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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a diet high in fresh lean pork compares to a plant-based diet in helping perimenopausal women with overweight or obesity manage cardiovascular health and menopause symptoms. Researchers aim to determine if pork can improve factors like blood pressure and hot flashes. Participants will follow each diet for four weeks, with a break in between, and will visit the clinic for testing and meal pickups. Women experiencing irregular periods and severe menopause symptoms who exercise less than three hours a week might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on menopause and cardiovascular health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as hormone replacement therapy, hormonal contraception, lipid-lowering medications, more than one blood pressure medication, phosphodiesterase-5 inhibitors, anti-coagulants, corticosteroids, metformin, or insulin. If you are on any of these, you would need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a diet rich in fresh lean pork is generally safe and well-tolerated. One study found this diet safe for individuals experiencing perimenopause and those with obesity, with participants not experiencing major side effects.

Studies also show that plant-based diets are safe and well-tolerated. People following plant-based diets often report fewer bothersome symptoms during menopause. These diets are associated with a lower risk of heart disease and other health issues.

Both diets are considered safe and generally well-tolerated by those who try them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring dietary interventions for perimenopause because they offer a natural and potentially effective way to manage symptoms. Unlike conventional treatments like hormone replacement therapy or antidepressants, which can have significant side effects, the experimental use of a pork-based diet or a plant-based diet offers a more holistic approach. The pork diet is rich in nutrients like protein and certain vitamins, which might help in balancing hormones and improving overall well-being. Meanwhile, the plant-based diet is high in fiber and antioxidants, which can support heart health and reduce inflammation. These dietary strategies could provide a gentler alternative for women going through perimenopause, with the potential for fewer side effects.

What evidence suggests that this trial's treatments could be effective for perimenopausal symptoms?

This trial will compare the effects of a Plant Diet and a Pork Diet on perimenopausal symptoms. Studies have shown that a low-fat vegan diet can help reduce body weight and decrease hot flashes, common during perimenopause. People following a vegan diet often report fewer bothersome symptoms like hot flashes compared to those who eat meat. Conversely, research suggests that a diet high in lean pork might improve heart health and ease some menopause symptoms. Lean pork could help improve cholesterol levels and blood pressure, which are important for heart health. Both dietary approaches have shown potential benefits, but they work differently to help with perimenopausal symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Hannah E Cabre, PhD, RDN

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. nature.com nature.com/articles/s41598-025-99406-w

Effects of a healthy diet based on seed-rich vegetables ... A plant-based RSL-rich diet has beneficial effects on the gut microbial composition and brain function of perimenopausal women.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38189863/

Efficacy of plant-derived dietary supplements in improving ... Meta-analysis results indicated significant improvements in all questionnaire scores, including hot flash frequency, in the dietary supplement ...

3. menopause.org menopause.org/press-releases/hot-flashes-may-be-less-bothersome-for-vegans

Hot Flashes May Be Less Bothersome for Vegans Research has shown that a low-fat vegan diet—specifically one supplemented with soybeans—can reduce body weight and hot flashes ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378512218300100

Vegans report less bothersome vasomotor and physical ... Vegans reported less bothersome symptoms than omnivores among perimenopausal women. More vegetable and berry consumption was linked to less bothersome symptoms.

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2529629

Use of Plant-Based Therapies and Menopausal Symptoms In this systematic review and meta-analysis, some plant-based therapies were associated with modest reductions in the frequency of menopausal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257050/

Association of plant-based diet and early onset of natural ... In line with our findings, two previous studies have shown no positive impact of vegetarian diet in delaying menopause onset, contrary, both studies suggested ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2802814

Association of Plant-based Diet Adherence With Risk ... Greater adherence to a healthful plant-based diet was associated with a lower risk of mortality, cancer, and particularly cardiovascular disease.

8. mdpi.com mdpi.com/2227-9032/9/10/1376

Safety Assessment of Endocrine Disruption by Menopausal ... We aimed to determine the effects and safety of menopausal functional health ingredients and medicines on the human body as endocrine disruptors.

9. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(25)00061-3/fulltext

Plant-based dietary patterns and age-specific risk of ... Higher adherence to a healthy plant-based diet was associated with a lower risk of cancer and cardiometabolic multimorbidity in both adults ...