Impact of Lean Pork on Endothelial Function in Perimenopause

What this trial studies

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.

Conditions in scope

• Cardiovascular Outcome
• Overweight and Obese Women
• Perimenopausal Women
• Vasomotor Symptoms (VMS)

Interventions

• Pork Diet (Behavioral) — The diet will follow the Dietary Guidelines for Americans with 80% of the meat consumption per week being pork. Other animal protein (e.g., turkey, chicken, beef) will be minimized in the dietary plans (≤ 20%) so lean and processed pork…
• Plant Diet (Behavioral) — The diet will be a Lacto-Ovo Vegetarian Diet following the Dietary Guidelines for Americans with no more than 21 oz per week of animal protein (e.g., eggs, cheese).

Who can join

Women only · Ages 40 Years to 55 Years · Accepts healthy volunteers.

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%

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-08-01
• Primary completion: 2026-12-31
• Last update posted: 2025-11-28
• First posted: 2025-05-16

Sponsor & contact

Lead sponsor: Pennington Biomedical Research Center (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in Macrovascular Function (From the beginning of the diet period to the end of the diet period at 4 weeks.)
  Macrovascular function will be measured by endothelial function. Investigators will use brachial artery flow mediated dilation (FMD) using ultrasound. Ultrasound images will be captured (Cardiovascular Suit 4, QUIPU, Pisa, Italy) at three time points 1) end-diastole for each cardiac cycle at baseline (\~30 s), 2) during occlusion (\~5 min), and 3) after occlusion (\~5 min). The shear rate will be…
• Change in Microvascular Function (From the beginning of the diet period to the end of the diet period at 4 weeks.)
  Microvascular blood flow will be assessed by near-infrared spectroscopy for oxygenated hemoglobin/myoglobin (O2Hb/O2Mb), deoxygenated hemoglobin/myoglobin (HHb/HMb), total hemoglobin/myoglobin (tHb/tMb), and tissue oxygen saturation (StO2, %)
• Change in Blood Lipids (From the beginning of the diet period to the end of the diet period at 4 weeks.)
  A blood lipid panel (total cholesterol, triglycerides, LDL, and HDL) will be performed at each outcome visit.

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