Curcumin + Astaxanthin for Triglycerides

Overseen By Robert DiSilvestro, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medinutra LLC

Disqualifiers: Diabetes, Cancer, Lupus, others

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether two dietary supplements, curcumin and astaxanthin, can help maintain healthy triglyceride levels. Participants will take one capsule daily for six weeks, and researchers will compare the effects to a placebo. The trial focuses on individuals with moderately high triglyceride levels (140-250 mg/dL) who do not have uncontrolled diabetes or other major health issues. As an unphased trial, it offers participants the chance to contribute to foundational research that could inform new dietary recommendations.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

A previous study found that astaxanthin did not cause any problems in blood tests, indicating no negative effects on health markers. Another report found it generally safe and available over-the-counter, suggesting good tolerance. However, some cases of liver changes occurred, so monitoring liver health is important.

Research has shown that curcumin, found in turmeric, is usually safe and well-tolerated. The FDA considers it "Generally Regarded as Safe" (GRAS), indicating it is typically safe for most people. Some studies have shown it can improve blood fat levels without causing harm.

Overall, both astaxanthin and curcumin appear well-tolerated, with no major issues reported in many studies. However, it is important to pay attention to how the body reacts. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using curcumin and astaxanthin for managing triglycerides because these compounds are derived from natural sources with antioxidant properties that might offer a new approach to treatment. Unlike standard treatments for high triglycerides, which often involve pharmaceutical options like statins or fibrates, curcumin and astaxanthin may provide benefits with fewer side effects due to their natural origins. Curcumin, especially in its Longvida™ formulation, is known for its enhanced bioavailability, meaning the body can absorb it more effectively. Astaxanthin also stands out for its strong antioxidant ability, which could help reduce inflammation and potentially improve heart health. This natural and potentially safer alternative is why there's buzz around these treatments in the medical community.

What evidence suggests that this trial's treatments could be effective for maintaining triglycerides in the normal range?

This trial will compare the effects of Astaxanthin and Curcumin on triglyceride levels. Research has shown that Astaxanthin, which participants in this trial may receive, can help lower triglyceride levels. In one study, triglycerides decreased from 151 mg/dL to 112 mg/dL after taking Astaxanthin. Another study found improvements in cholesterol and triglycerides, although some research did not find significant changes with Astaxanthin use.

Curcumin, especially in the Longvida form, is another treatment option in this trial. Evidence from several studies indicates that Curcumin can significantly reduce triglycerides and improve cholesterol levels by affecting genes involved in fat production. Overall, both supplements have shown potential in managing triglyceride levels. ^{5 6 7 8 9}

Who Is on the Research Team?

Robert DiSilvestro, Ph.D.

Principal Investigator

Medinutra LLC

Are You a Good Fit for This Trial?

Adults aged 21-59 with moderately high triglyceride levels (140-250 mg/dL) are eligible for this trial. It's designed to see if certain dietary supplements can help maintain normal triglyceride levels and reduce inflammation.

Inclusion Criteria

My triglyceride levels are between 140-250 mg/dL.

I am between 21 and 59 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one capsule per day of either Longvida Curcumin, astaxanthin, or a placebo for 6 weeks

6 weeks

2 visits (in-person) for blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Astaxanthin
• Curcumin (Longvida™)

Trial Overview The trial is testing the effects of two dietary supplements, Curcumin (Longvida™) and Astaxanthin, each compared to a placebo. Participants will take one capsule daily for six weeks while their serum triglycerides and some blood markers of inflammation are monitored.

How Is the Trial Designed?

Group I: Regular dose curcumin Experimental Treatment 1 Intervention

Subjects will be given 1 capsule per day of a typical amount of Longvida curcumin (80 mg curcumin)

Group II: Low dose curcumin Experimental Treatment 1 Intervention

Subjects will be given 1 capsule per day of 40 mg curcumin which is half the typical amount of Longvida curcumin

Group III: Astaxanthin Experimental Treatment 1 Intervention

Subjects will be given 1 capsule per day of a typical amount of astaxanthin (12 mg curcumin)

Group IV: Control Placebo Group 1 Intervention

Subjects will be given 1 capsule per day of a small amount of cellulose

Who Is Running the Clinical Trial?

Medinutra LLC

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12389351/

Assessing the Effects of Moderate to High Dosage ... In the assessment of triglyceride levels, results show a decrease from 151 ± 26 mg/dL (pre-intervention) to 112 ± 40 mg/dL (post-intervention) ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1756464623005376

Astaxanthin as a metabolic regulator of glucose and lipid ... Astaxanthin showed an improved adiponectin level, a significant increase in HDL-C, and a decrease in plasma levels of total cholesterol, triglycerides, and non- ...

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15070

Astaxanthin, a natural antioxidant, lowers cholesterol and ... After 24 weeks, astaxanthin treatment significantly decreased low-density lipoprotein (−0.33 ± 0.11 mM) and total cholesterol (−0.30 ± 0.14 mM) ...

4. archivesofmedicalscience.com archivesofmedicalscience.com/pdf-53588-58297?filename=58297.pdf

Lipid profile and glucose changes after supplementation ... Conclusions: This meta-analysis of data from 10 RCT arms did not indicate a significant effect of supplementation with astaxanthin on plasma ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/56/NCT07063056/Prot_SAP_000.pdf

Curcumin and Astaxanthin for Lowering Triglyceride ... A secondary hypothesis is that the supplementation will raise HDL cholesterol readings and depress values for two markers of inflammation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9687027/

Safety Assessment of 3S, 3'S Astaxanthin Derived from ... Treatment with astaxanthin over a period of time showed no adverse effects on the clinical chemistry parameters (Table 4). Nevertheless, ...

7. efsa.europa.eu efsa.europa.eu/en/consultations/call/180725

Call for data relevant to the safety assessment of Astaxanthin ... In this study statistically significant increased incidences of hepatocellular vacuolation, hepatocellular hypertrophy and multinuclear ...

8. downloads.regulations.gov downloads.regulations.gov/FDA-2020-S-0023-0106/content.pdf

FDA New Dietary Ingredient Notification Safety Information therefore concluded that astaxanthin could be used to treat impaired lipid metabolism and prevent atherosclerosis. A lack of adverse effects ...

9. webmd.com webmd.com/vitamins-and-supplements/astaxanthin

Astaxanthin: Health Benefits, Uses, Risks and Side Effects Astaxanthin is generally safe. The FDA does not regulate dietary supplements like medications. Instead, they're treated like food. Astaxanthin ...