Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06976112

Impact of Lean Pork on Endothelial Function in Perimenopause

Sponsor: Pennington Biomedical Research Center

View on ClinicalTrials.gov

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.

Official title: Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women

Key Details

Gender

FEMALE

Age Range

40 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-01

Completion Date

2027-05

Last Updated

2025-11-28

Healthy Volunteers

Yes

Conditions

Cardiovascular Outcome Overweight and Obese Women Perimenopausal Women Vasomotor Symptoms (VMS)

Interventions

BEHAVIORAL

Pork Diet

The diet will follow the Dietary Guidelines for Americans with 80% of the meat consumption per week being pork. Other animal protein (e.g., turkey, chicken, beef) will be minimized in the dietary plans (≤ 20%) so lean and processed pork are the primary protein source consumed. Within each day, \~80% of the daily pork intake will be fresh, unprocessed lean cuts (e.g., tenderloin, loin chops, sirloin roast, flank, and rump roast) and \~20% will be cured sources (e.g., Canadian bacon, pork sausage).

BEHAVIORAL

Plant Diet

The diet will be a Lacto-Ovo Vegetarian Diet following the Dietary Guidelines for Americans with no more than 21 oz per week of animal protein (e.g., eggs, cheese).

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

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States