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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fmd is measured at baseline and 2.5 hours after mmtt.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I have been diagnosed with migraines, experiencing 1-10 days of migraine a month.
Select...
I am a woman aged between 18 and 35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fmd is measured at baseline and 2.5 hours after mmtt.
This trial's timeline: 3 weeks for screening, Varies for treatment, and fmd is measured at baseline and 2.5 hours after mmtt. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
LPS area under the curve (AUC)
Secondary outcome measures
Flow-mediated dilation (FMD)
Sympathetic tone at rest and with painful stimulus

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
1,992 Previous Clinical Trials
42,875,330 Total Patients Enrolled
Ana Recober, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
Shana E McCormack, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
4 Previous Clinical Trials
169 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial currently have openings for participants?

"The clinicaltrials.gov website confirms that the trial is no longer recruiting patients, having been posted on April 1st 2017 and last updated October 3rd 2022. However, there are 173 other medical studies currently in search of participants."

Answered by AI

Is my profile suitable to participate in this trial?

"This medical trial is seeking 30 volunteers aged 18-35 and suffering from sick headache. To be eligible, these individuals must also possess a body mass index of between 18.5 to 24.9 kg/m2 or higher than 30kg/m2 if female."

Answered by AI

Are senior citizens allowed to participate in this trial?

"This research is enrolling adults who are aged 18-35 years old."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~4 spots leftby Mar 2025