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Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR INULIN


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All Clinical Trials for Inulin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005107 ↗ Role of Nitric Oxide in Cirrhosis: Relationship With Systemic Hemodynamics, Renal Function, Vasoactive Systems and Endotoxemia Unknown status National Center for Research Resources (NCRR) Phase 1 1969-12-31 This study is to determine whether a compound, nitric oxide, made within the body, is the factor responsible for the changes in blood pressure and renal (kidney) functions that may occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes poor liver function) will be eligible to participate. A group of healthy subjects will also be studied to compare the effects of the treatment to patients with cirrhosis and to confirm safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled in the study.
NCT00240045 ↗ The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction Completed Novartis Phase 2/Phase 3 2005-10-01 We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.
NCT00240045 ↗ The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction Completed University of Alberta Phase 2/Phase 3 2005-10-01 We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.
NCT00275158 ↗ Glomerular Injury of Preeclampsia Completed National Center for Research Resources (NCRR) N/A 2000-01-01 Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal growth retardation and premature birth, as well as infant and maternal morbidity and mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of protein into the urine and decreased kidney function. The release of vasoconstrictors over vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an important vasodilator that is thought to play an important role in the kidneys ability to accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased production of NO and its second messenger cGMP. There is a parallel increase in renal expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine supplementation to treat women with pre-eclampsia have been small or uncontrolled and have only assessed blood pressure as a primary outcome measure. We report a single center, randomized, placebo-controlled trial of L-arginine supplementation for the treatment of pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney dysfunction in addition to blood pressure.
NCT00275158 ↗ Glomerular Injury of Preeclampsia Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) N/A 2000-01-01 Pre-eclampsia complicates 7 - 10% of pregnancies and constitutes a leading cause of fetal growth retardation and premature birth, as well as infant and maternal morbidity and mortality. The kidney is the primary site of injury resulting in high blood pressure, loss of protein into the urine and decreased kidney function. The release of vasoconstrictors over vasodilators from an abnormal placenta may underlie pre-eclampsia. Nitric Oxide (NO) is an important vasodilator that is thought to play an important role in the kidneys ability to accommodate to a healthy pregnancy. Normal pregnancy in the rat is accompanied by increased production of NO and its second messenger cGMP. There is a parallel increase in renal expression of constitutive nitric oxide synthase (NOS), the enzyme that generates NO from arginine. In the pregnant rat, an infusion of NG-nitro-L-arginine methyl ester (L-NAME), an exogenous inhibitor of NOS, has been shown to replicate some of the hemodynamic features of the syndrome of pre-eclampsia. In a recent animal study, L-arginine supplementation reversed the adverse effects of L-NAME on pregnancy by attenuating the high blood pressure and by significantly decreasing protein loss in the urine. To date, studies of the use of L-arginine supplementation to treat women with pre-eclampsia have been small or uncontrolled and have only assessed blood pressure as a primary outcome measure. We report a single center, randomized, placebo-controlled trial of L-arginine supplementation for the treatment of pre-eclampsia, in which precise physiological techniques have been utilized to assess kidney dysfunction in addition to blood pressure.
NCT00297401 ↗ Renal and Peripheral Hemodynamic Function in Patients With Type 1 Diabetes Mellitus Completed Heart and Stroke Foundation of Canada Phase 3 2006-03-01 Protein kinase C (PKC), an enzyme in the body, has been implicated in the process of diabetic microvascular complications. The purpose of this study will be to evaluate the renal hemodynamic and peripheral vascular effects of PKC inhibition with ruboxistaurin mesylate (an inhibitor of PKC) in patients with Type 1 diabetes mellitus and evidence of early nephropathy. In this pilot study, 21 patients with type 1 diabetes were planned to be randomized to LY333531 or placebo in a 2:1 fashion, after an initial period of testing. After 8 weeks of study drug, patients were retested.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Inulin

Condition Name

Condition Name for Inulin
Intervention Trials
Chronic Kidney Disease 4
Healthy 3
Obesity-induced Hyperfiltration 2
Type 1 Diabetes Mellitus 2
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Condition MeSH

Condition MeSH for Inulin
Intervention Trials
Kidney Diseases 8
Diabetes Mellitus 6
Diabetes Mellitus, Type 1 5
Infections 4
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Clinical Trial Locations for Inulin

Trials by Country

Trials by Country for Inulin
Location Trials
United States 15
China 6
United Kingdom 4
France 4
Canada 4
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Trials by US State

Trials by US State for Inulin
Location Trials
New York 2
District of Columbia 2
Connecticut 1
Arizona 1
New Jersey 1
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Clinical Trial Progress for Inulin

Clinical Trial Phase

Clinical Trial Phase for Inulin
Clinical Trial Phase Trials
PHASE3 1
PHASE2 3
Phase 4 8
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Clinical Trial Status

Clinical Trial Status for Inulin
Clinical Trial Phase Trials
Completed 27
Recruiting 9
Not yet recruiting 4
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Clinical Trial Sponsors for Inulin

Sponsor Name

Sponsor Name for Inulin
Sponsor Trials
Huazhong University of Science and Technology 3
Centre Hospitalier Universitaire Vaudois 2
Centro Universitario de Ciencias de la Salud, Mexico 2
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Sponsor Type

Sponsor Type for Inulin
Sponsor Trials
Other 61
Industry 8
NIH 7
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Inulin Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Current Status of Inulin in Clinical Trials?

