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Recruiting NCT06976112

NCT06976112 Impact of Lean Pork on Endothelial Function in Perimenopause

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Clinical Trial Summary
NCT ID NCT06976112
Status Recruiting
Phase
Sponsor Pennington Biomedical Research Center
Condition Cardiovascular Outcome
Study Type INTERVENTIONAL
Enrollment 30 participants
Start Date 2025-08-01
Primary Completion 2026-12-31

Eligibility & Interventions

Sex Female only
Min Age 40 Years
Max Age 55 Years
Study Type INTERVENTIONAL
Interventions
Pork DietPlant Diet

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Hannah E Cabre, PhD, RDN

✉ hannah.cabre@pbrc.edu

📞 225-763-2826

Principal Investigator

Hannah E Cabre, PhD, RDN

PRINCIPAL INVESTIGATOR

Pennington Biomedical Research Center

Frequently Asked Questions

Who can join the NCT06976112 clinical trial?

This trial is open to female participants only, aged 40 Years or older, up to 55 Years, studying Cardiovascular Outcome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06976112 currently recruiting?

Yes, NCT06976112 is actively recruiting participants. Contact the research team at hannah.cabre@pbrc.edu for enrollment information.

Where is the NCT06976112 trial being conducted?

This trial is being conducted at Baton Rouge, United States.

Who is sponsoring the NCT06976112 clinical trial?

NCT06976112 is sponsored by Pennington Biomedical Research Center. The principal investigator is Hannah E Cabre, PhD, RDN at Pennington Biomedical Research Center. The trial plans to enroll 30 participants.

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