outcomes, alongside high adherence and generally good tolerability. #### U.S. Real-World Evidence Study [Read the study →](https://sipore.com/science/us-real-world-evidence-study) *CONSUMER STUDIES* ### What people report experiencing. Consumer research provides a different kind of evidence from clinical trials. It can help us understand how people describe their experience with SiPore®-powered products in everyday use, but these findings are self-reported and should not be interpreted as controlled clinical outcomes. - CONSUMER SURVEY — Real-World Insights on Weight, Appetite and Blood Sugar Control — N = 46 • 2025 - CONSUMER SURVEY — Self-Reported Benefits on Appetite, Energy and Metabolic Well-being — Survey cohort: N = 152 • 2024 *PRECLINICAL RESEARCH* ### Understanding how the technology works. Preclinical science is the foundation for understanding the SiPore® mechanism. The current evidence overview identifies five key peer-reviewed preclinical publications spanning 2014–2023. - PRECLINICAL RESEARCH — Activity and Stability of Nanoconfined Alpha-Amylase in Mesoporous Silica — Iqbal et al., 2023 • ACS Materials Au - PRECLINICAL / TRANSLATIONAL RESEARCH — Mesoporous Silica Particles Retain Their Structure and Function while Passing through the Gastrointestinal Tracts of Mice and Humans — Iqbal et al., 2023 • ACS Applied Materials & Interfaces - PRECLINICAL RESEARCH — Towards Mesoporous Silica as a Pharmaceutical Treatment for Obesity – Impact on Lipid Digestion and Absorption — May et al., 2022 • European Journal of Pharmaceutics and Biopharmaceutics - ANIMAL RESEARCH — Mesoporous Silica with Precisely Controlled Pores Reduces Food Efficiency and Suppresses Weight Gain in Mice — Rinde et al., 2020 • Nanomedicine - ANIMAL RESEARCH — Large Pore Mesoporous Silica Induced Weight Loss in Obese Mice — Kupferschmidt et al., 2014 • Nanomedicine *THE RESEARCH CONTINUUM* ### Each layer adds to the picture. Preclinical research helps explain how the engineered material behaves and how the mechanism works. Clinical studies test defined questions under controlled human research conditions. Real-world evidence extends observation into everyday use. Consumer research captures the experiences people themselves report. > **No single evidence type answers every question. Together, they form the SiPore® research program.** - ENGINEERED MATERIAL - MECHANISM - CONTROLLED HUMAN STUDIES - REAL-WORLD EVIDENCE - CONSUMER EXPERIENCE *OUR APPROACH TO EVIDENCE* ### Study type matters. - CLINICAL STUDY — Human research conducted under a defined clinical protocol. - REAL-WORLD EVIDENCE — Observational evidence generated in real-world use. - CONSUMER STUDY — Self-reported consumer experience. - PRECLINICAL RESEARCH — Laboratory or animal evidence used to investigate mechanism and biological effects. *SAFETY & TOLERABILITY* ### Evaluated across the research program. Safety and tolerability have been evaluated through dedicated human research as well as across the broader SiPore® clinical program. Across the human evidence base, SiPore® has been generally well tolerated. [Explore Safety & Tolerability →](https://sipore.com/science/safety-tolerability) *9 PEER-REVIEWED PUBLICATIONS* ### Go directly to the science. Explore the peer-reviewed literature behind SiPore®, including human clinical studies, mechanism research, safety research and preclinical publications. [View all publications →](https://sipore.com/science/publications) ### Continue exploring the evidence. - **SAFETY & TOLERABILITY** — How has SiPore® been tolerated? — Explore gut-local action, human safety research and tolerability across the clinical program. - **PUBLICATIONS** — Where can I read the papers? — Browse the peer-reviewed SiPore® research library and link directly to scientific publications. - **SCIENTIFIC FAQ** — Can I get a clear answer? — Clear answers to common questions about SiPore® science, evidence, mechanism and study types. - **TECHNOLOGY** — How does SiPore® work? — Return to the mechanism story: engineered pores, digestive-enzyme entrapment and more gradual digestion. ## How to cite SiPore Technologies (Sigrid Therapeutics AB). “Research & Evidence”. SiPore, 2026-10-02. https://sipore.com/science/research-evidence (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/research-evidence) · [Site index for agents (llms.txt)](https://sipore.com/llms.txt)