BridgeMD
New treatment option for Cardiovascular Outcome
Official title Impact of Lean Pork on Endothelial Function in Perimenopause
ClinicalTrials.gov ID: NCT06976112
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.