The Lean Meats Mediterranean Diet Study

NCT ID: NCT02573129

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Dietary Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Red Meat Restricted

Intervention Type OTHER

restrict intake of red meat while a Mediterranean diet

Red Meat Rich

Intervention Type OTHER

Mediterranean diet rich in red meat

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.

Group Type EXPERIMENTAL

Red Meat Restricted

Intervention Type OTHER

restrict intake of red meat while a Mediterranean diet

Red Meat Rich

Intervention Type OTHER

Mediterranean diet rich in red meat

Interventions

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Red Meat Restricted

restrict intake of red meat while a Mediterranean diet

Intervention Type OTHER

Red Meat Rich

Mediterranean diet rich in red meat

Intervention Type OTHER

Other Intervention Names

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S44 Mediterranean Diet S44 Mediterranean Diet

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Pork Board

OTHER

Sponsor Role collaborator

National Cattlemen's Beef Association

INDUSTRY

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Wayne Campbell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayen W Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Hill EB, Reisdorph RM, Rasolofomanana-Rajery S, Michel C, Khajeh-Sharafabadi M, Doenges KA, Weaver N, Quinn K, Sutliff AK, Tang M, Borengasser SJ, Frank DN, O'Connor LE, Campbell WW, Krebs NF, Hendricks AE, Reisdorph NA. Salmon Food-Specific Compounds and Their Metabolites Increase in Human Plasma and Are Associated with Cardiometabolic Health Indicators Following a Mediterranean-Style Diet Intervention. J Nutr. 2024 Jan;154(1):26-40. doi: 10.1016/j.tjnut.2023.10.024. Epub 2023 Oct 31.

Reference Type DERIVED
PMID: 37918675 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30517731 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29901710 (View on PubMed)

Other Identifiers

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PurdueU

Identifier Type: -

Identifier Source: org_study_id

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