What this study is
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.
What's being tested
- Pork Diet
Intervention · BEHAVIORAL
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
Intervention · BEHAVIORAL
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).
Study details
- Official title
- Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women
- Sponsor
- Pennington Biomedical Research Center
- Conditions
- Cardiovascular Outcome · Overweight and Obese Women · Perimenopausal Women · Vasomotor Symptoms (VMS)
- Enrolling
- 30 people
- Starts
- 2025-08-01
- Est. completion
- 2027-05
- Design
- Double-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 55 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify 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
- 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
You 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPennington Biomedical Research Center
Baton Rouge, Louisiana, United States
- Hannah E Cabre · Contact225-763-2628hannah.cabre@pbrc.edu
- Hannah E Cabre, PhD, RDN · Principal investigator
- Leanne M Redman, PhD · Sub-investigator
- Catherine Champagne, PhD · Sub-investigator
Recruiting
Study team
Sponsor
Pennington Biomedical Research Center
Study ID #PBRC 2024-066
Principal investigator
Hannah E Cabre, PhD, RDN
Pennington Biomedical Research Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.