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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR BETAINE HYDROCHLORIDE


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All Clinical Trials for Betaine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00152815 ↗ Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions Terminated Ontario HIV Treatment Network Phase 2 2003-10-01 The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
NCT00152815 ↗ Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions Terminated Johane Allard Phase 2 2003-10-01 The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.
NCT00226356 ↗ Natural Supplements for Unipolar Depression Completed National Alliance for Research on Schizophrenia and Depression Phase 4 2004-12-01 This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.
NCT00226356 ↗ Natural Supplements for Unipolar Depression Completed Cambridge Health Alliance Phase 4 2004-12-01 This study is being conducted to determine the clinical response rate for the regimen of L-methionine, betaine and folate for unipolar depression.
NCT00283387 ↗ Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2007-02-01 The aim of this study is to assess the efficacy and safety of betaine in reducing urine oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients. Hypothesis: Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I patients.
NCT00283387 ↗ Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria Completed Orphan Europe Phase 2 2007-02-01 The aim of this study is to assess the efficacy and safety of betaine in reducing urine oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients. Hypothesis: Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I patients.
NCT00283387 ↗ Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria Completed Mayo Clinic Phase 2 2007-02-01 The aim of this study is to assess the efficacy and safety of betaine in reducing urine oxalate excretion of Type 1 Primary Hyperoxaluria (PHI) patients. Hypothesis: Betaine will effectively reduce urine oxalate excretion in Primary Hyperoxaluria Type I patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Betaine Hydrochloride

Condition Name

Condition Name for Betaine Hydrochloride
Intervention Trials
Homocystinuria 3
Healthy 2
Chronic Hepatitis C 2
Men Carrying 2 Minor Alleles for Choline Dehydrogenase rs12676 1
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Condition MeSH

Condition MeSH for Betaine Hydrochloride
Intervention Trials
Homocystinuria 4
Hepatitis 3
Hepatitis, Chronic 3
Hepatitis C, Chronic 3
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Clinical Trial Locations for Betaine Hydrochloride

Trials by Country

Trials by Country for Betaine Hydrochloride
Location Trials
United States 19
Canada 4
Italy 2
Serbia 1
India 1
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Trials by US State

Trials by US State for Betaine Hydrochloride
Location Trials
California 4
Massachusetts 3
Nebraska 2
Minnesota 2
North Carolina 2
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Clinical Trial Progress for Betaine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Betaine Hydrochloride
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Betaine Hydrochloride
Clinical Trial Phase Trials
Completed 20
Terminated 2
Available 1
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Clinical Trial Sponsors for Betaine Hydrochloride

Sponsor Name

Sponsor Name for Betaine Hydrochloride
Sponsor Trials
University of California, San Francisco 3
McGill University Health Center 2
Mayo Clinic 2
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Sponsor Type

Sponsor Type for Betaine Hydrochloride
Sponsor Trials
Other 46
Industry 2
NIH 1
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Betaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Betaine Hydrochloride

Betaine hydrochloride (BHCl) is a form of betaine, a naturally occurring compound found in various foods and also produced synthetically. It is known for its diverse applications in human health, particularly in enhancing digestive health, improving nutrient absorption, and providing protective effects against physiological stresses.

Clinical Trials and Health Benefits

Enhancing Digestive Health

BHCl has been clinically studied for its role in reacidifying gastric pH, which is crucial for the proper digestion and absorption of nutrients. In individuals with hypochlorhydria (a condition characterized by low stomach acid), BHCl can help restore normal gastric pH levels, thereby improving the absorption of weakly basic drugs and nutrients[1].

Improving Drug Absorption

Clinical trials have shown that BHCl can enhance the absorption of certain drugs, such as dasatinib, a targeted anticancer drug. By reacidifying gastric pH, BHCl mitigates the reduced drug exposure caused by acid-reducing agents, thus enhancing the drug’s efficacy[1].

Addressing Insulin Resistance

Recent studies have explored the potential of betaine in reducing hepatic insulin resistance. In a study involving C57BL/6J mice, betaine supplementation was found to restore serum and liver betaine content, reduce whole-body insulin resistance, and improve insulin signaling in the liver. Similar results were observed in primary human hepatocytes treated with betaine, indicating its potential in preventing and treating insulin resistance[4].

