The Lean Meats Mediterranean Diet Study

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Dietary Modification
• Interventions: Other: Red Meat Restricted; Other: Red Meat Rich

• Registration Number: NCT02573129
• Lead Sponsor: Purdue University

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Red Meat Rich	Red Meat Restricted	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.
Red Meat Restricted	Red Meat Rich	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.
Red Meat Rich	Red Meat Rich	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.
Red Meat Restricted	Red Meat Restricted	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.

Primary Outcome Measures

Name	Time	Method
lipid profile	5 weeks	cholesterol panel
blood pressure	5 weeks	clinical and 24-hr monitoring

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Purdue University - Stone Hall 700 W State St; 🇺🇸 West Lafayette, Indiana, United States