Resveratrol + Quercetin + Curcumin for Age-Related Macular Degeneration

Overseen By Stephanie Aman, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Paul A Knepper, MD PhD

Must not be taking: Anticoagulants

Disqualifiers: Wet AMD, Alzheimer's, Dementia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of three natural substances: resveratrol, quercetin, and curcumin (a compound found in turmeric). It targets individuals with dry age-related macular degeneration (AMD), a condition that leads to vision loss. The researchers aim to determine if this combination can slow down or improve the condition over two years. Individuals with dry AMD who can take oral medication might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticoagulant medication (blood thinners) at least 5 days before starting the study. For other medications, the protocol does not specify if you need to stop taking them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of resveratrol, quercetin, and curcumin (RQC) offers potential health benefits. These ingredients possess antioxidant properties, which help protect cells from damage.

Previous studies have found that resveratrol is generally safe when consumed in amounts similar to those in foods, though less is known about its safety in larger doses. Some research suggests it may support heart and brain health and other conditions.

Curcumin, commonly found in turmeric, is considered safe and is recognized by the FDA as "Generally Recognized as Safe" (GRAS). It does not contain harmful materials requiring strict regulation.

Quercetin, commonly found in foods and used as a supplement, is usually well-tolerated, with only minor side effects reported at higher doses.

As this is a Phase 2 trial, initial safety testing has already been conducted, indicating acceptable safety in earlier studies. However, further research is needed to confirm their safety and effectiveness for treating age-related macular degeneration (AMD). Discussing potential risks and benefits with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Resveratrol, Quercetin, and Curcumin (RQC) for age-related macular degeneration (AMD) because these compounds are known for their antioxidant and anti-inflammatory properties, which are not typical in standard treatments. Unlike existing treatments like anti-VEGF injections, which primarily target excess blood vessel growth in the eye, RQC aims to protect retinal cells from oxidative stress and inflammation, potentially addressing underlying causes of AMD. Additionally, each component of RQC is derived from natural sources, offering a novel approach that could complement or even enhance the current standard of care for AMD.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

This trial will evaluate the effects of resveratrol, quercetin, and curcumin used together in one treatment arm, and curcumin alone in another. Research has shown that resveratrol, quercetin, and curcumin together have strong antioxidant effects that may aid in reducing inflammation and promoting cell health. Resveratrol can lessen disease severity by influencing processes that control inflammation and cell death. Curcumin, found in turmeric, may reduce pain, improve joint function, and benefit heart health and inflammation. Quercetin, a plant compound, possesses antioxidant properties and may help reduce inflammation. Together, these compounds might slow age-related macular degeneration (AMD) by protecting eye cells from damage. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul A Knepper, MD, PhD

Principal Investigator

Zaparackas Knepper, Ltd

Zibute Zaparackas, MD

Principal Investigator

Zaparackas Knepper, Ltd

Are You a Good Fit for This Trial?

Inclusion Criteria

Male or female of any race or ethnicity.

Aged 50-90 years at time of study entry.

Ability to speak, read, and understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either RQC or curcumin alone for AMD over 24 months

24 months

Follow-up visits at least every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Curcumin
• Quercetin
• Resveratrol

How Is the Trial Designed?

Group I: Resveratrol, Quercetin, Curcumin (RQC) Experimental Treatment 1 Intervention

Resveratrol (100mg BID), Quercetin (120mg BID), Curcumin (1000mg BID); 24 months

Group II: Curcumin Active Control 1 Intervention

Curcumin (1000mg BID); 24 months

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?

Paul A Knepper, MD PhD

Lead Sponsor

Trials

1

Recruited

150+

Published Research Related to This Trial

Tetrahydrocurcuminoids from turmeric have been evaluated and deemed safe for consumption at a maximum level of 140 mg/day for adults, which is lower than the proposed dose of 300 mg/day.

The evaluation included a 90-day oral toxicity study and showed no concerns regarding genotoxicity, indicating that tetrahydrocurcuminoids do not pose significant health risks when consumed within the established safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283. Turck, D., Bohn, T., Castenmiller, J., et al.[2022]

Curcumin, the active compound in turmeric, has been shown to have multiple health benefits, including anti-inflammatory and anticancer properties, by regulating various proteins and enzymes involved in cell growth and survival.

Clinical trials indicate that curcumin is safe for consumption at high doses (up to 12g daily for 3 months) and may have therapeutic potential in treating a variety of diseases, including cancer, inflammatory bowel disease, and arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin as "Curecumin": from kitchen to clinic. Goel, A., Kunnumakkara, AB., Aggarwal, BB.[2022]

CuminUP60®, a curcumin complex derived from Curcuma longa L., demonstrated no mutagenic effects in various safety studies, indicating it is safe for use.

In toxicity studies involving Sprague-Dawley rats, a single dose of 5000 mg was well tolerated, and the no observed adverse effect level (NOAEL) was established at 1000 mg/kg bw/day over a 4-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of CuminUP60® - A novel curcumin complex. Dziwenka, M., Li, X., Li, W., et al.[2022]

Curcuma species, particularly C. longa, C. aromatica, and C. xanthorrhiza, are widely used in traditional medicine for treating various health issues, including indigestion and diabetes, due to their active compounds like curcumin.

Research from 1976 to 2008 highlights curcumin's significant anti-inflammatory, antioxidant, and potential anti-cancer properties, revealing its therapeutic mechanisms and genomic effects, which support its use in modern medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the investigation of curcuminoids. Itokawa, H., Shi, Q., Akiyama, T., 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]

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]

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 active compound in turmeric, has demonstrated a wide range of therapeutic effects, including antioxidant, anti-inflammatory, and anticancer properties, making it potentially beneficial for various chronic diseases such as diabetes, arthritis, and Alzheimer's disease.

Research indicates that curcumin's effects are mediated through the regulation of key biological pathways, similar to those targeted by modern medications like tumor necrosis factor blockers and growth factor inhibitors, suggesting its role as a multitargeted therapeutic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curcumin: the Indian solid gold. Aggarwal, BB., Sundaram, C., Malani, N., et al.[2022]

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Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.