An interventional study of Pork Diet and Plant Diet in Cardiovascular Outcome, Overweight and Obese Women and Perimenopausal Women, sponsored by Pennington Biomedical Research Center. Recruiting at 1 site in United States. Open to female participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention
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:
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:
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.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 30 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork.
Behavioral: Pork Diet
All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet.
Behavioral: Plant 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).
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).
Change in Macrovascular Function
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.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Microvascular Function
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, %)
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Blood Lipids
A blood lipid panel (total cholesterol, triglycerides, LDL, and HDL) will be performed at each outcome visit.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Total Score for Hot Flash Related Daily Interference Scale
The Hot Flash Related Daily Interference Scale (HFRDIS) is scored by summing responses to 10 items that assess how hot flashes interfere with daily activities such as work, social interactions, sleep, mood, and concentration. Each item is rated on a scale from 0 (do not interfere) to 10 (completely interfere), resulting in a total score ranging from 0 to 100. Higher scores indicate greater interference from hot flashes, with the scale providing a reliable measure of symptom impact on quality of life.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Total Score for Menopause Rating Scale
The Menopause Rating Scale (MRS) consists of 11 items grouped into three subscales: somatic, psychological, and urogenital symptoms. Each symptom is rated from 0 (no symptoms) to 4 (very severe), with a total score ranging from 0 to 44. Subscale scores are calculated by summing the items within each domain, and higher scores reflect greater severity of menopausal symptoms.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Total Score for Greene Climacteric Scale
The Greene Climacteric Scale includes 21 items measuring psychological, somatic, and vasomotor symptoms, plus one item assessing sexual interest. Each item is rated on a 4-point scale from 0 (not at all) to 3 (extremely), with higher total and subscale scores indicating greater symptom severity. Scores are calculated by summing item responses within each domain and across the entire scale.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Blood Nitrates/Nitrites
Levels of nitrates/nitrites will be assessed from a blood draw.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Insulin and Blood Glucose
Insulin and glucose will be evaluated from a fasting blood draw.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Inflammation and Immune responses
ICAM, VCAM, VEGF, CRP, oxidized LDL, and interleukin-6 will be evaluated from a fasting blood draw.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Change in Blood Pressure
Blood Pressure will be measured using the Welch Allyn CEO297 manual sphygmomanometers.
Time frame: From the beginning of the diet period to the end of the diet period at 4 weeks.
Plan to share: No — Individual participant data will be protected under HIPAA
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 16 months is below that.
Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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