Impact of Lean Pork on Endothelial Function in Perimenopause

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT06976112
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 55 Years
Healthy Volunteers
Accepted

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).
  • 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).

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Pork Diet
    All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork.
  • Experimental: Plant Diet
    All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet.

Primary Outcome Measure

Change in Macrovascular Function [ Time Frame: From the beginning of the diet period to the end of the diet period at 4 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Hannah E Cabre
[email protected]
225-763-2628
Hannah E Cabre, PhD, RDN (PRINCIPAL_INVESTIGATOR)
Leanne M Redman, PhD (SUB_INVESTIGATOR)
Catherine Champagne, PhD (SUB_INVESTIGATOR)

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Pennington Biomedical Research Center· Baton Rouge, LA

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