Clinical trial NCT02573129: The Lean Meats Mediterranean Diet Study
Official title: Effects of Incorporating Red Meat Into a Mediterranean-style Dietary Pattern on Cardiometabolic and Emotional Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Dietary Modification
Keywords: cardiovascular disease risk
Mediterranean diet
red meat
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Pork Board
name: National Cattlemen's Beef Association
First posted: 2015-10-09
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: blood pressure
timeFrame: 5 weeks
measure: lipid profile
timeFrame: 5 weeks
Secondary outcomes:
measure: sleep quality
timeFrame: 5 weeks
measure: sleep assessment
timeFrame: 5 wks
measure: assessment of sleep
timeFrame: 5 weeks
measure: emotional well-being
timeFrame: 5 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University - Stone Hall 700 W State St
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayen W Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.