RECRUITING

Impact of Lean Pork on Endothelial Function in Perimenopause

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06976112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are female
  2. * Are between 40 and 55 years of age
  3. * Have a BMI (a number calculated from participant height and weight) between 28 and45 kg/m2
  4. * Are experiencing irregular menstrual cycles but have not gone longer than 12 consecutive months without a period
  5. * Are experiencing severe vasomotor (menopause) symptoms
  6. * Are doing less than 3 hours per week of structured exercise
  7. * Have systolic blood pressure between 120 and 140 mmHg and/or diastolic blood pressure between 80 and 90 mmHg
  8. * Have "sugary" hemoglobin called hemoglobin A1c less than or equal to 6.5%
  9. * 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
  10. * Are willing and able to comply with both the study diets
  11. * Are willing to collect blood for future research
  12. * Can read, speak, and understand English
  1. * Hysterectomy (partial or full) or oophorectomy
  2. * Using hormone replacement therapy use and/or hormonal contraception use 6 months prior to study start
  3. * Has systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
  4. * 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
  5. * Diagnosed cancer (except skin cancer) in the last 5 years
  6. * Taking \>1 blood pressure medication and/or taking 1 blood pressure medication for \<3 months
  7. * Taking phosphodiesterase-5 inhibitors, anti-coagulants, corticosteroids, metformin, or insulin.
  8. * Weight change ≥6.6 pounds in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study
  9. * Current smoking or vaping, Binge and/or heavy drinker
  10. * Food allergies or other reasons preventing consumption of study foods with both study diets

Contacts and Locations

Study Contact

Hannah E Cabre, PhD, RDN
CONTACT
225-763-2826
hannah.cabre@pbrc.edu

Principal Investigator

Hannah E Cabre, PhD, RDN
PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • Hannah E Cabre, PhD, RDN, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-05
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Cardiovascular Outcome
  • Overweight and Obese Women
  • Perimenopausal Women
  • Vasomotor Symptoms (VMS)