Clinical trial NCT06976112: Impact of Lean Pork on Endothelial Function in Perimenopause
Official title: Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Outcome
Overweight and Obese Women
Perimenopausal Women
Vasomotor Symptoms (VMS)
Keywords: Perimenopause
Perimenopausal
Vasomotor Symptoms
VMS
Menopause
Cardiovascular Health
Blood pressure
Pork
Vegetarian
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single site randomized control trial
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Macrovascular Function
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Microvascular Function
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Blood Lipids
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Secondary outcomes:
measure: Change in Total Score for Hot Flash Related Daily Interference Scale
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Total Score for Menopause Rating Scale
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Total Score for Greene Climacteric Scale
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Blood Nitrates/Nitrites
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Insulin and Blood Glucose
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Inflammation and Immune responses
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
measure: Change in Blood Pressure
timeFrame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Hannah E Cabre, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References: