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The Lean Meats Mediterranean Diet Study

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

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 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

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573129


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