Cardiovascular DiseaseMFFDNCT02781675
The Mediterranean Full-Fat Dairy Study
A study testing Dietary Intervention in people with Cardiovascular Disease and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Dyslipidemia, Inflammation
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2018
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-35 kg/m2
- Weight stable for > 3 months
- Agrees to abstain from alcohol or dietary supplements during the study
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center
Berkeley, California, 94705
About this study
Official title: Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults
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.
- Conditions
- Cardiovascular Disease, Dyslipidemia, Inflammation
- Being tested
- Dietary Intervention
- Keywords
- Diet, Mediterranean, Cholesterol, Inflammation
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
3 wk dietary intervention with prescribed menus and ~50% foods provided.
| Study group | Role | What they receive |
|---|---|---|
| Western Diet | Experimental | Dietary Intervention: 3 wks of a typical Western Diet Receives: Other: Dietary Intervention |
| Mediterranean Diet | Experimental | Dietary Intervention: 3 wks of a Mediterranean-style diet Receives: Other: Dietary Intervention |
| Modified Mediterranean Diet | Experimental | Dietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma LDL-cholesterol
Measured: 3 weeks
Plasma Apolipoprotein B
Measured: 3 weeks
Plasma Small LDL concentrations
Measured: 3 weeks
Plasma Large LDL particle concentrations
Measured: 3 weeks
Plasma Total LDL particle concentrations
Measured: 3 weeks
Secondary outcomes (9)
Plasma triglycerides
Measured: 3 weeks
Plasma HDL-cholesterol
Measured: 3 weeks
Plasma apolipoprotein AI
Measured: 3 weeks
Plasma oxidized LDL
Measured: 3 weeks
Plasma C-reactive protein
Measured: 3 weeks
Plasma Interleukin-6
Measured: 3 weeks
Plasma Intercellular Adhesion Molecule 1 (ICAM-1)
Measured: 3 weeks
Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)
Measured: 3 weeks
RH-PAT index (endothelial function)
Endothelial function measured by finger reactive hyperemia peripheral arterial tonography
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, MD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781675
- Sponsor's protocol ID
- 2016-012
- Acronym
- MFFD
- Status last verified
- Jul 2018
- First submitted
- 20 May 2016
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults
- ClinicalTrials.gov ID
- NCT02781675
- Acronym / sponsor ID
- MFFD / 2016-012
- Conditions
- Cardiovascular Disease, Dyslipidemia, Inflammation
- Keywords
- Diet, Mediterranean, Cholesterol, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Western Diet | Experimental | Other: Dietary InterventionDietary Intervention: 3 wks of a typical Western Diet |
| Mediterranean Diet | Experimental | Other: Dietary InterventionDietary Intervention: 3 wks of a Mediterranean-style diet |
| Modified Mediterranean Diet | Experimental | Other: Dietary InterventionDietary Intervention: 3 wks of a Mediterranean-style diet including full fat dairy products |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 25-35 kg/m2
- Weight stable for > 3 months
- Agrees to abstain from alcohol or dietary supplements during the study
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Intervention3 wk dietary intervention with prescribed menus and ~50% foods provided. | Other | Mediterranean Diet, Modified Mediterranean Diet, Western Diet |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Krauss, MD principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Cardiovascular Disease and Dyslipidemia, run by UCSF Benioff Children's Hospital Oakland 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 3 inclusion and 10 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 2 Aug 2019. 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?
Plasma LDL-cholesterol (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2019.