Market Analysis

Market Size and Growth

The betaine market, which includes betaine hydrochloride, is projected to experience significant growth. As of 2024, the market size was over USD 3.8 billion and is anticipated to cross USD 7.2 billion by the end of 2037, with a compound annual growth rate (CAGR) of more than 4.9% during the forecast period[3].

Segment Analysis

The betaine hydrochloride segment is expected to increase its revenue share during the forecast period. This growth is driven by rising applications in dietary supplements aimed at boosting nutrient absorption and addressing issues of hypochlorhydria. The increasing awareness of gastrointestinal wellness among health-conscious consumers and the expanding geriatric population are key factors driving the demand for BHCl-based solutions[3].

Regional Market

North America dominates the betaine market, driven by high demand for personal care products, food, beverages, and dietary supplements. However, emerging opportunities in low- and middle-income countries in the Asia-Pacific and African regions are expected to create new revenue streams for key players in the sector[3].

Market Projections

Growth Drivers

  • Increasing Awareness of Health Benefits: The rising awareness globally about the health benefits of betaine, including its role in improving metabolism and enhancing athletic performance, is a significant driver of the market[3].
  • Expanding Geriatric Population: The growing geriatric population in both developed and emerging markets is leading to an increased prevalence of digestive disorders, creating a steady demand for BHCl-based solutions[3].
  • Sustainable Production Methods: The global consumer shift towards sustainable products is creating opportunities for manufacturers to explore bio-based and eco-friendly production methods, further boosting the market[3].

Challenges

  • Synthetic Cosmetics: The use of synthetic cosmetics, which can lead to skin and hair problems, may act as a restraint for the market[5].
  • COVID-19 Impact: Although the market has recovered from the detrimental effects of COVID-19, any future pandemics or global health crises could potentially impact market growth[5].

Applications Across Industries

Pharmaceutical Industry

BHCl is used in pharmaceutical applications to enhance the absorption of certain drugs. Its ability to reacidify gastric pH makes it an essential component in formulations where optimal drug absorption is critical[1].

Nutraceutical and Sports Nutrition

Betaine anhydrous, another form of betaine, is widely used in the nutraceutical and sports nutrition sectors due to its hydrating capabilities and its role in improving athletic performance. However, BHCl also finds its place in dietary supplements aimed at boosting nutrient absorption and addressing digestive issues[2].

Food and Beverage Industry

Betaine is used in the food and beverage industry as a surfactant and to enhance the nutritional profile of products. Its use in this sector is expected to grow as more businesses recognize its benefits[5].

Key Takeaways

  • Clinical Benefits: BHCl enhances digestive health, improves nutrient absorption, and aids in the absorption of certain drugs.
  • Market Growth: The betaine market, including BHCl, is projected to grow significantly, driven by increasing awareness of health benefits and expanding geriatric populations.
  • Regional Dominance: North America leads the market, but emerging regions offer new opportunities.
  • Sustainable Production: The shift towards sustainable production methods is expected to boost the market further.

FAQs

What is betaine hydrochloride used for in human health?

Betaine hydrochloride is used to enhance digestive health, improve nutrient absorption, and aid in the absorption of certain drugs by reacidifying gastric pH.

How does betaine hydrochloride improve drug absorption?

BHCl improves drug absorption by reacidifying gastric pH, which is essential for the optimal solubility and absorption of weakly basic drugs.

What are the key drivers of the betaine hydrochloride market?

The key drivers include increasing awareness of health benefits, expanding geriatric populations, and the global shift towards sustainable production methods.

Which region dominates the betaine market?

North America currently dominates the betaine market due to high demand for personal care products, food, beverages, and dietary supplements.

What are the potential challenges for the betaine hydrochloride market?

Challenges include the use of synthetic cosmetics leading to skin and hair problems and potential impacts from future global health crises.

Sources

  1. Consensus.app: "What Is Betaine Hydrochloride? Other Names: Acide Chlorhydrique de Betaine, Betaine HCL, Trimethylglycine Hydrochloride."
  2. Research Nester: "Betaine Market Analysis."
  3. Research Nester: "Betaine Market Size & Share | Growth Trends 2037."
  4. Frontiers in Nutrition: "Betaine for the prevention and treatment of insulin resistance and type 2 diabetes."
  5. Mordor Intelligence: "Betaine Market - Analysis, Size & Trends."

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