Actively Recruiting

Phase Not Applicable
Age: 40Years - 55Years
FEMALE
Healthy Volunteers
ID06976112

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

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

30

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how a diet high in fresh lean pork compares to a plant-based diet in affecting cardiovascular health and menopause symptoms in perimenopausal women who are overweight or obese. The study focuses on how these diets impact blood lipids, blood pressure, endothelial function, and vasomotor symptoms during perimenopause. About 30 women aged 40 to 55 years will participate in this study conducted by the Pennington Biomedical Research Center. Participants will follow two different diets in a random order: one diet rich in pork making up at least 80% of meat consumed and another plant-based Lacto-Ovo Vegetarian diet with limited animal protein. Each diet will be consumed for 4 weeks with a washout period of 2 to 6 weeks where participants return to their usual diet. They will receive weekly meal packages containing 7 days of meals and snacks during each diet period. During the study, participants will visit the clinic five times for assessments including weight, body composition, blood pressure, pulse, and ultrasound to measure endothelial function. Blood samples, physical activity monitoring, and questionnaires about menopause symptoms will also be collected. Researchers will measure changes in vascular function, blood lipids, blood pressure, and menopause-related symptoms over the 4-week diet periods. The entire study duration is expected to be 11 to 15 weeks.

CONDITIONS

Brief 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
  • Aged between 40 and 55 years
  • Body Mass Index (BMI) between 28 and 45 kg/m2
  • Experiencing irregular menstrual cycles but not more than 12 months without a period
  • Experiencing severe vasomotor (menopause) symptoms
  • Doing less than 3 hours of structured exercise per week
  • 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 avoid 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 before the 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 taking lipid-lowering medication
  • Diagnosed cardiovascular disease, diabetes (type 1 or 2), endocrine-related diseases such as thyroid disorders or PCOS, unstable gastrointestinal disease, or kidney, liver, or pancreatic disease
  • Cancer diagnosis (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 the past 3 months, actively trying to lose weight, or unwilling to maintain current weight during the study
  • Current smoking or vaping
  • Binge or heavy alcohol drinking
  • Food allergies or other reasons preventing consumption of study foods in both diets

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 11 to 15 weeks

Participants will follow two different diets in random order: a Pork Diet and a Plant Diet, each consumed for 4 weeks with a washout period of 2 to 6 weeks between diets where participants consume their usual diet.

Regular visits for diet monitoring and assessments

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

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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