Cocoa Extract for Migraine

(CORAL Trial)

Overseen By Pamela M Rist, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Stroke, Brain surgery, Kidney failure, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether people with migraines will consistently take a high-dose cocoa extract supplement. Researchers aim to determine if they can enroll enough participants and if these participants will adhere to the pill regimen. The study compares two different doses of cocoa extract to a placebo (a pill with no active ingredient) to assess the acceptability of higher doses for migraine sufferers. Ideal candidates for this trial have experienced migraines for at least a year, suffer from 4 to 14 migraine attacks per month, and are willing to take study pills daily. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could lead to new migraine treatments.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications, but you should not start any new migraine medications or behavioral treatments during the trial. If you are currently using medications to prevent or treat migraines, you must have been on them for at least 3 months before joining the study.

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

Research has shown that cocoa extract can sometimes cause migraine headaches in a small number of people. In studies, chocolate triggered migraines in some participants, with reports ranging from about 1% to 33%. Cocoa can also cause allergic skin reactions in certain cases.

While these reactions might seem concerning, most people tolerate cocoa well. However, individuals with a history of allergies or migraines caused by chocolate should consult the clinical trial team before joining.

Overall, research suggests that cocoa extract is safe for many people, but individual reactions can vary. Those considering joining a trial should seek specific advice from the research staff based on their health history. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cocoa extract for migraines because it offers a natural alternative to standard treatments like triptans and NSAIDs. Unlike these conventional medications, cocoa extract is derived from a natural source and may offer fewer side effects. Additionally, cocoa extract is being investigated for its potential to influence blood flow and reduce inflammation, which could provide a new mechanism of action in migraine relief. This approach not only broadens the scope of available migraine therapies but may also appeal to those seeking natural treatment options.

What evidence suggests that cocoa extract could be an effective treatment for migraines?

Research suggests that cocoa extract, which participants in this trial may receive, might help with migraines by blocking a chemical called CGRP, involved in migraine attacks. Lab studies have shown that cocoa extract can potentially stop CGRP from being released without causing harm. This could reduce the frequency or severity of migraines. However, limited evidence from human studies exists to show a direct link between cocoa and migraine relief. While the idea is promising, further research is needed to confirm its effectiveness in real life. ^{1 4 6 7 8}

Who Is on the Research Team?

Pamela M Rist, ScD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who have had migraines for at least a year, experience 4 to 14 attacks per month, and haven't started new migraine treatments in the past three months. Participants must be willing to take study pills daily, provide urine samples, complete questionnaires, and not begin any new behavioral interventions during the trial.

Inclusion Criteria

I have had migraines for at least one year.

I have had 4 to 14 migraine attacks in the last month.

I haven't started any new mental health treatments in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Run-in

Participants record their migraines and complete baseline questionnaires

4 weeks

Treatment

Participants take four study pills a day and complete daily questionnaires

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cocoa Extract

Trial Overview The study tests high-dose cocoa extract supplements against a placebo in people with episodic migraines. It aims to see if participants can be recruited effectively and will adhere to taking four pills daily over a period of 12 weeks while tracking their migraine frequency.

How Is the Trial Designed?

Group I: 500 mg cocoa extract Experimental Treatment 1 Intervention

Participants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day

Group II: 1000 mg cocoa extract Experimental Treatment 1 Intervention

Participants assigned to this arm will take four 250 mg cocoa extract pills per day

Group III: Placebo Placebo Group 1 Intervention

Participants assigned to this arm will take four placebo pills per day.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7146545/

A Review of the Relationship between Chocolate and Migraines Although there is a lack of data showing the beneficial effect of chocolate on migraines, theoretically such a link is possible. First of all, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06808230?cond=Cocoa&viewType=Table&rank=3

Study Details | NCT06808230 | Cocoa Extract for Migraine ... The goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed ...

3. migrainecollaborative.org migrainecollaborative.org/a-role-for-nutraceuticals-in-the-treatment-of-migraine-a-chat-with-paul-durham

A Role for Nutraceuticals in the Treatment of Migraine We found that cocoa worked to inhibit CGRP [calcitonin gene-related peptide] release in vitro without toxicity, which in vivo blocked trigeminal ...

4. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/search?q=Migraine

Search - Migraine - Rally | Research Studies We are performing a pilot study of a cocoa extract supplement for episodic migraine to help inform the design of a future large scale trial.

5. researchgate.net researchgate.net/publication/18329594_Effect_of_chocolate_in_migraine_A_double-blind_study

(PDF) Effect of chocolate in migraine: A double-blind study Only 13 headaches occurred to chocolate alone in 80 subject sessions, and only two subjects responded consistently to chocolate in the two ...

6. cambridgecommodities.com cambridgecommodities.com/ingredients/ingredient-view,cocoa-extract-24-theobromine_2269.htm?msds=P03358

Cocoa Extract 24% Theobromine If fumes or combustion products are inhaled remove from contaminated area. Lay patient down. Keep warm and rested.

7. vigon.com vigon.com/product/cocoa-extract-milk-chocolate-ivory-coast-blend/?doc=MSDS/505125_vigon_sds_us_english.pdf&namee=CocoaExtractMilkChocolateIvoryCoastBlendSDS

505125 COCOA EXTRACT MILK CHOCOLATE (IVORY ... Information on likely routes of exposure. Inhalation. May cause drowsiness or dizziness. Headache. Nausea, vomiting. May cause irritation to the.

8. webmd.com webmd.com/vitamins/ai/ingredientmono-812/cocoa

Cocoa - Uses, Side Effects, and More Cocoa can cause allergic skin reactions and might also trigger migraine headaches. ... Effects of cocoa extract and dark chocolate on angiotensin-converting ...