Overview

This trial is active, not recruiting.

Conditions cardiovascular diseases, dietary modification
Treatments red meat restricted, red meat rich
Sponsor Purdue University
Collaborator National Pork Board
Start date May 2015
End date June 2017
Trial size 45 participants
Trial identifier NCT02573129, PurdueU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
red meat restricted S44 Mediterranean Diet
restrict intake of red meat while a Mediterranean diet
red meat rich S44 Mediterranean Diet
Mediterranean diet rich in red meat
(Experimental)
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.
red meat restricted S44 Mediterranean Diet
restrict intake of red meat while a Mediterranean diet
red meat rich S44 Mediterranean Diet
Mediterranean diet rich in red meat

Primary Outcomes

Measure
blood pressure
time frame: 5 weeks
lipid profile
time frame: 5 weeks

Secondary Outcomes

Measure
sleep quality
time frame: 5 weeks
sleep assessment
time frame: 5 wks
assessment of sleep
time frame: 5 weeks
emotional well-being
time frame: 5 weeks

Eligibility Criteria

Male or female participants from 30 years up to 69 years old.

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

Additional Information

Official title Effects of Incorporating Red Meat Into a Mediterranean-style Dietary Pattern on Cardiometabolic and Emotional Well-being
Principal investigator Wayen W Campbell, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Purdue University.