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The Mediterranean Full-Fat Dairy Study (MFFD)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781675
First Posted: May 24, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
  Purpose
A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts, moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive oil as the main source of fat has been associated with reduced risk of cardiovascular disease (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory Committee. The strongest experimental support for this recommendation derives from the success of the recent PREDIMED CVD outcomes trial, and studies indicating that a Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease risk in comparison to either low-fat or Western dietary patterns. However, in none of these studies were comparisons made between the effects of Mediterranean-style diets with low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a Mediterranean dietary pattern based on that used in the PREDIMED study results in similar improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2) modification of the Mediterranean diet by replacing low-fat dairy products with high-fat dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase LDL-C and apoB but may raise large buoyant LDL particles compared with a standard Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in endothelial function compared to a Western diet.

Condition Intervention
Cardiovascular Disease Dyslipidemia Inflammation Other: Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Plasma LDL-cholesterol [ Time Frame: 3 weeks ]
  • Plasma Apolipoprotein B [ Time Frame: 3 weeks ]
  • Plasma Small LDL concentrations [ Time Frame: 3 weeks ]
  • Plasma Large LDL particle concentrations [ Time Frame: 3 weeks ]
  • Plasma Total LDL particle concentrations [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Plasma triglycerides [ Time Frame: 3 weeks ]
  • Plasma HDL-cholesterol [ Time Frame: 3 weeks ]
  • Plasma apolipoprotein AI [ Time Frame: 3 weeks ]
  • Plasma oxidized LDL [ Time Frame: 3 weeks ]
  • Plasma C-reactive protein [ Time Frame: 3 weeks ]
  • Plasma Interleukin-6 [ Time Frame: 3 weeks ]
  • Plasma Intercellular Adhesion Molecule 1 (ICAM-1) [ Time Frame: 3 weeks ]
  • Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1) [ Time Frame: 3 weeks ]
  • RH-PAT index (endothelial function) [ Time Frame: 3 weeks ]
    Endothelial function measured by finger reactive hyperemia peripheral arterial tonography


Estimated Enrollment: 40
Study Start Date: April 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Western Diet
Dietary Intervention: 3 wks of a typical Western Diet
Other: Dietary Intervention
3 wk dietary intervention with prescribed menus and ~50% foods provided.
Experimental: Mediterranean Diet
Dietary Intervention: 3 wks of a Mediterranean-style diet
Other: Dietary Intervention
3 wk dietary intervention with prescribed menus and ~50% foods provided.
Experimental: Modified Mediterranean Diet
Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products
Other: Dietary Intervention
3 wk dietary intervention with prescribed menus and ~50% foods provided.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 25-35 kg/m2
  • Weight stable for > 3 months
  • Agrees to abstain from alcohol or dietary supplements during the study

Exclusion Criteria:

  • History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
  • Current use of hormones or drugs knowns to affect lipid metabolism
  • Use of nicotine products or recreational drugs
  • Abnormal TSH
  • Pregnant or breastfeeding
  • Total- and LDL- cholesterol > 95th percentile for sex and age
  • Fasting triglyceride > 500 mg/dl
  • Fasting blood sugar > 126 mg/dl
  • Blood pressure >160/95 mm Hg
  • Allergy to or unwillingness to consume study foods
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781675


Locations
United States, California
Cholesterol Research Center
Berkeley, California, United States, 94705
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Dairy Management Inc.
Investigators
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT02781675     History of Changes
Other Study ID Numbers: 2016-012
First Submitted: May 20, 2016
First Posted: May 24, 2016
Last Update Posted: November 6, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital & Research Center Oakland:
Diet
Mediterranean
Cholesterol
Inflammation

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Dyslipidemias
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases