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Last Updated: February 15, 2025

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
Metabolic Syndrome 2
Diabetes Mellitus, Type 1 2
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Condition MeSH

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

Trials by Country

Trials by Country for Inulin
Location Trials
United States 13
Canada 4
United Kingdom 4
France 3
Switzerland 3
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Inulin
Clinical Trial Phase Trials
Phase 4 8
Phase 3 5
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Inulin
Clinical Trial Phase Trials
Completed 26
Recruiting 6
Unknown status 4
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Clinical Trial Sponsors for Inulin

Sponsor Name

Sponsor Name for Inulin
Sponsor Trials
University of Edinburgh 2
National Center for Research Resources (NCRR) 2
Rabin Medical Center 2
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Sponsor Type

Sponsor Type for Inulin
Sponsor Trials
Other 52
Industry 6
NIH 5
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Inulin: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Inulin

Inulin, a naturally occurring prebiotic fiber, has garnered significant attention in recent years for its multifaceted health benefits and potential therapeutic applications. Derived from chicory root, inulin is known for its prebiotic properties, which support gut health, improve digestion, and offer various other health advantages.

Clinical Trials and Therapeutic Applications

Inulin in Cancer Therapy

Inulin has been explored for its potential in cancer therapy due to its unique structure, stability, and nutritional properties. It is being developed as an adjuvant and carrier for drug delivery in cancer treatment, aiming to mitigate the adverse effects associated with traditional chemotherapeutic agents. Ongoing clinical trials and observational studies are investigating the role of inulin-based nanomaterials and nanocomposites in cancer therapy, highlighting its synergistic, signaling, immunomodulatory, and anticarcinogenic properties[1].

Gastrointestinal Health and Fructanase Administration

A recent clinical trial focuses on the effects of oral fructanase administration on gastrointestinal symptoms after inulin consumption in healthy adults. This study aims to evaluate whether fructanase, an enzyme that hydrolyzes dietary fructans, can reduce GI symptoms and lower breath biomarkers of intestinal microbial fermentation. The trial involves administering fructanase or a placebo with oatmeal and 25 grams of inulin to participants, monitoring their GI symptoms and breath hydrogen and methane levels over several hours[4].

Market Analysis and Projections

Global Market Size and Growth

The global inulin market has shown robust growth in recent years. As of 2023, the market size was valued at approximately USD 1.8 billion and is expected to expand at a Compound Annual Growth Rate (CAGR) of 6.2% from 2024 to 2032. This growth is driven by the increasing demand for functional foods, dietary supplements, and natural ingredients, particularly in health-conscious consumer markets[2].

Regional Market Dominance

The United States holds a prominent position in the global inulin market, with a market size of around USD 608.2 million in 2023. The U.S. market is driven by extensive research, a proactive approach to health and wellness, and a thriving market for functional ingredients. This region is expected to continue influencing the global market landscape significantly[2].

Industry Drivers and Trends

Several factors are driving the growth of the inulin market:

  • Health Benefits: Inulin's purported health benefits, including better digestion, improved gut health, and potential management of metabolic disorders, are key drivers.
  • Food and Beverage Industry: The use of inulin as a natural sugar and fat substitute, along with its texture-enhancing qualities, makes it a valuable ingredient in various food and beverage products[2][5].
  • Consumer Awareness: Growing consumer awareness of the connection between nutrition and health has increased demand for functional foods and ingredients like inulin[5].

Market Projections

By 2033, the global inulin market is projected to reach a valuation of USD 2,345 million, growing at a CAGR of 3.4% from 2023. The expansion of the dairy industry, rising diabetes prevalence, and the growing awareness of low-calorie and sugar-free alternatives are expected to further drive this growth[5].

Challenges and Regulatory Considerations

Despite the positive outlook, the inulin market faces several challenges:

  • Compliance Complexities: Changing regulations and compliance complexities can impact product development, market entry, and operational procedures, requiring constant adaptation and adherence to evolving standards[2].
  • Regulatory Hurdles: These regulatory challenges can potentially impede seamless market integration and innovation within the industry[2].

Consumer and Market Trends

E-commerce Impact

The proliferation of e-commerce websites has increased the sales of inulin and functional food items containing inulin over the last decade. Although the market experienced a setback during the COVID-19 pandemic, the increased importance of food supplements during this period is expected to have a long-term positive impact on inulin demand[5].

Health and Wellness

The growing trend towards better lifestyles and increased awareness of the importance of nutrition in health has significantly boosted the demand for inulin. Consumers are increasingly seeking natural prebiotic ingredients and functional foods, positioning inulin as a key player in the health and wellness market[2][5].

Key Takeaways

  • Clinical Trials: Inulin is being explored for its therapeutic potential in cancer treatment and gastrointestinal health, with ongoing clinical trials evaluating its efficacy.
  • Market Growth: The global inulin market is expected to grow significantly, driven by increasing demand for functional foods and dietary supplements.
  • Regional Dominance: The United States is a leading market for inulin, driven by consumer awareness and a robust health and wellness industry.
  • Challenges: Regulatory complexities and compliance issues pose challenges to market growth and innovation.
  • Consumer Trends: Growing consumer awareness of health benefits and the rise of e-commerce are driving the demand for inulin.

FAQs

What are the primary health benefits of inulin?

Inulin is known for its prebiotic properties, which support gut health, improve digestion, and potentially manage metabolic disorders.

How is inulin used in the food and beverage industry?

Inulin is used as a natural sugar and fat substitute and for its texture-enhancing qualities in various food and beverage products.

What are the projected market values for inulin by 2033?

The global inulin market is projected to reach a valuation of USD 2,345 million by 2033, growing at a CAGR of 3.4% from 2023.

What challenges does the inulin market face?

The inulin market faces challenges related to compliance complexities and changing regulations, which can impact product development and market integration.

How has the COVID-19 pandemic affected the inulin market?

The pandemic increased the importance of food supplements, including inulin, which is expected to have a long-term positive impact on its demand despite initial market setbacks.

Sources

  1. Inulin-based formulations as an emerging therapeutic strategy for ... - PubMed
  2. Inulin Market Size & Share, Global Analysis 2024-2032 - Global Market Insights
  3. Inulin Market Research Report - Global Forecast to 2024 - SpendEdge - Business Wire
  4. The Effects of Oral Fructanase Administration on Gastrointestinal ... - CenterWatch
  5. Inulin Market Demand, Trends & Forecast to 2033 | FMI - Future Market Insights

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