Impact of Lean Pork on Endothelial Function in Perimenopause

This study is looking at how a diet high in lean pork compares to a plant-based diet in perimenopausal women (women experiencing the transition to menopause) who are overweight or obese. Researchers want to see if eating lean pork affects heart and blood vessel health (cardiovascular function) and menopause symptoms like hot flashes (vasomotor symptoms). You may be able to join if you are a woman between 40 and 55 years old, have a BMI (Body Mass Index) between 28 and 45, have irregular periods but haven't gone a full year without one, experience severe menopause symptoms, and exercise less than 3 hours per week. The study will measure changes in blood vessel function and blood fats (lipids) to see if either diet helps. The current recruitment status is unclear.

Study design
This interventional study plans to enroll about 30 women. Participants will try both the Pork Diet and the Plant Diet for 4 weeks each, with a break in between.
What's involved
You would be in the study for 11 to 15 weeks. You will receive 7 days of meals and snacks for 4 weeks for each diet period.
Compensation
Not stated in the trial record.
Follow-up
The main measurements are taken from the beginning to the end of each 4-week diet period.

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NCT06976112

Impact of Lean Pork on Endothelial Function in Perimenopause

Recruiting
NAAges 40–55InterventionalPrevention
Pennington Biomedical Research Center
~30 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:Pork DietPlant Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Macrovascular Function
Measured over From the beginning of the diet period to the end of the diet period at 4 weeks.
+2 more outcomes measured
Cardiovascular Outcome
Overweight and Obese Women
Perimenopausal Women
Vasomotor Symptoms (VMS)
1 sites across 1 states
Louisiana1
  • Hannah E Cabre, PhD, RDN · PRINCIPAL_INVESTIGATOR · Pennington Biomedical Research Center

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Eligibility criteria

Inclusion

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

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
  • Change in Macrovascular FunctionFrom 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 calculated for each cardiac cycle as 8 × mean blood velocity/ diameter, and the shear rate area under the curve from cuff release to peak diameter will be quantified as an index of the stimulus for FMD. The FMD values will be expressed as relative (%) changes from baseline to peak diameter and FMD/SRAUC will be corrected for shear rate (FMD/shear rate \[SR\] area under the curve \[AUC\]) in order to account for shear stress inter-individual variability.

  • Change in Microvascular FunctionFrom 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 LipidsFrom 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.