Actively Recruiting

Phase Not Applicable
Age: 40Years - 55Years
FEMALE
Healthy Volunteers
NCT06976112

Impact of Lean Pork on Endothelial Function in Perimenopause

Led by Pennington Biomedical Research Center · Updated on 2025-11-28

30

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Impact of Lean Pork on Endothelial Function in Perimenopause

Who Can Participate

Age: 40Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants
  • Age between 40 and 55 years
  • Body Mass Index (BMI) between 28 and 45 kg/m2
  • Experiencing irregular menstrual cycles but not more than 12 consecutive months without a period
  • Experiencing severe vasomotor (menopause) symptoms
  • Doing less than 3 hours per week of structured exercise
  • Systolic blood pressure between 120 and 140 mmHg and/or diastolic blood pressure between 80 and 90 mmHg
  • Hemoglobin A1c less than or equal to 6.5%
  • Willing and able to refrain from using oral mouthwash during the study
  • Willing and able to follow both study diets
  • Willing to provide blood samples for future research
  • Able to read, speak, and understand English
Not Eligible

You will not qualify if you...

  • History of hysterectomy (partial or full) or oophorectomy
  • Use of hormone replacement therapy or hormonal contraception within 6 months prior to study
  • Systolic blood pressure 140 mmHg or higher and/or diastolic blood pressure 90 mmHg or higher
  • Triglycerides 350 mg/dL or higher, LDL cholesterol 190 mg/dL or higher, or currently taking lipid-lowering medication
  • Diagnosed with cardiovascular disease, diabetes (type 1 or 2), endocrine-related diseases (e.g., thyroid, PCOS), unstable gastrointestinal disease, or kidney, liver, or pancreatic disease
  • Diagnosed with cancer (except skin cancer) within the last 5 years
  • Taking more than one blood pressure medication or taking one blood pressure medication for less than 3 months
  • Taking phosphodiesterase-5 inhibitors, anti-coagulants, corticosteroids, metformin, or insulin
  • Weight change of 6.6 pounds or more in past 3 months, actively trying to lose weight, or unwilling to maintain stable weight during study
  • Current smoking or vaping
  • Binge or heavy alcohol drinking
  • Food allergies or other reasons preventing consumption of study foods in both diets

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Trial Site Locations

Total: 1 location

1

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Actively Recruiting

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Research Team

H

Hannah E Cabre, PhD, RDN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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