High-Fat Meal Effects on Cardiovascular Risk in Women with Migraine

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Oral contraceptives, Antibiotics, Steroids, NSAIDs

Disqualifiers: Smoking, Diabetes, Major depression, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a high-fat, high-carb meal affects heart health indicators, such as inflammation and blood flow, in young women with migraines compared to those without. Participants will eat a specific meal and undergo several tests, including mixed meal tolerance testing, to assess how the body processes nutrients. Suitable candidates are women aged 18-35 who experience migraines 1-10 days per month and are either of normal weight or classified as obese. Participants must be non-smokers and free of certain chronic conditions or recent medication use. As an unphased trial, this study allows participants to contribute to understanding the dietary impacts on heart health and migraines.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any chronic medications, including oral contraceptives, to participate in this trial.

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

Research shows that the high-fat, high-carbohydrate meal used in the study is generally safe for participants. Similar studies have reported no major safety issues. These meals help researchers understand how the body reacts to food and are usually well-tolerated by most people.

Participants in past studies did not experience any serious unexpected medical problems. The study examines how the meal affects factors like inflammation and blood flow, without introducing new drugs or treatments. This approach keeps the risk of serious side effects low.

The study's design confirms the meal's safety by using only ingredients found in a regular diet, albeit in a controlled manner. Participants can feel reassured that their safety remains a top priority in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the high-fat meal effects protocol because it explores how dietary habits might influence cardiovascular risk, particularly in women with migraines. Unlike standard treatments for migraines, which typically focus on pain relief through medications like triptans or NSAIDs, this study investigates the body's response to food intake and its potential cardiovascular implications. By using a mixed meal tolerance test alongside other methods like skin conductance and flow-mediated dilation testing, this approach offers a comprehensive view of how metabolism and cardiovascular health interact in the presence of migraines and obesity. This could potentially lead to more personalized dietary recommendations for those suffering from migraines, aiming to reduce cardiovascular risks.

What evidence suggests that this trial's treatments could be effective for cardiovascular risk in women with migraine?

Research has shown that people with migraines face a higher risk of heart disease. This trial explores how a specific type of meal might impact heart health in women who experience migraines. Participants will undergo mixed meal tolerance testing, skin conductance and cold pressor tests, and flow-mediated dilation testing. Early results suggest that meals high in fat and carbohydrates can affect inflammation and blood vessel function. However, past studies have not clearly demonstrated how these meals alter specific blood flow measurements. Understanding these effects could help determine if dietary changes might reduce heart disease risk for those with migraines. ^{1 6 7 8 9}

Who Is on the Research Team?

Shana McCormack

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for young adult women aged 18-35 with migraines, comparing them to healthy peers. It includes both normal weight and obese participants but excludes those outside the BMI range of 18.5-24.9 or above 30.

Inclusion Criteria

I am a woman aged between 18 and 35.

BMI 18.5-24.9 kg/m2, inclusive

BMI ≥30 kg/m2

Exclusion Criteria

Smoking (current or former)

Pregnant or nursing

Allergies or sensitivity to any of the ingredients of the meal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (telephone)

Study Visit

Participants undergo mixed meal tolerance testing, skin conductance & cold pressor test, and flow-mediated dilation testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study visit

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Flow-mediated dilation testing
• Mixed meal tolerance testing
• Skin conductance & cold pressor test

Trial Overview The study tests how a high-fat, high-carb meal affects potential cardiovascular disease risk factors like inflammation and vascular response in women with migraines versus those without.

How Is the Trial Designed?

Group I: No migraine, obese Experimental Treatment 3 Interventions

* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing

Group II: No migraine, normal weight Experimental Treatment 3 Interventions

* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing

Group III: Migraine, obese Experimental Treatment 3 Interventions

* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing

Group IV: Migraine, normal weight Experimental Treatment 3 Interventions

* Mixed meal tolerance testing * Skin conductance \& cold pressor test * Flow-mediated dilation testing

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03081390

Study Details | Migraine and CVD Risk in Women The primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed meal on candidate modulators of cardiovascular disease risk ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39308427/

Microvascular effects of a mixed meal tolerance test Results: No consistent effects of the MMTT were detected on LSCI LTH, PLM and SDFM endpoints. LSCI PORH maximum perfusion was significantly ...

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2681442

Evaluation of Galcanezumab for the Prevention of Episodic ... Meaning Galcanezumab demonstrated clinically and statistically significant benefits across several migraine-relevant outcomes in this study, ...

4. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-025-02002-6

Migraine and increased cardiovascular disease risk Migraine has been linked to a heightened risk of cardiovascular disease, and acute treatment drugs, such as triptans, might increase this risk.

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1044465/pdf

Association between migraine and cardiovascular disease migraine, this study aims to explore the association between migraine and CVD using data from the National Health and. Nutrition Examination ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03081390/migraine-and-cvd-risk-in-women

Migraine and CVD Risk in Women | Clinical Research Trial ... The primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed meal on candidate modulators of cardiovascular ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7192290/

The Association Between Migraine, Metabolic Syndrome ... The aim of this study was to examine the relationship between migraines and obesity, insulin resistance (IR), and metabolic syndrome in female migraineurs.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12036269/

Migraine and increased cardiovascular disease risk Migraine has been linked to a heightened risk of cardiovascular disease, and acute treatment drugs, such as triptans, might increase this risk.

9. researchgate.net researchgate.net/publication/309631308_Migraine_A_disorder_of_metabolism

Migraine: A disorder of metabolism? | Request PDF ... study reported no significant relation between skipping a meal and migraine ... Since both migraine and MetS are associated with a high risk of cardiovascular ...