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Impact of Lean Pork on Endothelial Function in Perimenopause

Study acronym: LEAP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description expanded, about 2 words
  2. Minor Start date changed from estimate of Jul 2025 to Aug 1, 2025v3
  3. Notable Start date: May 2025 to Jul 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06976112
Lead Sponsor Pennington Biomedical Research Center
Conditions
(from sponsor)
Cardiovascular Outcome, Overweight and Obese Women, Perimenopausal Women, Vasomotor Symptoms (VMS)
Related terms Overweight
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov