The Lean Meats Mediterranean Diet Study

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573129
• Other study ID #: PurdueU
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: January 9, 2018
• Start date: May 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dietary Modification

Intervention

Other:
• Red Meat Restricted
restrict intake of red meat while a Mediterranean diet
• Red Meat Rich
Mediterranean diet rich in red meat

Locations

Country	Name	City	State
United States	Purdue University - Stone Hall 700 W State St	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Purdue University	National Cattlemen's Beef Association, National Pork Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure	clinical and 24-hr monitoring	5 weeks
Primary	lipid profile	cholesterol panel	5 weeks
Secondary	sleep quality	sleep assessed by using actigraphy / actiwatch	5 weeks
Secondary	sleep assessment	Sleep assessed by questionnaires using the Pittsburgh Sleep Quality Index	5 wks
Secondary	assessment of sleep	Sleep assessed by questionnaires using the SF-36v2® Health Survey	5 weeks
Secondary	emotional well-being	quality of life questionnaires	5 weeks