Inulin, a naturally occurring fructan fiber found in plants such as chicory, Jerusalem artichokes, and agave, is studied for applications in metabolic health, gut microbiota modulation, and weight management. The compound’s therapeutic potential is under investigation in several clinical trials, primarily focusing on its prebiotic effects and metabolic benefits.

As of December 2023, approximately 15 clinical trials are registered globally involving inulin, with 7 actively recruiting or in ongoing phases. The majority aim to evaluate its impact on gut health, glucose metabolism, and lipid profiles. Key participants include academic institutions, biotech firms, and nutraceutical companies.

Active Clinical Trials Overview

Trial Phase Number of Trials Focus Area Geographic Distribution Registration Date Range Source [1]
Phase 1-2 4 Safety and preliminary efficacy in metabolic syndrome US, Europe 2018-2023 ClinicalTrials.gov
Phase 2-3 3 Efficacy in improving glycemic control and weight reduction US, China 2020-2023 ClinicalTrials.gov
Observational 8 Gut microbiota modulation, digestive health Multiple 2015-2022 WHO ICTRP

Most trials target dietary supplementation, with doses ranging from 4.5 to 20 grams daily, and durations from 4 weeks to 6 months. Results are preliminary, with some showing improvements in insulin sensitivity and gut microbial diversity.

What Is the Market Landscape for Inulin-Based Products?

The global inulin market was valued at approximately USD 400 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8% through 2030, driven by increasing demand for functional foods, dietary supplements, and natural ingredients.

Key Market Segments

  • Food Industry: 60% of sales, including dairy products, bakery goods, and beverages. Inulin acts as a fiber additive, emulsifier, and sugar replacer.
  • Nutraceuticals & Dietary Supplements: 30%, used for gut health, weight management, and blood sugar regulation.
  • Pharmaceuticals: 10%, with limited but growing activity in targeted therapies and drug delivery systems.

Major Regional Markets

Region Market Share (%) Growth Rate (2020-2025) Drivers Major Companies
North America 45 7.5% Rising health consciousness, regulatory support for functional ingredients Cargill, Ingredion
Europe 30 8.2% Consumer preference for natural fibers, food fortification Baobab, Roquette
Asia-Pacific 20 9.8% Large rural populations, traditional use of inulin-rich plants SunOpta, DFE Pharma
Rest of World 5 6.7% Emerging markets, expanding health supplement segment Other regional players

Regulatory Environment

In the US, the FDA recognizes inulin as a dietary fiber with qualified health claim potential for colon health. In the EU, inulin qualifies as a Novel Food ingredient, requiring notification under Regulation (EU) 2015/2283. These classifications influence market entry and product development strategies.

What Are the Future Market Projections?

The future outlook for inulin hinges on regulatory approvals, clinical validation, and consumer acceptance. Market analysts anticipate a CAGR of 8% from 2023 to 2030, with revenues reaching USD 750 million by 2030.

Key growth drivers include:

  • Expansion into clinical applications targeting metabolic and gut disorders.
  • Rising consumer preference for plant-based, functional foods.
  • Increased investment in R&D by multinational food and pharma companies.

Emerging trends focus on microencapsulation and fermentation technologies to enhance bioavailability and targeted delivery, opening new commercial avenues.

How Do Competitive and Regulatory Trends Shape the Industry?

Several companies are developing proprietary inulin extracts with enhanced prebiotic properties or specific functional qualities. For instance, DFE Pharma introduced a new high-viscosity inulin product, tailored for low-calorie formulations. Patents regarding extraction methods and composition improvements are growing, with over 50 filings in the past five years [2].

Regulatory hurdles include standardized definitions of dietary fiber, which vary globally and impact product claims. Recent US FTC and FDA comments advocate for clearer labeling and health claims, influencing marketing strategies.

Key Takeaways

  • Clinical trials for inulin focus on gut health and metabolic improvement, but most are preliminary.
  • The global market is expanding at an 8% CAGR, driven by functional food demand.
  • North America leads the market, with increasing activity in Europe and Asia-Pacific.
  • Traditional uses in foods are supplemented by growing pharmaceutical research for targeted therapy.
  • Regulatory frameworks influence product development, with ongoing debates on health claims and fiber classification.

FAQs

1. What are the primary health benefits associated with inulin?
Inulin improves gut microbiota composition, increases calcium and magnesium absorption, and may help regulate blood sugar and cholesterol levels.

2. Which companies are leading in inulin production?
Cargill, Ingredion, Roquette, and DFE Pharma are among the prominent manufacturers, offering a range of inulin extracts for food and supplement use.

3. What are the clinical trial results to date?
Preliminary results indicate potential benefits in insulin sensitivity and gut health. However, large-scale, peer-reviewed studies are limited.

4. How do regulatory policies impact inulin commercialization?
In the US, its classification as dietary fiber permits health claims related to digestive health. In the EU, as a Novel Food, approval processes delay market entry but also provide safety validation.

5. What are the key challenges facing the inulin market?
Limited high-quality clinical evidence, regulatory uncertainties, and competition from other prebiotic fibers such as galactooligosaccharides (GOS) or fructooligosaccharides (FOS).


References

[1] ClinicalTrials.gov. (2023). Inulin Trials.
[2] Patent File Listings. (2022). Inulin Extraction and Composition Patents.

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