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Completed

NCT Number: NCT02573129

The Lean Meats Mediterranean Diet Study

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.

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Key information

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Meat Restricted

Other

restrict intake of red meat while a Mediterranean diet

Other names: S44 Mediterranean Diet

Red Meat Rich

Other

Mediterranean diet rich in red meat

Other names: S44 Mediterranean Diet

Primary outcomes

  1. blood pressure

    Time frame: 5 weeks

    clinical and 24-hr monitoring

  2. lipid profile

    Time frame: 5 weeks

    cholesterol panel

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff
  • National Pork Board

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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