Recruiting

Pork vs. Plant-Based

Sponsor:

Pennington Biomedical Research Center

Code:

NCT06976112

Conditions

Cardiovascular Outcome

Overweight and Obese Women

Perimenopausal Women

Vasomotor Symptoms (VMS)

Eligibility Criteria

Sex: Female

Age: 40 - 55

Healthy Volunteers: Accepted

Interventions

Pork Diet

Plant Diet

Study Details

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.

Conditions

Cardiovascular Outcome

Overweight and Obese Women

Perimenopausal Women

Vasomotor Symptoms (VMS)

Study ID

NCT06976112

Start date

Aug 1, 2025

Status verified date

May, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Pork Diet

All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork.

experimental: Plant Diet

All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet.

Interventions

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).

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).

Primary outcome measure

  • Change in Macrovascular Function [ Time Frame: From the beginning of the diet period to the end of the diet period at 4 weeks. ]
  • Change in Microvascular Function [ Time Frame: From the beginning of the diet period to the end of the diet period at 4 weeks. ]
  • Change in Blood Lipids [ Time Frame: From the beginning of the diet period to the end of the diet period at 4 weeks. ]

Central Contacts and Locations

Central contacts

Hannah E Cabre, PhD, RDN

225-763-2826hannah.cabre@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Hannah E Cabre

225-763-2628hannah.cabre@pbrc.edu

Principal Investigator:

Hannah E Cabre, PhD, RDN

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Nov 28, 2025

Last verified

May, 2025

Keywords

  • Perimenopause
  • Perimenopausal
  • Vasomotor Symptoms
  • VMS
  • Menopause
  • Cardiovascular Health
  • Blood pressure
  • Pork
  • Vegetarian

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2025-11-28.