Cardiovascular OutcomeLEAPNCT06976112
Impact of Lean Pork on Endothelial Function in Perimenopause
A study testing Pork Diet and Plant Diet in people with Cardiovascular Outcome and Overweight and Obese Women, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Outcome, Overweight and Obese Women, Perimenopausal Women
- What is being tested?
- Pork Diet and Plant Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Hannah E Cabre, 225-763-2628, hannah.cabre@pbrc.edu
Hannah E Cabre, PhD, RDN
About this study
Official title: Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women
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:
- How does a diet high in pork, compared to a plant-based diet, affects blood lipids, endothelial function, and blood pressure?
- How does a diet high in pork, compared to a plant-based diet, affects blood nitrate, cardiometabolic biomarkers, inflammatory biomarkers, and vasomotor symptoms?
Read more
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.
Read the detailed description
Investigators expect about 30 women will be enrolled in this study. The expected time in this study will be between 11 and 15 weeks.
Participants will consume both of the following diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets when participants will consume their usual diet. The diets will be consumed in random order. Participants will not be able to choose the order. Participants will receive 7 days of meals and snacks for 4 weeks for each diet.
- PORK Diet: A diet following the Dietary Guidelines for Americans with at least 80% of meat consumption being pork per week including tenderloin, loin chops, sirloin roast, flank, rump roast, and small amounts of Canadian bacon and pork sausage.
- PLANT Diet: A Lacto-Ovo Vegetarian diet following the Dietary Guidelines for Americans with no more than 21 oz. per week of animal protein including eggs and cheese.
- Conditions
- Cardiovascular Outcome, Overweight and Obese Women, Perimenopausal Women, Vasomotor Symptoms (VMS)
- Being tested
- Pork Diet, Plant Diet
- Keywords
- Perimenopause, Perimenopausal, Vasomotor Symptoms, VMS, Menopause, Cardiovascular Health, Blood pressure, Pork, Vegetarian
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pork DietBehavioural
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 are the primary protein source consumed. Within each day, ~80% of the daily pork intake will be fresh, unprocessed lean cuts (e.g., tenderloin, loin chops, sirloin roast, flank, and rump roast) and ~20% will be cured sources (e.g., Canadian bacon, pork sausage).
Plant DietBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Pork Diet | Experimental | All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork. Receives: Behavioral: Pork Diet |
| Plant Diet | Experimental | All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet. Receives: Behavioral: Plant Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Macrovascular Function
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.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Microvascular Function
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, %)
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Blood Lipids
A blood lipid panel (total cholesterol, triglycerides, LDL, and HDL) will be performed at each outcome visit.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Secondary outcomes (7)
Change in Total Score for Hot Flash Related Daily Interference Scale
The Hot Flash Related Daily Interference Scale (HFRDIS) is scored by summing responses to 10 items that assess how hot flashes interfere with daily activities such as work, social interactions, sleep, mood, and concentration. Each item is rated on a scale from 0 (do not interfere) to 10 (completely interfere), resulting in a total score ranging from 0 to 100. Higher scores indicate greater interference from hot flashes, with the scale providing a reliable measure of symptom impact on quality of life.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Total Score for Menopause Rating Scale
The Menopause Rating Scale (MRS) consists of 11 items grouped into three subscales: somatic, psychological, and urogenital symptoms. Each symptom is rated from 0 (no symptoms) to 4 (very severe), with a total score ranging from 0 to 44. Subscale scores are calculated by summing the items within each domain, and higher scores reflect greater severity of menopausal symptoms.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Total Score for Greene Climacteric Scale
The Greene Climacteric Scale includes 21 items measuring psychological, somatic, and vasomotor symptoms, plus one item assessing sexual interest. Each item is rated on a 4-point scale from 0 (not at all) to 3 (extremely), with higher total and subscale scores indicating greater symptom severity. Scores are calculated by summing item responses within each domain and across the entire scale.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Blood Nitrates/Nitrites
Levels of nitrates/nitrites will be assessed from a blood draw.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Insulin and Blood Glucose
Insulin and glucose will be evaluated from a fasting blood draw.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Inflammation and Immune responses
ICAM, VCAM, VEGF, CRP, oxidized LDL, and interleukin-6 will be evaluated from a fasting blood draw.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Blood Pressure
Blood Pressure will be measured using the Welch Allyn CEO297 manual sphygmomanometers.
Measured: From the beginning of the diet period to the end of the diet period at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single site randomized control trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah E Cabre, PhD, RDN, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976112
- Sponsor's protocol ID
- #PBRC 2024-066
- Other IDs
- NPB PR-006186
- Acronym
- LEAP
- Status last verified
- May 2026
- First submitted
- 23 Apr 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be protected under HIPAA