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High-Fat Meal Effects on Cardiovascular Risk in Women with Migraine
N/A
Waitlist Available
Led By Ana Recober, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of migraine per ICHD-3-beta (1-10 migraine days per month) for cases only
Female 18-35 years of age, inclusive
Must not have
Treatment with antibiotics or steroids within the previous 3 months
Major medical or psychiatry illness (e.g. diabetes, fibromyalgia, major depression/anxiety)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fmd is measured at baseline and 2.5 hours after mmtt.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the effects of a high-fat, high-carbohydrate meal on various cardiovascular disease risk factors in young women with and without migraine, comparing obese and normal weight women in each group.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the flow-mediated dilation test, skin reactions or pain during the cold pressor test, and digestive changes after the mixed meal tolerance testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with migraines, experiencing 1-10 days of migraine a month.
Select...
I am a woman aged between 18 and 35.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken antibiotics or steroids in the last 3 months.
Select...
I have a major illness like diabetes or severe depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fmd is measured at baseline and 2.5 hours after mmtt.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fmd is measured at baseline and 2.5 hours after mmtt.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
LPS area under the curve (AUC)
Secondary study objectives
Flow-mediated dilation (FMD)
Sympathetic tone at rest and with painful stimulus
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: No migraine, obeseExperimental Treatment3 Interventions
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Group II: No migraine, normal weightExperimental Treatment3 Interventions
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Group III: Migraine, obeseExperimental Treatment3 Interventions
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Group IV: Migraine, normal weightExperimental Treatment3 Interventions
* Mixed meal tolerance testing
* Skin conductance \& cold pressor test
* Flow-mediated dilation testing
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,077 Previous Clinical Trials
42,720,055 Total Patients Enrolled
Ana Recober, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
Shana E McCormack, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
4 Previous Clinical Trials
89 Total Patients Enrolled
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