OPTIZIOME® Fructanase - Clinical Research Data Summary
OPTIZIOME® Fructanase (Inulinase Enzyme)
OPTIZIOME® Fructanase is a clinically studied ingredient used in the following Silver Fern™ Brand product:
- Digestive Enzymes (Broad Spectrum) – https://www.silverfernbrand.com/products/digestive-enzyme
Introduction
OPTIZIOME® Fructanase (inulinase enzyme) is a clinically studied, food-grade enzyme designed to break down fructan-type FODMAPs — a class of fermentable carbohydrates commonly found in foods such as garlic, onions, wheat, leeks, and asparagus. Derived from wild-type, non-genetically engineered Aspergillus tubingensis, OPTIZIOME® Fructanase works during gastric digestion to hydrolyze fructans before they reach the colon, where they are typically fermented by gut bacteria.
Unlike dietary elimination strategies that restrict entire food categories and may limit intake of beneficial fibers, OPTIZIOME® Fructanase is intended to be used alongside a normal diet. When taken with meals, it helps break down fructans in food, reducing the amount that reaches the lower digestive tract. This positions it alongside other well-established digestive enzymes such as lactase (for lactose digestion) and alpha-galactosidase (for the breakdown of certain oligosaccharides), helping to address a broader range of carbohydrate digestion.*
OPTIZIOME® Fructanase is supported by preclinical in vitro research and a randomized, double-blind, placebo-controlled human study. Laboratory data demonstrate effective fructan breakdown across a range of dietary substrates at relevant use levels. The human study supports its safety and tolerability under the conditions tested.*
There are currently two published studies for OPTIZIOME® Fructanase. Below, we provided a summary of each key data for each study, along with a link to the complete clinical research.
- Summary of Study 1 – Full Study: https://pubmed.ncbi.nlm.nih.gov/39318719/
- Summary of Study 2 – Full Study: https://doi.org/10.3389/fnut.2023.1129329
Ingredient Manufacturer Website: https://www.bio-cat.com/optiziome-fructanase/
Study 1 Summary
Complete Study Information: https://pubmed.ncbi.nlm.nih.gov/39318719/
Safety and Tolerability of OPTIZIOME® Inulinase in Healthy Adults
Garvey, S.M. et al. Gastro Hep Advances. 2024; 3: 920–930.
This randomized, double-blind, placebo-controlled clinical trial evaluated the safety and tolerability of OPTIZIOME® Inulinase in 60 healthy adults (ages 20–60) over 4 weeks (preceded by a 2-week placebo run-in). The objective was to assess safety and tolerability under controlled conditions prior to further investigation in broader populations.
Study Design Highlights
- Study design: Randomized, double-blind, placebo-controlled clinical trial
- Participants: 60 healthy adults (ages 20–60)
- Duration: 4 weeks (preceded by 2-week placebo run-in)
- Groups: 2,000 INU/day OPTIZIOME® Inulinase (1,000 INU per capsule, twice daily with meals) vs. placebo (tapioca maltodextrin capsules)
- Primary outcomes: Blood clinical chemistry and hematology, lipid profile, hs-CRP, insulin, lactate, uric acid, adverse event monitoring, gastrointestinal tolerability (GSRS, assessed weekly)
Key Findings (What the Study Showed)
1. No Clinically Meaningful Changes in Safety Biomarkers
After 4 weeks, no clinically meaningful changes were observed across 37 blood parameters, including liver enzymes (ALT, AST, alkaline phosphatase), kidney function markers (creatinine, eGFR, urea), lipid panel (total cholesterol, LDL, HDL, triglycerides), inflammatory marker (hs-CRP), insulin and blood glucose, lactate, and uric acid. All values remained within normal clinical ranges throughout the study.
2. Favorable Tolerability Profile
Adverse events reported in both groups were generally mild. No serious adverse events or discontinuations related to the study product were observed.
3. Gastrointestinal Tolerability Consistent with Healthy Population
No significant differences were observed between groups in gastrointestinal tolerability scores as measured by the Gastrointestinal Symptom Rating Scale (GSRS). Scores remained low and stable throughout the study period.
Benefits of OPTIZIOME® Fructanase Demonstrated by This Study
Based directly on the clinical outcomes, OPTIZIOME® Inulinase was shown to:
✓ Be well-tolerated in healthy adults under the conditions studied
✓ Maintain stable clinical chemistry and hematology markers across 37 blood parameters
✓ Demonstrate a favorable safety profile over 4 weeks of twice-daily mealtime use
✓ Support gastrointestinal tolerability at intake levels consistent with mealtime use
✓ Produce no serious adverse events or study-related discontinuations
Why This Study Matters
Establishing safety and tolerability is an important first step in the evaluation of any enzyme ingredient intended for regular use. This study demonstrates that OPTIZIOME® Inulinase can be consumed at practical intake levels without adverse effects on key metabolic or clinical markers, providing a foundation for continued research evaluating its functional applications.*
Reference Link: https://pubmed.ncbi.nlm.nih.gov/39318719/
Study 2 Summary
Complete Study Information: https://doi.org/10.3389/fnut.2023.1129329
In Vitro Fructan Hydrolysis by OPTIZIOME® Inulinase Under Simulated Gastric Conditions
Guice, J.L. et al. Frontiers in Nutrition. 2023; 10: 1129329.
