The Lean Meats Mediterranean Diet Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Dietary Modification
• Intervention / Treatment: Other: Red Meat Restricted; Other: Red Meat Rich

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University - Stone Hall 700 W State St

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Red Meat Restricted; restrict intake of red meat while a Mediterranean diet; Other Names: S44 Mediterranean Diet; Other: Red Meat Rich; Mediterranean diet rich in red meat; Other Names: S44 Mediterranean Diet
Experimental: 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.	Other: Red Meat Restricted; restrict intake of red meat while a Mediterranean diet; Other Names: S44 Mediterranean Diet; Other: Red Meat Rich; Mediterranean diet rich in red meat; Other Names: S44 Mediterranean Diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: National Cattlemen's Beef Association; National Pork Board
• Investigators: Principal Investigator: Wayen W Campbell, PhD, Purdue University

Publications and helpful links

General Publications

• O'Connor LE, Biberstine SL, Paddon-Jones D, Schwichtenberg AJ, Campbell WW. Adopting a Mediterranean-Style Eating Pattern with Different Amounts of Lean Unprocessed Red Meat Does Not Influence Short-Term Subjective Personal Well-Being in Adults with Overweight or Obesity. J Nutr. 2018 Dec 1;148(12):1917-1923. doi: 10.1093/jn/nxy235.
• O'Connor LE, Paddon-Jones D, Wright AJ, Campbell WW. A Mediterranean-style eating pattern with lean, unprocessed red meat has cardiometabolic benefits for adults who are overweight or obese in a randomized, crossover, controlled feeding trial. Am J Clin Nutr. 2018 Jul 1;108(1):33-40. doi: 10.1093/ajcn/nqy075.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: cardiovascular disease risk; Mediterranean diet; red meat
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PurdueU