Effects of a Lean Pork Diet on Heart Health in Perimenopausal Women
Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women
This study tests if a diet high in lean pork can improve heart health and reduce hot flashes in overweight and obese women going through menopause compared to a plant-based diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 55 Years |
| Sex | Female |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT06976112 on ClinicalTrials.gov |
What this trial studies
This study investigates how a diet high in fresh lean pork compares to a plant-based diet in improving cardiovascular function and alleviating vasomotor symptoms in overweight and obese perimenopausal women. Participants will follow each diet for four weeks, with a washout period in between, and will undergo various health assessments including blood tests and blood pressure measurements. The goal is to determine the impact of these diets on blood lipids, endothelial function, and other cardiometabolic and inflammatory biomarkers.
Who should consider this trial
Good fit: Ideal candidates are perimenopausal women aged 40 to 55 with a BMI between 28 and 45 who experience severe vasomotor symptoms.
Not a fit: Patients who have undergone a hysterectomy or are using hormone replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve cardiovascular health and reduce menopause-related symptoms in women.
How similar studies have performed: While dietary interventions have been explored in various contexts, this specific comparison of a high pork diet versus a plant-based diet in this demographic is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are female * Are between 40 and 55 years of age * Have a BMI (a number calculated from participant height and weight) between 28 and45 kg/m2 * Are experiencing irregular menstrual cycles but have not gone longer than 12 consecutive months without a period * Are experiencing severe vasomotor (menopause) symptoms * 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 * Have "sugary" hemoglobin called hemoglobin A1c less than or equal to 6.5% * Are willing and able to refrain from using oral mouth wash for the duration of the study because the alcohol in mouth wash inhibits nitrate synthesis * Are willing and able to comply with both the study diets * Are willing to collect blood for future research * Can read, speak, and understand English Exclusion Criteria: * Hysterectomy (partial or full) or oophorectomy * Using hormone replacement therapy use and/or hormonal contraception use 6 months prior to study start * Has systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) * Triglycerides ≥350 mg/dL, low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL, and/or taking a lipid-lowering medication -Diagnosed cardiovascular disease, diabetes (type 1 or 2), or endocrine- related disease (e.g. thyroid, PCOS), unstable gastrointestinal disease, kidney, liver, and/or pancreatic disease * Diagnosed cancer (except skin cancer) in the last 5 years * Taking \>1 blood pressure medication and/or taking 1 blood pressure medication for \<3 months * Taking phosphodiesterase-5 inhibitors, anti-coagulants, corticosteroids, metformin, or insulin. * Weight change ≥6.6 pounds in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study * Current smoking or vaping, Binge and/or heavy drinker * Food allergies or other reasons preventing consumption of study foods with both study diets
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Hannah E Cabre, PhD, RDN — Pennington Biomedical Research Center
- Study coordinator: Hannah E Cabre, PhD, RDN
- Email: hannah.cabre@pbrc.edu
- Phone: 225-763-2826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.