The Mediterranean Full-Fat Dairy Study (MFFD)
Primary Purpose
Cardiovascular Disease, Dyslipidemia, Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Disease focused on measuring Diet, Mediterranean, Cholesterol, Inflammation
Eligibility 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
Sites / Locations
- Cholesterol Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Western Diet
Mediterranean Diet
Modified Mediterranean Diet
Arm Description
Dietary Intervention: 3 wks of a typical Western Diet
Dietary Intervention: 3 wks of a Mediterranean-style diet
Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products
Outcomes
Primary Outcome Measures
Plasma LDL-cholesterol
Plasma Apolipoprotein B
Plasma Small LDL concentrations
Plasma Large LDL particle concentrations
Plasma Total LDL particle concentrations
Secondary Outcome Measures
Plasma triglycerides
Plasma HDL-cholesterol
Plasma apolipoprotein AI
Plasma oxidized LDL
Plasma C-reactive protein
Plasma Interleukin-6
Plasma Intercellular Adhesion Molecule 1 (ICAM-1)
Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)
RH-PAT index (endothelial function)
Endothelial function measured by finger reactive hyperemia peripheral arterial tonography
Full Information
NCT ID
NCT02781675
First Posted
May 20, 2016
Last Updated
July 31, 2019
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Dairy Management Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02781675
Brief Title
The Mediterranean Full-Fat Dairy Study
Acronym
MFFD
Official Title
Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
Dairy Management Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Dyslipidemia, Inflammation
Keywords
Diet, Mediterranean, Cholesterol, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Western Diet
Arm Type
Experimental
Arm Description
Dietary Intervention: 3 wks of a typical Western Diet
Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Dietary Intervention: 3 wks of a Mediterranean-style diet
Arm Title
Modified Mediterranean Diet
Arm Type
Experimental
Arm Description
Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
3 wk dietary intervention with prescribed menus and ~50% foods provided.
Primary Outcome Measure Information:
Title
Plasma LDL-cholesterol
Time Frame
3 weeks
Title
Plasma Apolipoprotein B
Time Frame
3 weeks
Title
Plasma Small LDL concentrations
Time Frame
3 weeks
Title
Plasma Large LDL particle concentrations
Time Frame
3 weeks
Title
Plasma Total LDL particle concentrations
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Plasma triglycerides
Time Frame
3 weeks
Title
Plasma HDL-cholesterol
Time Frame
3 weeks
Title
Plasma apolipoprotein AI
Time Frame
3 weeks
Title
Plasma oxidized LDL
Time Frame
3 weeks
Title
Plasma C-reactive protein
Time Frame
3 weeks
Title
Plasma Interleukin-6
Time Frame
3 weeks
Title
Plasma Intercellular Adhesion Molecule 1 (ICAM-1)
Time Frame
3 weeks
Title
Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)
Time Frame
3 weeks
Title
RH-PAT index (endothelial function)
Description
Endothelial function measured by finger reactive hyperemia peripheral arterial tonography
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Krauss, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cholesterol Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Mediterranean Full-Fat Dairy Study
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