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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Shana McCormack

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this 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 disease risk (inflammation, vascular reactivity, sympathetic nervous system tone, and response to pain) in young adult women with migraine compared with healthy young women. This is study enrolling both cases (women with migraine) and controls (women without migraine), with equal numbers of normal weight and obese women in each group. Participants will undergo a telephone screening and a single day in-person study visit.

Research Team

Shana McCormack

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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)

I regularly take medications, including birth control pills.

I have a major illness like diabetes or severe depression.

Treatment Details

Interventions

• Flow-mediated dilation testing (Behavioural Intervention)
• Mixed meal tolerance testing (Behavioural Intervention)
• Skin conductance & cold pressor test (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania