Curcumin for Brain Health Safety & Bioavailability Study

Overseen By Chwan-Li (Leslie) Shen, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Texas Tech University Health Sciences Center

Must not be taking: Antibiotics, Turmeric

Disqualifiers: Ocular diseases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance/composition of gut microbiota.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have taken turmeric or curcumin products within 2 weeks before starting the study.

What evidence supports the effectiveness of the treatment Curcumin for brain health?

Research suggests that curcumin, the active component in turmeric, has potential benefits for brain health due to its anti-inflammatory and antioxidant properties. It has shown neuroprotective effects in animal studies, such as reducing brain lesion size and improving neurological function after brain injury. ^{1 2 3 4 5}

Is curcumin generally safe for human use?

Curcumin is considered safe by the US FDA and has been used for thousands of years in traditional medicine. Safety studies on turmeric extracts like CURCUGEN® show no evidence of toxicity or genetic damage, even at high doses in animal studies. ^{2 6 7 8 9}

What makes curcumin unique as a treatment for brain health?

Curcumin, derived from turmeric, is unique for its potential neuroprotective effects, including anti-inflammatory and antioxidant properties, which may help in preventing or treating neurodegenerative diseases like Alzheimer's. Unlike many treatments, curcumin is a natural compound with a wide range of biological activities, but its bioavailability (how well it is absorbed and used by the body) is a challenge that researchers are working to improve. ^{5 8 10 11 12}

Research Team

Chwan-Li (Leslie) Shen, PhD

Principal Investigator

Texas Tech University Health Sciences Center

Eligibility Criteria

This trial is for people aged 40-89 with amyloid beta deposits in their retina, without liver or kidney diseases. It's not for pregnant/breastfeeding women, those with certain eye diseases, recent antibiotic use, or allergies to black pepper and turmeric.

Inclusion Criteria

I am between 40 and 89 years old.

Diagnosed with Aβ deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aβ deposits in retina within 6 months before the consent session, we will use this diagnosis/documentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study

I do not have any liver or kidney diseases.

Exclusion Criteria

I have not taken turmeric or curcumin in the last 2 weeks.

I am not pregnant or breastfeeding.

Had a known allergy to black pepper

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive curcumin supplementation to test its ability to cross the blood-brain barrier and bind to amyloid beta proteins

2 weeks

1 visit (baseline), 1 visit (after 2 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of retinal imaging and gut microbiome composition

4 weeks

Treatment Details

Interventions

• Curcumin

Trial Overview The study tests how two different doses of curcumin supplements affect the brain and gut over two weeks—whether they can cross into the brain and bind to specific proteins, as well as change gut bacteria.

Participant Groups

Group I: High curcumin group Active Control 1 Intervention

Group II: Low curcumin group Active Control 1 Intervention

Curcumin is already approved in United States, European Union, India, China for the following indications:

Approved in United States as Curcumin for:

• Dietary Supplement

Approved in European Union as Curcuma for:

• Herbal Medicinal Product

Approved in India as Haldi for:

• Traditional Medicine

Approved in China as Jiang Huang for:

• Traditional Chinese Medicine

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Findings from Research

Curcumin, the active component in turmeric, shows promise in treating various health issues, including inflammation, cancer, and neurodegenerative diseases, but faces challenges in clinical application due to low solubility and poor bioavailability.

Despite its potential benefits, excessive intake of curcumin can lead to adverse effects on organs such as the kidneys, heart, and liver, highlighting the need for caution and further research before widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on the Benefits and Problems of Curcumin with Respect to Human Health. Liu, S., Liu, J., He, L., et al.[2022]

In a study involving male Wistar rats, curcumin (100 mg/kg) significantly reduced brain injury lesions and improved neurological function after traumatic brain injury, indicating its potential neuroprotective effects.

Curcumin treatment also decreased oxidative stress levels in the brain, as shown by a reduction in malondialdehyde, suggesting that its antioxidant properties contribute to its protective efficacy in brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin pretreatment attenuates brain lesion size and improves neurological function following traumatic brain injury in the rat. Samini, F., Samarghandian, S., Borji, A., et al.[2013]

Curcumin, a compound derived from turmeric, has a wide range of beneficial effects, including antimicrobial, anti-inflammatory, antioxidant, and notably, antitumorigenic properties, making it a promising candidate for cancer treatment.

Research shows that curcumin can prevent tumor invasion and metastasis in various cancer models, and it has also shown potential to improve patient outcomes in clinical trials, highlighting its efficacy as an anti-invasive and antimetastatic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Farmer to pharmacist: curcumin as an anti-invasive and antimetastatic agent for the treatment of cancer. Bandyopadhyay, D.[2022]

Curcumin, the active compound in turmeric, has shown significant therapeutic properties, including anti-inflammatory, antioxidant, and cancer preventive effects, making it a promising treatment for chronic diseases like diabetes mellitus.

Despite its potential benefits, curcumin's low solubility in water limits its bioavailability, which poses challenges for its use as a therapeutic agent; ongoing research aims to improve its solubility and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CURCUMA LONGA AS MEDICINAL HERB IN THE TREATMENT OF DIABET- IC COMPLICATIONS. Karlowicz-Bodalska, K., Han, S., Freier, J., et al.[2018]

Curcumin, the active compound in turmeric, shows potential neuroprotective effects against neurodegenerative diseases like Alzheimer's disease due to its anti-inflammatory, antioxidant, and antiprotein-aggregate properties.

