NCT02573129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

May 28, 2015

Last Update Submit

January 9, 2018

Conditions

Cardiovascular DiseasesDietary Modification

Keywords

cardiovascular disease riskMediterranean dietred meat

Outcome Measures

Primary Outcomes (2)

  • blood pressure

    clinical and 24-hr monitoring

    5 weeks

  • lipid profile

    cholesterol panel

    5 weeks

Secondary Outcomes (4)

  • sleep quality

    5 weeks

  • sleep assessment

    5 wks

  • assessment of sleep

    5 weeks

  • emotional well-being

    5 weeks

Study Arms (2)

Red Meat Restricted

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.

Other: Red Meat RestrictedOther: Red Meat Rich

Red Meat Rich

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.

Other: Red Meat RestrictedOther: Red Meat Rich

Interventions

Red Meat RestrictedOTHER

restrict intake of red meat while a Mediterranean diet

Also known as: S44 Mediterranean Diet
Red Meat RestrictedRed Meat Rich
Red Meat RichOTHER

Mediterranean diet rich in red meat

Also known as: S44 Mediterranean Diet
Red Meat RestrictedRed Meat Rich

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diabetic
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University - Stone Hall 700 W State St

West Lafayette, Indiana, 47907, United States

Location

Related Publications (3)

  • 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.

    PMID: 37918675DERIVED

  • 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.

    PMID: 30517731DERIVED

  • 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.

    PMID: 29901710DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Wayen W Campbell, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2015

First Posted

October 9, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

US(1)