The Lean Meats Mediterranean Diet Study

• ClinicalTrials.gov Identifier: NCT02573129
• Recruitment Status: Completed
• First Posted: October 9, 2015
• Last Update Posted: January 12, 2018
• Sponsor: Purdue University
• Collaborators: National Pork Board; National Cattlemen's Beef Association
• Information provided by (Responsible Party): Wayne Campbell, Purdue University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Dietary Modification	Other: Red Meat Restricted; Other: Red Meat Rich	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effects of Incorporating Red Meat Into a Mediterranean-style Dietary Pattern on Cardiometabolic and Emotional Well-being
• Study Start Date: May 2015
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

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 Name: S44 Mediterranean Diet; Other: Red Meat Rich; Mediterranean diet rich in red meat; Other Name: 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 Name: S44 Mediterranean Diet; Other: Red Meat Rich; Mediterranean diet rich in red meat; Other Name: S44 Mediterranean Diet

Outcome Measures

Primary Outcome Measures :

1. blood pressure [ Time Frame: 5 weeks ]
   clinical and 24-hr monitoring
2. lipid profile [ Time Frame: 5 weeks ]
   cholesterol panel

Secondary Outcome Measures :

1. sleep quality [ Time Frame: 5 weeks ]
   sleep assessed by using actigraphy / actiwatch
2. sleep assessment [ Time Frame: 5 wks ]
   Sleep assessed by questionnaires using the Pittsburgh Sleep Quality Index
3. assessment of sleep [ Time Frame: 5 weeks ]
   Sleep assessed by questionnaires using the SF-36v2® Health Survey
4. emotional well-being [ Time Frame: 5 weeks ]
   quality of life questionnaires

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Indiana

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, United States, 47907

Sponsors and Collaborators

Purdue University

National Pork Board

National Cattlemen's Beef Association

Investigators

• Principal Investigator: Wayen W Campbell, PhD; Purdue University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wayne Campbell, Professor, Purdue University
• ClinicalTrials.gov Identifier: NCT02573129
• Other Study ID Numbers: PurdueU
• First Posted: October 9, 2015
• Last Update Posted: January 12, 2018
• Last Verified: January 2018

Keywords provided by Wayne Campbell, Purdue University:

cardiovascular disease risk; Mediterranean diet; red meat

Additional relevant MeSH terms:

Cardiovascular Diseases