This review highlights recent evidence supporting curcumin's efficacy in protecting brain health, suggesting it could be a valuable addition to treatments for neurodegenerative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuroprotective effects of curcumin]. Li, Y., Wang, P.[2016]

Quercetin-decorated liposomes containing curcumin showed improved effectiveness in increasing the lifespan and body weight of mice with Dalton's ascites lymphoma compared to liposomes without quercetin, indicating enhanced therapeutic potential.

The study demonstrated that these liposomes, with a particle size of approximately 261.8 nm, not only improved the cytotoxicity against cancer cells (HT-29 and HCT-15) but also addressed curcumin's limitations like poor solubility and short biological half-life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. Ravichandiran, V., Masilamani, K., Senthilnathan, B., et al.[2018]

Curcumin, the main active compound in turmeric, has demonstrated a wide range of beneficial effects, including anti-inflammatory, antioxidant, and anti-cancer properties, making it a promising treatment for various diseases.

The review highlights that curcumin has an excellent safety profile, suggesting it can be used effectively in managing conditions like arthritis, Alzheimer's, and other chronic diseases without significant risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on Physiological Effects of Curcumin. Ahsan, R., Arshad, M., Khushtar, M., et al.[2021]

A novel bioactive fraction (NCCL) derived from a standardized extract of turmeric (Curcuma longa) demonstrated significant anti-cancer activity against various cancer cell lines, outperforming a newly isolated compound (compound I).

The study suggests that the NCCL fraction, which retains residual components from the original extract, may be more effective as a therapeutic drug for cancer treatment than the isolated compound alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Silico and In Vitro Anticancer Activity of Isolated Novel Marker Compound from Chemically Modified Bioactive Fraction from Curcuma longa (NCCL). Naqvi, A., Malasoni, R., Gupta, S., et al.[2022]

The safety evaluation of CURCUGEN®, an oleoresin-based turmeric extract, showed a very high tolerance in Sprague-Dawley rats, with an LD50 greater than 5000 mg/kg body weight, indicating low toxicity.

In a 90-day study, CURCUGEN® demonstrated a no observed adverse effect level (NOAEL) of 2000 mg/kg body weight/day and did not show any genotoxic or clastogenic effects, confirming its safety for potential use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Oleoresin-Based Turmeric Formulation: Assessment of Genotoxicity and Acute and Subchronic Oral Toxicity. Nirvanashetty, S., Panda, SK., Jackson-Michel, S.[2022]

A new method for measuring curcumin levels in biological samples was developed and validated, showing high accuracy and sensitivity, which is crucial for studying its effects on brain disorders.

In mice, curcumin concentrations in the brain were significantly higher after intraperitoneal injection compared to oral administration, indicating that the method can help understand how curcumin reaches the brain in different delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A validated method for the quantification of curcumin in plasma and brain tissue by fast narrow-bore high-performance liquid chromatography with fluorescence detection. Schiborr, C., Eckert, GP., Rimbach, G., et al.[2019]

Curcumin, a compound found in turmeric, has been linked to various health benefits, including antioxidant and anti-inflammatory effects, supported by over 6,000 research citations and more than 100 clinical studies.

A major challenge with curcumin is its low bioavailability, which affects how well it is absorbed and utilized in the body; this review focuses on different formulations that aim to improve its delivery and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in delivery, bioavailability, absorption and metabolism of curcumin: the golden pigment from golden spice. Prasad, S., Tyagi, AK., Aggarwal, BB.[2022]

Curcumin, derived from turmeric, has demonstrated neuroprotective effects against neurodegenerative diseases like Alzheimer's and Parkinson's in various in vivo and in vitro studies, suggesting its potential as a treatment option.

The review discusses curcumin's mechanisms of action, including its antioxidant and anti-inflammatory properties, as well as challenges related to its bioavailability, which may impact its effectiveness in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Promising Therapeutic Avenues of Curcumin in Brain Diseases. Benameur, T., Giacomucci, G., Panaro, MA., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on the Benefits and Problems of Curcumin with Respect to Human Health. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Curcumin pretreatment attenuates brain lesion size and improves neurological function following traumatic brain injury in the rat. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Farmer to pharmacist: curcumin as an anti-invasive and antimetastatic agent for the treatment of cancer. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

CURCUMA LONGA AS MEDICINAL HERB IN THE TREATMENT OF DIABET- IC COMPLICATIONS. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Neuroprotective effects of curcumin]. [2016]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quercetin-Decorated Curcumin Liposome Design for Cancer Therapy: In-Vitro and In-Vivo Studies. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

A Comprehensive Review on Physiological Effects of Curcumin. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

In Silico and In Vitro Anticancer Activity of Isolated Novel Marker Compound from Chemically Modified Bioactive Fraction from Curcuma longa (NCCL). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Safety Evaluation of Oleoresin-Based Turmeric Formulation: Assessment of Genotoxicity and Acute and Subchronic Oral Toxicity. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

A validated method for the quantification of curcumin in plasma and brain tissue by fast narrow-bore high-performance liquid chromatography with fluorescence detection. [2019]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Recent developments in delivery, bioavailability, absorption and metabolism of curcumin: the golden pigment from golden spice. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

New Promising Therapeutic Avenues of Curcumin in Brain Diseases. [2022]