Metabolic SyndromeMUFAPUFANCT00852475
Comparative Effects of 2 Diets in Veterans With the Metabolic Syndrome
A study testing MUFA MOVE! (Monounsaturated fatty enriched diet) and PUFA MOVE! (Polyunsaturated fatty acid enriched diet) in people with Metabolic Syndrome, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet combined with the VA Managing Overweight/Obesity for Veterans Everywhere (MOVE!) program so as to determine which one is superior in… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- MUFA MOVE! (Monounsaturated fatty enriched diet) and PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of 3 or more of the following):
- Waist circumference >102 cm in men or >88 cm women
- Treated Hypertension or Untreated Blood pressure >130/85 and < 160/100 mm Hg
- Treated Hyperglycemia or Untreated Fasting blood glucose (FBG) >100 mg/dL (based on 2006 guidelines)
- Treated Hyperlipidemia or Untreated Triglycerides > 150 mg/dL
- HDL-C < 40 mg/dL men < 50 mg/dL women
Who cannot join
- Decompensated heart failure (NYHA Class IV);
- Severe Pulmonary disease (Unable to walk on a treadmill at 2.5 mph or greater);
- Chronic renal insufficiency (Cr > 2.5 mg/dL)
- Treated diabetes mellitus with FBG > 180 mg/dL or HbA1C >9g %
- Hematologic or malignant disorders
- Treated SBP >160 mmHg and/or DBP > 95 mmHg ;
Show all 12Show fewer
- Treated TG > 250 mg/dL
- Use of systemic vasodilators (e.g., nitrates)
- Morbid Obesity (BMI > 50 kg/m2)
- Endocrine (thyroid) or metabolic disorders (unless treated and under control)
- Alcohol consumption greater than (2) 4-ounce glasses of table wine, (2) 12-oz bottles of beer or 2 shots of spirits in men or women
- Active IV drug abuse within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome
The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet combined with the VA Managing Overweight/Obesity for Veterans Everywhere (MOVE!) program so as to determine which one is superior in reducing cardiometabolic risk factors associated with Metabolic Syndrome. The risk factors considered include lipids and lipoproteins, inflammatory markers such as CRP and adiponectin, endothelium-dependent flow-mediated vasodilatation (FMD) and the postprandial lipid responses to a meal.
Cardiometabolic risk factors will be determined by measuring several cardiovascular risk associated parameters including:
Read more
Biochemical measurements of lipids and inflammatory markers, body composition and VO2max (Specific Objective 1, Descriptive).
Postprandial response to a meal challenge and endothelial vasoreactivity (FMD) assessed by BART (Specific Objective 2, Physiological).
Determination of the effects on postheparin lipases and transfer protein activity, visceral adipose tissue (VAT) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) (Specific Objective 3, Mechanistic)
Read the detailed description
The Metabolic Syndrome (MetS) is a common problem among Veterans and is associated with a greater likelihood of cardiovascular disease (CVD). The Mediterranean diet is the only popular diet that has been shown to reduce CVD event rates but the extent to which monounsaturated fatty acid (MUFA) or polyunsaturated fatty acid (PUFA) enrichment results in improvement in parameters of MetS is unresolved. Similarly, while low intensity exercise improves the CVD risk factor profile, there have been no comparative investigations comparing MUFA and PUFA enriched diets and exercise in patients with MetS that have extended beyond 1 year. Recently, the VA established the MOVE! program, a national weight management program designed to help Veterans lose weight. Using the VA promoted program, we will perform a systematic evaluation of the effects of dietary fat composition [comparison between MUFA-enriched and PUFA enriched diet] with MOVE!. We hypothesize that a MUFA-enriched diet consisting of antioxidant, lipid reducing and insulin sensitizing properties will be superior to the less palatable PUFA-enriched diet on improving cardiometabolic parameters associated with MetS. Specifically, the MUFA MOVE! program is expected to lead to greater improvements than the PUFA MOVE! program in body composition and aerobic fitness (Specific Aim 1), endothelial dependent flow mediated vasodilatation and the postprandial lipid response to a meal load (Specific Aim 2) and the mechanisms (lipolytic and lipid transfer protein activity, homeostasis model assessment-estimated insulin resistance) responsible for these effects (Specific Aim 3). Collectively, these studies will advance our understanding of mechanisms underlying the differential effects of MUFA and PUFA-enriched dietary regimens on cardiometabolic health and when combined with the MOVE! program, will provide new and useful information to Veterans (and the general public) interested in optimizing their diets for CVD disease prevention and improved vascular health.