This preclinical in vitro study evaluated whether OPTIZIOME® Inulinase can effectively break down fructan-type carbohydrates under conditions designed to simulate human gastric digestion. Using the internationally validated INFOGEST static digestion model, researchers assessed enzyme activity across a range of doses (3.125–800 INU per serving) and substrates including purified inulin, minced garlic, and complex mixed meal matrices.
Study Design Highlights
- Study type: In vitro digestion simulation (INFOGEST static model)
- Enzyme tested: OPTIZIOME® Inulinase from wild-type Aspergillus tubingensis
- Dose range: 3.125 to 800 INU per serving
- Substrates: Purified inulin (chicory-derived), minced garlic, inulin-spiked canned test meal, garlic-spiked canned test meal, mixed high-fructan test meal (black bean patty, Brussels sprouts, onions, garlic)
- Analytical methods: HPLC (fructose quantitation) and LC-MS (fructan chain-length profiling)
Key Findings (What the Study Showed)
1. Active Across Gastric pH Conditions
Inulinase demonstrated consistent enzymatic activity across the acidic pH range representative of the human stomach, with peak activity around pH 5 and measurable activity down to pH 2. The presence of digestive enzymes such as salivary amylase and gastric pepsin did not interfere with inulinase activity.
2. Effective Fructan Hydrolysis Across Multiple Food Sources
Inulinase increased the release of fructose — a marker of fructan breakdown — compared to enzyme-free controls across all substrates tested, including purified inulin, garlic, and mixed meals. Enzymatic activity was observed across the full dose range evaluated.
3. Reduction of Higher Molecular Weight Fructans at Relevant Doses
LC-MS analysis confirmed that inulinase reduced higher-degree polymerized fructans under simulated digestion conditions. At higher doses, substantial hydrolysis of longer-chain fructans was observed across multiple substrates.
4. Primary Activity During Gastric Phase
Comparative digestion modeling showed that the majority of fructan hydrolysis occurred during the gastric phase, with limited additional breakdown during the intestinal phase, indicating that enzymatic activity occurs early in the digestive process.
5. Maintains Activity in Complex Food Matrices
Inulinase remained active in mixed meal conditions containing multiple food components, demonstrating functionality within realistic dietary contexts.
Benefits of OPTIZIOME® Fructanase Demonstrated by This Study
Based directly on the in vitro findings, OPTIZIOME® Inulinase was shown to:
✓ Break down fructan-type carbohydrates under simulated gastric conditions
✓ Remain active in the presence of endogenous digestive enzymes (amylase, pepsin)
✓ Demonstrate activity across purified substrates and complex food matrices
✓ Reduce higher molecular weight fructans at intake levels relevant to supplementation
✓ Act primarily during the gastric phase of digestion — before fructans reach the colon
✓ Exhibit dose-responsive enzymatic activity across a wide range
✓ Maintain functionality in diverse food matrices including garlic, onions, and mixed meals
Why This Study Matters
This study provides mechanistic evidence that OPTIZIOME® Inulinase is active under conditions designed to reflect human digestion and across a range of commonly consumed foods. The findings demonstrate that fructan hydrolysis can occur early in the digestive process and across realistic meal compositions, supporting its role as a digestive enzyme intended to assist in the breakdown of fructan-containing foods when consumed as part of a normal diet.*
Reference Link: https://doi.org/10.3389/fnut.2023.1129329
Big-Picture Integration with Other Studies
- Study 1: Demonstrated safety and tolerability in healthy adults, with no clinically meaningful changes in blood chemistry, hematology, or gastrointestinal tolerability measures over 4 weeks of twice-daily mealtime use.
- Study 2: Provided mechanistic evidence of fructan hydrolysis across a range of dietary substrates — including garlic, onions, inulin, and mixed meals — under simulated gastric conditions, at intake levels relevant to supplementation.
Together, these findings support OPTIZIOME® Fructanase as a targeted digestive enzyme with both mechanistic characterization and clinical safety data, designed for supporting the digestion of fructan-containing foods as part of a normal diet.*
OPTIZIOME® Fructanase Ingredient Summary & Real-World Relevance
Many commonly consumed foods — including garlic, onions, wheat, and certain vegetables — contain fructan-type carbohydrates that can be difficult to digest. Traditional approaches often involve reducing or avoiding these foods, which may also limit dietary variety and fiber intake.
OPTIZIOME® Fructanase offers an alternative approach by supporting the breakdown of fructans during digestion.* Derived from wild-type, non-genetically engineered Aspergillus tubingensis, it is designed to work in the stomach to hydrolyze fructan-type carbohydrates before they reach the lower digestive tract.*
Preclinical research using the internationally validated INFOGEST digestion model demonstrated the ability to hydrolyze fructans across purified substrates and complex meals — including garlic, inulin, and mixed food matrices — at intake levels relevant to supplementation. A randomized, placebo-controlled human study further demonstrated that 4 weeks of use was well-tolerated and did not produce clinically meaningful changes in measured safety markers.*
The result is an ingredient with a defined mechanism of action and a favorable safety profile, supporting its use as part of digestive enzyme formulations designed to assist in the breakdown of fructan-containing foods as part of a normal diet.*
Ingredient Manufacturer Website: https://www.bio-cat.com/optiziome-fructanase/
OPTIZIOME® Fructanase is a clinically studied ingredient used in the following Silver Fern™ Brand product:
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.