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| ID | Type | Description | Link |
|---|---|---|---|
| NPB PR-006186 | Other Identifier | National Pork Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pork Diet | Experimental | All participants will receive 7 days x 4 weeks of meals and snacks following a dietary pattern high in pork. |
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| Plant Diet | Experimental | All participants will receive 7 days x 4 weeks of meals and snacks following a plant based diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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, %) | 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. | From the beginning of the diet period to the end of the diet period at 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah E Cabre, PhD, RDN | Contact | 225-763-2826 | hannah.cabre@pbrc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hannah E Cabre, PhD, RDN | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
Individual participant data will be protected under HIPAA
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Single site randomized control trial
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Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.
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| 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). |
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| 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. | 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. | 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. | 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. | 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. | 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. | From the beginning of the diet period to the end of the diet period at 4 weeks. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |