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

Recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

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.

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 the high-fat meal test safe for women with migraines?

The research articles provided do not contain specific safety data for the high-fat meal test or related tests like Flow-mediated dilation testing, Mixed meal tolerance testing, or Skin conductance & cold pressor test. Therefore, no relevant safety information is available from these studies. ^{1 2 3 4 5}

How does mixed meal tolerance testing differ from other treatments for migraine-related cardiovascular risk?

Mixed meal tolerance testing is unique because it involves assessing the body's response to a high-fat meal, which can provide insights into how dietary fats affect cardiovascular risk in women with migraines. Unlike standard treatments that might focus on medication or lifestyle changes, this approach directly examines the metabolic impact of specific dietary components. ^{6 7 8 9 10}

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.

Timeline

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

Treatment Details

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.

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Healthy Eating Plate Advice for Migraine Prevention: An Interventional Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Effects of the Dietary Approaches to Stop Hypertension (DASH) diet on clinical, quality of life and mental health outcomes in women with migraine: a randomised controlled trial. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Macronutrient Intake in Relation to Migraine and Non-Migraine Headaches. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Associations between adherence to dietary approaches to stop hypertension (DASH) diet and migraine headache severity and duration among women. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Food allergy and adult migraine: double-blind and mediator confirmation of an allergic etiology. [2005]

6. England pubmed.ncbi.nlm.nih.gov

Associations between adherence to the Danish Food-Based Dietary Guidelines and cardiometabolic risk factors in a Danish adult population: the DIPI study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Fish, n-3 fatty acids, and cardiovascular diseases in women of reproductive age: a prospective study in a large national cohort. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Margarine intake and risk of nonfatal acute myocardial infarction in Italian women. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Circulating biomarkers of dairy fat and risk of incident stroke in U.S. men and women in 2 large prospective cohorts. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Association between dairy food consumption and risk of myocardial infarction in women differs by type of dairy food. [2023]