Antioxidant Cocktail for Stroke Prevention

Overseen By Shawn Bolin, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Cardiovascular medications, NSAIDs

Disqualifiers: Hypertension, Diabetes, Smoking, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special mix of vitamins to see how it affects brain blood flow in healthy young adults. Researchers want to know if men and women respond differently to high oxygen levels.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking all current medications, but it does require stopping hormonal birth control at least one month before the first study visit if it's used for contraception only. Cardiovascular medication use is also an exclusion criterion, so you may need to stop those if applicable.

What data supports the effectiveness of the Antioxidant Cocktail treatment for stroke prevention?

Research shows that antioxidants can help reduce brain damage caused by strokes by neutralizing harmful free radicals. Studies on individual antioxidants like resveratrol and lipoic acid have shown they can protect the brain in animal models of stroke, suggesting potential benefits for humans. ^{1 2 3 4 5}

Is the Antioxidant Cocktail safe for humans?

The research articles provided do not contain specific safety data for the Antioxidant Cocktail in humans. However, they discuss the potential benefits of antioxidants in stroke prevention and treatment, suggesting that antioxidants may have protective effects on the brain. ^{1 2 4 6 7}

How does the antioxidant cocktail treatment for stroke prevention differ from other treatments?

The antioxidant cocktail for stroke prevention is unique because it combines multiple antioxidants, potentially enhancing neuroprotection by reducing brain damage from free radicals during a stroke. Unlike conventional treatments, this approach uses a combination of ingredients like resveratrol and lipoic acid, which have shown promise in animal models for reducing stroke damage. ^{2 3 4 8 9}

Research Team

William G Schrage, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

Healthy adults aged 18-40 can join this study on reactive oxygen species and brain blood flow. Excluded are those with high blood pressure, glucose levels, or a history of heart, liver, kidney diseases; smokers; certain medication users; MRI contraindications; women with irregular menstrual cycles or using hormonal birth control (except copper IUDs).

Inclusion Criteria

I am between 18 and 40 years old.

Exclusion Criteria

You are sensitive to NSAIDs (non-steroidal anti-inflammatory drugs).

I am taking medication for my heart condition.

I have been diagnosed with sleep apnea.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo CBF testing in MRI under normoxia and hyperoxia conditions with either placebo or antioxidant cocktail

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Antioxidant Cocktail
• Placebo

Trial Overview The trial is testing an antioxidant cocktail against a placebo in 30 healthy participants to understand its effect on cerebral blood flow. The study spans over six months with two visits.

Participant Groups

Group I: Antioxidant Cocktail Experimental Treatment 1 Intervention

The first dose will be 500 mg vitamin C, 200 IU vitamin E, and 300 mg of alpha lipoic acid 120 minutes before MRI. The second dose will be 500 mg vitamin C, 400 IU vitamin E, and 300 mg of alpha lipoic acid 60 minutes before MRI.

Group II: Placebo Active Control 1 Intervention

Placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a multicenter, randomized, placebo-controlled study involving 252 acute ischemic stroke patients, edaravone showed a significant improvement in functional outcomes compared to placebo, as measured by the modified Rankin Scale (p = 0.0382).

Edaravone acts as a neuroprotective agent by inhibiting vascular endothelial cell injury and reducing neuronal damage, suggesting its potential as an effective treatment for acute ischemic stroke when administered within 72 hours of onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a novel free radical scavenger, edaravone (MCI-186), on acute brain infarction. Randomized, placebo-controlled, double-blind study at multicenters. [2022]

In a study involving 48 acute ischaemic stroke patients, supplementation with antioxidants (800 IU of alpha-tocopherol and 500 mg of vitamin C) within 12 hours of stroke onset significantly increased antioxidant levels and total antioxidant capacity compared to a control group.

The treatment group also showed a significant reduction in plasma malondialdehyde (MDA), indicating less oxidative damage, and lower C-reactive protein (CRP) levels, suggesting a potential anti-inflammatory effect after 14 days of supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antioxidant supplementation enhances antioxidant capacity and mitigates oxidative damage following acute ischaemic stroke. Ullegaddi, R., Powers, HJ., Gariballa, SE.[2013]

Antioxidant compounds may offer potential benefits in preventing or treating acute ischemic stroke by reducing brain damage caused by excessive free radicals, as highlighted in various observational studies and clinical trials.

