The Lean Meats Mediterranean Diet Study

Study Overview
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Brief Summary
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The purpose of the proposed research study is to assess the effects of including greater amounts of minimally processed red meat (lean pork and beef) into a Mediterranean Diet on cardiometabolic and emotional well-being.

Detailed Description
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All subjects will complete an 18-wk randomized crossover study. Following a 2-wk baseline testing period to assess cardiometabolic and emotional well-being and habitual diet, subjects will consume a Mediterranean-style, weight-maintenance diet that is either restricted or rich in lean, minimally processed red meat for 5 weeks. Following a 4-wk washout period and second 2-wk baseline testing, subjects will consume the Mediterranean Diet with the alternate predominant animal protein sources for 5 weeks. Cardiometabolic and emotional well-being will be assessed during baseline and post periods.

Official Title
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Effects of Incorporating Red Meat Into a Mediterranean-style Dietary Pattern on Cardiometabolic and Emotional Well-being

Conditions
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Cardiovascular Diseases, Dietary Modification

Intervention / Treatment
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* Other: Red Meat Restricted
* Other: Red Meat Rich


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 30-69 years old BMI 25-37 kg/m2 Total cholesterol <240 mg/dL Low-density lipoprotein <160 mg/dL Triglycerides <400 mg/dL Fasting glucose <110 mg/dL Systolic blood pressure <160 mmHg Diastolic blood pressure <100 mmHg Body weight <300 lb Weight stable for 3 months prior (±10 lb) Stable physical activity regimen 3 months prior ≤3 h/wk of moderate or high intensity exercise resistance or aerobic training Medication use stable for 6 months prior. Exclusion Criteria: Diabetic Smoker

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red Meat Restricted<br>Following a 2-wk baseline testing period to assess cardiometabolic and emotional well-being and habitual diet, subjects will consume a Mediterranean-style, weight-maintenance diet that is restricted in lean, minimally processed red meat for 5 weeks. | Other: Red Meat Restricted<br>* restrict intake of red meat while a Mediterranean diet<br>* Other names: S44 Mediterranean Diet;Other: Red Meat Rich<br>* Mediterranean diet rich in red meat<br>* Other names: S44 Mediterranean Diet;|
| Experimental: Red Meat Rich<br>Following a 4-wk wash out period and a 2-wk baseline testing period to assess cardiometabolic and emotional well-being and habitual diet, subjects will consume a Mediterranean-style, weight-maintenance diet that is rich in lean, minimally processed red meat for 5 weeks. | Other: Red Meat Restricted<br>* restrict intake of red meat while a Mediterranean diet<br>* Other names: S44 Mediterranean Diet;Other: Red Meat Rich<br>* Mediterranean diet rich in red meat<br>* Other names: S44 Mediterranean Diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | clinical and 24-hr monitoring | 5 weeks | 
| lipid profile | cholesterol panel | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality | sleep assessed by using actigraphy / actiwatch | 5 weeks | 
| sleep assessment | Sleep assessed by questionnaires using the Pittsburgh Sleep Quality Index | 5 wks | 
| assessment of sleep | Sleep assessed by questionnaires using the SF-36v2® Health Survey | 5 weeks | 
| emotional well-being | quality of life questionnaires | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease risk, Mediterranean diet, red meat