NCT06976112

Impact of Lean Pork on Endothelial Function in Perimenopause

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

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: 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.

Detailed description

Investigators expect about 30 women will be enrolled in this study. The expected time in this study will be between 11 and 15 weeks. Participants will consume both of the following diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets when participants will consume their usual diet. The diets will be consumed in random order. Participants will not be able to choose the order. Participants will receive 7 days of meals and snacks for 4 weeks for each diet. * PORK Diet: A diet following the Dietary Guidelines for Americans with at least 80% of meat consumption being pork per week including tenderloin, loin chops, sirloin roast, flank, rump roast, and small amounts of Canadian bacon and pork sausage. * PLANT Diet: A Lacto-Ovo Vegetarian diet following the Dietary Guidelines for Americans with no more than 21 oz. per week of animal protein including eggs and cheese.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Pork Diet	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).
BEHAVIORAL	Plant Diet	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).

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-31
• Completion: 2027-05-01
• First posted: 2025-05-16
• Last updated: 2025-11-28

Locations

1 site across 1 country: United States