Lean Pork for Perimenopause

(LEAP Trial)

Overseen By Hannah E Cabre, PhD, RDN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Lipid-lowering, Phosphodiesterase-5, Corticosteroids, others

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 5

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to examine the impact of a diet high in fresh lean pork, compared to a plant-based diet, on cardiovascular function and vasomotor symptoms in perimenopausal women with overweight and obesity. The main questions it aims to answer are: 1. How does a diet high in pork, compared to a plant-based diet, affects blood lipids, endothelial function, and blood pressure? 2. How does a diet high in pork, compared to a plant-based diet, affects blood nitrate, cardiometabolic biomarkers, inflammatory biomarkers, and vasomotor symptoms? Researchers will compare the diet high in pork to a plant-based diet to see if pork helps improve cardiovascular and mesopause symptoms. Participants will: * Consume both of the diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets trials * Visit the clinic 5 times with weekly meal pick ups during the diet trials * Undergo testing procedures including: weight and body composition, blood pressure and pulse, endothelial function using ultrasound of upper arm, microvascular blood flow, blood draws, physical activity measurements, and questionnaires.

Research Team

Hannah E Cabre, PhD, RDN

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

This trial is for perimenopausal women who are overweight or obese. They should be willing to follow two different diets (pork-based and plant-based) each for 4 weeks, with a break in between. Participants must visit the clinic regularly and undergo various tests like blood pressure checks, ultrasounds, and questionnaires.

Inclusion Criteria

Are experiencing irregular menstrual cycles but have not gone longer than 12 consecutive months without a period

Are doing less than 3 hours per week of structured exercise

Have systolic blood pressure between 120 and 140 mmHg and/or diastolic blood pressure between 80 and 90 mmHg

Exclusion Criteria

Has systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg

Food allergies or other reasons preventing consumption of study foods with both study diets

I currently smoke or vape and/or drink heavily.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants consume a diet high in pork or a plant-based diet for 4 weeks each, with a washout period in between

10-14 weeks

5 visits with weekly meal pickups

Follow-up

Participants are monitored for changes in cardiovascular function and vasomotor symptoms

4 weeks

Treatment Details

Interventions

• Plant Diet
• Pork Diet

Trial Overview The study compares the effects of a pork diet versus a plant diet on cardiovascular health and menopause symptoms in perimenopausal women. It measures changes in blood lipids, endothelial function, blood pressure, nitrate levels, biomarkers for heart health and inflammation, as well as hot flashes.

Participant Groups

Group I: Pork Diet Experimental Treatment 1 Intervention

All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork.

Group II: Plant Diet Experimental Treatment 1 Intervention

All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+