Impact of Lean Pork on Endothelial Function in Perimenopause

NCT06976112 | Recruiting DMC

• 2 other identifiers: #PBRC 2024-066NPB PR-006186
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in Macrovascular Function

  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.

  From the beginning of the diet period to the end of the diet period at 4 weeks.

• Change in Microvascular Function

  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, %)

  From the beginning of the diet period to the end of the diet period at 4 weeks.

• Change in Blood Lipids

  A blood lipid panel (total cholesterol, triglycerides, LDL, and HDL) will be performed at each outcome visit.

  From the beginning of the diet period to the end of the diet period at 4 weeks.

Secondary Outcomes (7)

• 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.

• 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.

• 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.

• Change in Blood Nitrates/Nitrites

  From the beginning of the diet period to the end of the diet period at 4 weeks.

• Change in Insulin and Blood Glucose

  From the beginning of the diet period to the end of the diet period at 4 weeks.

Study Arms (2)

Pork Diet

EXPERIMENTAL

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

Behavioral: Pork Diet

Plant Diet

EXPERIMENTAL

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

Behavioral: Plant Diet

Interventions

Pork Diet 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).

Pork Diet

Plant Diet 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).

Plant Diet

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: * Cisgender people identify with the gender that aligns with the sex they were assigned at birth. * Nonbinary people do not identify exclusively as a man or boy or as a woman or girl.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Conditions

Overweight

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hannah E Cabre, PhD, RDN

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah E Cabre, PhD, RDN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site randomized control trial

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 16, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)