Impact of Lean Pork on Endothelial Function in Perimenopause
This study is looking at how a diet high in lean pork compares to a plant-based diet in perimenopausal women (women experiencing the transition to menopause) who are overweight or obese. Researchers want to see if eating lean pork affects heart and blood vessel health (cardiovascular function) and menopause symptoms like hot flashes (vasomotor symptoms). You may be able to join if you are a woman between 40 and 55 years old, have a BMI (Body Mass Index) between 28 and 45, have irregular periods but haven't gone a full year without one, experience severe menopause symptoms, and exercise less than 3 hours per week. The study will measure changes in blood vessel function and blood fats (lipids) to see if either diet helps. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll about 30 women. Participants will try both the Pork Diet and the Plant Diet for 4 weeks each, with a break in between.
- What's involved
- You would be in the study for 11 to 15 weeks. You will receive 7 days of meals and snacks for 4 weeks for each diet period.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main measurements are taken from the beginning to the end of each 4-week diet period.
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Impact of Lean Pork on Endothelial Function in Perimenopause
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Hannah E Cabre, PhD, RDN · PRINCIPAL_INVESTIGATOR · Pennington Biomedical Research Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Macrovascular FunctionFrom the beginning of the diet period to the end of the diet period at 4 weeks.
Macrovascular function will be measured by endothelial function. Investigators will use brachial artery flow mediated dilation (FMD) using ultrasound. Ultrasound images will be captured (Cardiovascular Suit 4, QUIPU, Pisa, Italy) at three time points 1) end-diastole for each cardiac cycle at baseline (\~30 s), 2) during occlusion (\~5 min), and 3) after occlusion (\~5 min). The shear rate will be calculated for each cardiac cycle as 8 × mean blood velocity/ diameter, and the shear rate area under the curve from cuff release to peak diameter will be quantified as an index of the stimulus for FMD. The FMD values will be expressed as relative (%) changes from baseline to peak diameter and FMD/SRAUC will be corrected for shear rate (FMD/shear rate \[SR\] area under the curve \[AUC\]) in order to account for shear stress inter-individual variability.
- Change in Microvascular FunctionFrom the beginning of the diet period to the end of the diet period at 4 weeks.
Microvascular blood flow will be assessed by near-infrared spectroscopy for oxygenated hemoglobin/myoglobin (O2Hb/O2Mb), deoxygenated hemoglobin/myoglobin (HHb/HMb), total hemoglobin/myoglobin (tHb/tMb), and tissue oxygen saturation (StO2, %)
- Change in Blood LipidsFrom the beginning of the diet period to the end of the diet period at 4 weeks.
A blood lipid panel (total cholesterol, triglycerides, LDL, and HDL) will be performed at each outcome visit.