Promising antioxidants such as dehydroascorbic acid, alpha-tocotrienol, and flavonoids have shown effectiveness in animal models, but there are challenges in translating these results to human patients, indicating a need for improved research methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary antioxidants as potential pharmacological agents for ischemic stroke. Cherubini, A., Ruggiero, C., Morand, C., et al.[2019]

In a study involving male Sprague-Dawley rats, pretreatment with resveratrol significantly reduced brain damage after ischemic stroke, showing its potential as a neuroprotective agent when administered before or shortly after blood flow is restored.

Combining low doses of resveratrol with lipoic acid also provided significant neuroprotection, and a new compound (UPEI-201) created from these two showed promise in protecting against ischemia-induced damage, suggesting a multi-pathway approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-administration of resveratrol and lipoic acid, or their synthetic combination, enhances neuroprotection in a rat model of ischemia/reperfusion. Saleh, MC., Connell, BJ., Rajagopal, D., et al.[2021]

In a study of 72 stroke patients over 12 months, supplementation with n-3 fatty acids showed a trend towards lower mortality rates, suggesting potential benefits for stroke survivors' long-term health.

Despite the lack of significant differences in rehabilitation outcomes among the treatment groups, the study highlighted the prevalence of malnutrition in stroke patients, indicating that dietary supplementation may be important for improving overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is antioxidant and n-3 supplementation able to improve functional status in poststroke patients? Results from the Nutristroke Trial. Garbagnati, F., Cairella, G., De Martino, A., et al.[2022]

A systematic review of 10 studies involving 387,076 participants found that higher intakes of flavanones are linked to a reduced risk of stroke, with a relative risk of 0.85 for those consuming the highest amounts compared to the lowest.

Flavan-3-ols also showed a potential protective effect against stroke, with a 14% reduction in risk associated with a daily increase of 200 mg, suggesting that foods rich in these flavonoids, like citrus fruits, may help lower stroke risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of prospective cohort studies of flavonoid subclasses and stroke risk. Li, XQ., Wang, C., Yang, T., et al.[2022]

Diet plays a significant role in reducing the risk of stroke, particularly in the elderly, due to the presence of bioactive compounds with antioxidant and anti-inflammatory properties.

Several dietary bioactive compounds have shown promising results in reducing cerebral damage in models of cerebral ischemia, suggesting they could be potential candidates for new neuroprotective strategies to protect the brain before a stroke occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective diets for stroke. Ayuso, MI., Gonzalo-Gobernado, R., Montaner, J.[2018]

Antioxidants may help reduce ischemic cerebral injury by decreasing arterial vasospasm and infarct size, but clinical evidence supporting these benefits is still lacking.

Light-to-moderate alcohol intake could protect against atherosclerosis, a major cause of ischemic stroke, by preventing LDL oxidation and reducing platelet aggregation, although heavy drinking may worsen ischemic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxidants, antioxidants, alcohol and stroke. Hillbom, M.[2021]

Conventional radical scavenging antioxidants have shown limited effectiveness in treating ischemic stroke, highlighting the need for more potent alternatives.

NXY-059, a spin trap nitrones agent, has demonstrated effectiveness in animal models of cerebral ischemia and is currently undergoing phase III clinical trials, suggesting promising potential for treating ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrone spin on cerebral ischemia. Doggrell, SA.[2007]

References

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

Effect of a novel free radical scavenger, edaravone (MCI-186), on acute brain infarction. Randomized, placebo-controlled, double-blind study at multicenters. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Antioxidant supplementation enhances antioxidant capacity and mitigates oxidative damage following acute ischaemic stroke. [2013]

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

Dietary antioxidants as potential pharmacological agents for ischemic stroke. [2019]

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

Co-administration of resveratrol and lipoic acid, or their synthetic combination, enhances neuroprotection in a rat model of ischemia/reperfusion. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Is antioxidant and n-3 supplementation able to improve functional status in poststroke patients? Results from the Nutristroke Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of prospective cohort studies of flavonoid subclasses and stroke risk. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Neuroprotective diets for stroke. [2018]

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

Oxidants, antioxidants, alcohol and stroke. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Nitrone spin on cerebral ischemia. [2007]