Status:
RECRUITING
Impact of Lean Pork on Endothelial Function in Perimenopause
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Cardiovascular Outcome
Overweight and Obese Women
Eligibility:
FEMALE
40-55 years
Phase:
NA
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 overwe...
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 ...
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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06976112
Start Date
August 1 2025
End Date
May 1 2027
Last Update
November 28 2025
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808