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NCT06976112
Impact of Lean Pork on Endothelial Function in Perimenopause
Conditions: Cardiovascular Outcome, Overweight and Obese Women, Perimenopausal Women, Vasomotor Symptoms (VMS)
Sex: Female
Ages: 40 Years – 55 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Pennington Biomedical Research Center
Location: Pennington Biomedical Research Center Baton Rouge Louisiana
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.
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 \
Source: ClinicalTrials.gov (NCT06976112). StuddyBuddy aggregates publicly available trial information.