Impact of Lean Pork on Endothelial Function in Perimenopause
- Conditions
- Cardiovascular OutcomePerimenopausal WomenVasomotor Symptoms (VMS)Overweight and Obese Women
- Registration Number
- NCT06976112
- Lead Sponsor
- Pennington Biomedical Research Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in Macrovascular Function From the beginning of the diet period to the end of the diet period at 4 weeks. Macrovascular function will be measured by endothelial function. Investigators will use brachial artery flow mediated dilation (FMD) using ultrasound. Ultrasound images will be captured (Cardiovascular Suit 4, QUIPU, Pisa, Italy) at three time points 1) end-diastole for each cardiac cycle at baseline (\~30 s), 2) during occlusion (\~5 min), and 3) after occlusion (\~5 min). The shear rate will be calculated for each cardiac cycle as 8 × mean blood velocity/ diameter, and the shear rate area under the curve from cuff release to peak diameter will be quantified as an index of the stimulus for FMD. The FMD values will be expressed as relative (%) changes from baseline to peak diameter and FMD/SRAUC will be corrected for shear rate (FMD/shear rate \[SR\] area under the curve \[AUC\]) in order to account for shear stress inter-individual variability.
Change in Microvascular Function From the beginning of the diet period to the end of the diet period at 4 weeks. Microvascular blood flow will be assessed by near-infrared spectroscopy for oxygenated hemoglobin/myoglobin (O2Hb/O2Mb), deoxygenated hemoglobin/myoglobin (HHb/HMb), total hemoglobin/myoglobin (tHb/tMb), and tissue oxygen saturation (StO2, %)
Change in Blood Lipids From the beginning of the diet period to the end of the diet period at 4 weeks. A blood lipid panel (total cholesterol, triglycerides, LDL, and HDL) will be performed at each outcome visit.
- Secondary Outcome Measures
Name Time Method Change in Total Score for Hot Flash Related Daily Interference Scale From the beginning of the diet period to the end of the diet period at 4 weeks. The Hot Flash Related Daily Interference Scale (HFRDIS) is scored by summing responses to 10 items that assess how hot flashes interfere with daily activities such as work, social interactions, sleep, mood, and concentration. Each item is rated on a scale from 0 (do not interfere) to 10 (completely interfere), resulting in a total score ranging from 0 to 100. Higher scores indicate greater interference from hot flashes, with the scale providing a reliable measure of symptom impact on quality of life.
Change in Total Score for Menopause Rating Scale From the beginning of the diet period to the end of the diet period at 4 weeks. The Menopause Rating Scale (MRS) consists of 11 items grouped into three subscales: somatic, psychological, and urogenital symptoms. Each symptom is rated from 0 (no symptoms) to 4 (very severe), with a total score ranging from 0 to 44. Subscale scores are calculated by summing the items within each domain, and higher scores reflect greater severity of menopausal symptoms.
Change in Total Score for Greene Climacteric Scale From the beginning of the diet period to the end of the diet period at 4 weeks. The Greene Climacteric Scale includes 21 items measuring psychological, somatic, and vasomotor symptoms, plus one item assessing sexual interest. Each item is rated on a 4-point scale from 0 (not at all) to 3 (extremely), with higher total and subscale scores indicating greater symptom severity. Scores are calculated by summing item responses within each domain and across the entire scale.
Change in Blood Nitrates/Nitrites From the beginning of the diet period to the end of the diet period at 4 weeks. Levels of nitrates/nitrites will be assessed from a blood draw.
Change in Insulin and Blood Glucose From the beginning of the diet period to the end of the diet period at 4 weeks. Insulin and glucose will be evaluated from a fasting blood draw.
Change in Inflammation and Immune responses From the beginning of the diet period to the end of the diet period at 4 weeks. ICAM, VCAM, VEGF, CRP, oxidized LDL, and interleukin-6 will be evaluated from a fasting blood draw.
Change in Blood Pressure From the beginning of the diet period to the end of the diet period at 4 weeks. Blood Pressure will be measured using the Welch Allyn CEO297 manual sphygmomanometers.
Trial Locations
- Locations (1)
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States