What side effects are associated with this type of intervention?

Common treatments for inflammation with antioxidant and anti-inflammatory properties, such as dietary antioxidants and NSAIDs, can have various side effects. Dietary antioxidants, including flavanols found in cocoa, are generally well-tolerated but may cause gastrointestinal discomfort in some individuals. NSAIDs, such as aspirin and ibuprofen, are effective in reducing inflammation but can lead to gastrointestinal issues like ulcers and bleeding, as well as increased risk of cardiovascular events with long-term use. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

Several FDA-approved treatments for inflammation possess antioxidant and anti-inflammatory properties. Notable examples include nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin and ibuprofen, which inhibit cyclooxygenase (COX) enzymes to reduce inflammation. Additionally, corticosteroids such as prednisone are widely used for their potent anti-inflammatory effects. While specific antioxidant treatments like cocoa-derived dietary flavanols are still under investigation, vitamin E has been studied for its antioxidant properties and potential benefits in conditions like Alzheimer's disease. However, more research is needed to confirm the efficacy of antioxidants in treating inflammation.

What other types of research exist?

Promising novel alternatives to cocoa-derived dietary flavanol for inflammation patients include: 1) Green tea catechins, which have demonstrated anti-inflammatory and antioxidant properties. 2) Omega-3 polyunsaturated fatty acids, which have been shown to reduce inflammation and the risk of recurrent gout flares. 3) Vitamin C, which has a mild urate-lowering effect and potential anti-inflammatory benefits. 4) The DASH diet, which has been associated with reduced serum uric acid levels and may help manage inflammation.

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Flavanol

Cocoa Flavanols for Memory Loss

N/A

Waitlist Available

Led By Richard P. Sloan, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 50 and 69 years, both inclusive

Healthy Male or Female subjects. (Females must be post-menopausal)

Must not have

Uncomfortable completing memory and attention tasks in the English language

HIV positive status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

This trial is testing a substance found in cocoa beans to see if it can help improve brain health and thinking abilities in healthy people aged 50-69. Participants will take the cocoa substance for a few months. The study will also look at how inflammation might play a role in these effects. Cocoa products rich in flavonoids have been shown to significantly reduce blood pressure in several studies.

Who is the study for?

This trial is for healthy individuals aged 50-69, with a BMI of 18.0-35 kg/m². Participants must be able to consent, post-menopausal if female, and not have significant health issues or allergies. They shouldn't be on unusual diets, hormone therapies, pregnant/lactating recently, or using certain medications.

What is being tested?

The study tests the effects of cocoa-derived flavanols (650 mg) versus a placebo on brain function and inflammation over 12 weeks in older adults. It's randomized and controlled: participants don't choose which group they're in.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to dietary supplements such as digestive discomfort or allergic reactions for those sensitive to cocoa products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 69 years old.

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I am a healthy individual. If female, I am post-menopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not comfortable doing memory or attention tasks in English.

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I am HIV positive.

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I have Sickle Cell Disease.

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I have had asthma symptoms in the last 3 years.

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I took my medication as instructed during the two-week trial period.

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I have metal fragments in my eye.

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I have a heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HMGB1

Secondary study objectives

NFkB

TNFa

Other study objectives

ModBent

ModRey

multiple cognitive domains

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 650 mg of Cocoapro flavanolsActive Control1 Intervention

Daily, each subject will consume either two cocoa flavanol-containing capsules twice a day with a meal.

Group II: 0mg Cocoapro flavanolsPlacebo Group1 Intervention

Daily, each subject will consume either ttwo placebo-containing capsules twice a day with a meal.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for inflammation often include antioxidants and anti-inflammatory agents. Antioxidants, such as cocoa-derived dietary flavanols, work by neutralizing free radicals, thereby reducing oxidative stress and preventing cellular damage. Anti-inflammatory agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) and certain dietary components like omega-3 fatty acids, inhibit pathways that lead to the production of pro-inflammatory molecules like prostaglandins and cytokines. These mechanisms are crucial for inflammation patients as they help to reduce chronic inflammation, alleviate pain, and prevent tissue damage, ultimately improving overall health and quality of life.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,471 Previous Clinical Trials

2,536,091 Total Patients Enrolled

9 Trials studying Inflammation

13,859 Patients Enrolled for Inflammation

National Institute on Aging (NIA)NIH

1,733 Previous Clinical Trials

28,054,744 Total Patients Enrolled

23 Trials studying Inflammation

4,528 Patients Enrolled for Inflammation

New York State Psychiatric InstituteLead Sponsor

477 Previous Clinical Trials

153,769 Total Patients Enrolled

4 Trials studying Inflammation

871 Patients Enrolled for Inflammation

~39 spots leftby Sep 2025

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