Impact of Lean Pork on Endothelial Function in Perimenopause

Official title

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

Overview

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.

Detailed description

Investigators expect about 30 women will be enrolled in this study. The expected time in this study will be between 11 and 15 weeks.

Participants will consume both of the following diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets when participants will consume their usual diet. The diets will be consumed in random order. Participants will not be able to choose the order. Participants will receive 7 days of meals and snacks for 4 weeks for each diet.

* PORK Diet: A diet following the Dietary Guidelines for Americans with at least 80% of meat consumption being pork per week including tenderloin, loin chops, sirloin roast, flank, rump roast, and small amounts of Canadian bacon and pork sausage. * PLANT Diet: A Lacto-Ovo Vegetarian diet following the Dietary Guidelines for Americans with no more than 21 oz. per week of animal protein including eggs and cheese.

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).

Primary outcome measures

• 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.]

Secondary outcome measures (7)

• Change in Total Score for Hot Flash Related Daily Interference Scale [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]
• Change in Total Score for Menopause Rating Scale [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]
• Change in Total Score for Greene Climacteric Scale [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]
• Change in Blood Nitrates/Nitrites [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]
• Change in Insulin and Blood Glucose [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]
• Change in Inflammation and Immune responses [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]
• Change in Blood Pressure [Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Pennington Biomedical Research Center — Baton Rouge

Identifiers

NCT: NCT06976112 · #PBRC 2024-066 · NPB PR-006186

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