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Cardiovascular DiseasesNCT02573129

The Lean Meats Mediterranean Diet Study

A study testing Red Meat Restricted and Red Meat Rich in people with Cardiovascular Diseases and Dietary Modification, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Dietary Modification
What is being tested?
Red Meat Restricted and Red Meat Rich
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
May 2015to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • Diabetic
  • Smoker

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Purdue University - Stone Hall 700 W State St

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Red Meat Restricted, Red Meat Rich
Keywords
cardiovascular disease risk, Mediterranean diet, red meat
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Red Meat RestrictedOther

    Also called S44 Mediterranean Diet

    restrict intake of red meat while a Mediterranean diet

  • Red Meat RichOther

    Also called S44 Mediterranean Diet

    Mediterranean diet rich in red meat

Study groups in NCT02573129
Study groupRoleWhat they receive
Red Meat RestrictedExperimentalFollowing 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.
Receives: Other: Red Meat Restricted; Other: Red Meat Rich
Red Meat RichExperimentalFollowing 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.
Receives: Other: Red Meat Restricted; Other: Red Meat Rich

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood pressure

    clinical and 24-hr monitoring

    Measured: 5 weeks

  2. lipid profile

    cholesterol panel

    Measured: 5 weeks

Secondary outcomes (4)

  1. sleep quality

    sleep assessed by using actigraphy / actiwatch

    Measured: 5 weeks

  2. sleep assessment

    Sleep assessed by questionnaires using the Pittsburgh Sleep Quality Index

    Measured: 5 wks

  3. assessment of sleep

    Sleep assessed by questionnaires using the SF-36v2® Health Survey

    Measured: 5 weeks

  4. emotional well-being

    quality of life questionnaires

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573129
Sponsor's protocol ID
PurdueU
Status last verified
Jan 2018
First submitted
28 May 2015
Last updated
12 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37918675

  • 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.

    PubMed 30517731

  • 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.

    PubMed 29901710

Questions about this trial

What is this clinical trial studying?

A study testing Red Meat Restricted and Red Meat Rich in people with Cardiovascular Diseases and Dietary Modification, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood pressure (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573129, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.

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