The Lean Meats Mediterranean Diet Study

Purdue University41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases Dietary Modification

Interventions

Red Meat RestrictedOTHER

restrict intake of red meat while a Mediterranean diet

Red Meat RichOTHER

Mediterranean diet rich in red meat

Eligibility

Sex: ALLMin age: 30 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, United States

Outcomes

Primary Outcomes

blood pressure

clinical and 24-hr monitoring

Time frame: 5 weeks

lipid profile

cholesterol panel

Time frame: 5 weeks

Secondary Outcomes

sleep quality

sleep assessed by using actigraphy / actiwatch

Time frame: 5 weeks

sleep assessment

Sleep assessed by questionnaires using the Pittsburgh Sleep Quality Index

Time frame: 5 wks

assessment of sleep

Sleep assessed by questionnaires using the SF-36v2® Health Survey

Time frame: 5 weeks

emotional well-being

quality of life questionnaires

Time frame: 5 weeks

Data from ClinicalTrials.gov

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