Impact of Lean Pork on Endothelial Function in Perimenopause (NCT06976112) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Lean Pork on Endothelial Function in Perimenopause
United States30 participantsStarted 2025-08-01
Plain-language 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. How does a diet high in pork, compared to a plant-based diet, affects blood lipids, endothelial function, and blood pressure?
2. How does a diet high in pork, compared to a plant-based diet, affects blood nitrate, cardiometabolic biomarkers, inflammatory biomarkers, and vasomotor symptoms?
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.
Who can participate
Age range
40 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Macrovascular Function
Timeframe: From the beginning of the diet period to the end of the diet period at 4 weeks.
2
Change in Microvascular Function
Timeframe: From the beginning of the diet period to the end of the diet period at 4 weeks.
3
Change in Blood Lipids
Timeframe: From the beginning of the diet period to the end of the diet period at 4 weeks.