- Conditions
- Metabolic Syndrome
- Being tested
- MUFA MOVE! (Monounsaturated fatty enriched diet), PUFA MOVE! (Polyunsaturated fatty acid enriched diet)
- Keywords
- MUFA, PUFA, MOVE! program
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUFA MOVE! (Monounsaturated fatty enriched diet)Dietary supplement
MUFA MOVE!diet and exercise program
PUFA MOVE! (Polyunsaturated fatty acid enriched diet)Dietary supplement
PUFA MOVE! diet and exercise program
| Study group | Role | What they receive |
|---|---|---|
| MUFA | Placebo comparator | Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program Receives: Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet) |
| PUFA | Active comparator | Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program Receives: Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Changes in Veterans With MetS.
Measured: 6 months from Baseline
Secondary outcomes (1)
Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .
Ultrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.
Measured: 6 months from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Michael Miller, MD, Principal investigator, VA Maryland Health Care System, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852475
- Sponsor's protocol ID
- CARA-030-08F
- Other IDs
- HP-00040456
- Acronym
- MUFAPUFA
- Status last verified
- Dec 2016
- First submitted
- 26 Feb 2009
- Last updated
- 2 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Two Popular Diets in Veterans With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00852475
- Acronym / sponsor ID
- MUFAPUFA / CARA-030-08F
- Conditions
- Metabolic Syndrome
- Keywords
- MUFA, PUFA, MOVE! program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Maryland
- Study start
- Feb 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 2 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine the effects of 2 commonly used diets, a Mediterranean monounsaturated fatty acid enriched (MUFA) or AHA polyunsaturated (PUFA) enriched diet combined with the VA Managing Overweight/Obesity for Veterans Everywhere (MOVE!) program so as to determine which one is superior in reducing cardiometabolic risk factors associated with Metabolic Syndrome. The risk factors considered include lipids and lipoproteins, inflammatory markers such as CRP and adiponectin, endothelium-dependent flow-mediated vasodilatation (FMD) and the postprandial lipid responses to a meal.
Cardiometabolic risk factors will be determined by measuring several cardiovascular risk associated parameters including:
Biochemical measurements of lipids and inflammatory markers, body composition and VO2max (Specific Objective 1, Descriptive).
Postprandial response to a meal challenge and endothelial vasoreactivity (FMD) assessed by BART (Specific Objective 2, Physiological).
Determination of the effects on postheparin lipases and transfer protein activity, visceral adipose tissue (VAT) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) (Specific Objective 3, Mechanistic)
Detailed description
The Metabolic Syndrome (MetS) is a common problem among Veterans and is associated with a greater likelihood of cardiovascular disease (CVD). The Mediterranean diet is the only popular diet that has been shown to reduce CVD event rates but the extent to which monounsaturated fatty acid (MUFA) or polyunsaturated fatty acid (PUFA) enrichment results in improvement in parameters of MetS is unresolved. Similarly, while low intensity exercise improves the CVD risk factor profile, there have been no comparative investigations comparing MUFA and PUFA enriched diets and exercise in patients with MetS that have extended beyond 1 year. Recently, the VA established the MOVE! program, a national weight management program designed to help Veterans lose weight. Using the VA promoted program, we will perform a systematic evaluation of the effects of dietary fat composition [comparison between MUFA-enriched and PUFA enriched diet] with MOVE!. We hypothesize that a MUFA-enriched diet consisting of antioxidant, lipid reducing and insulin sensitizing properties will be superior to the less palatable PUFA-enriched diet on improving cardiometabolic parameters associated with MetS. Specifically, the MUFA MOVE! program is expected to lead to greater improvements than the PUFA MOVE! program in body composition and aerobic fitness (Specific Aim 1), endothelial dependent flow mediated vasodilatation and the postprandial lipid response to a meal load (Specific Aim 2) and the mechanisms (lipolytic and lipid transfer protein activity, homeostasis model assessment-estimated insulin resistance) responsible for these effects (Specific Aim 3). Collectively, these studies will advance our understanding of mechanisms underlying the differential effects of MUFA and PUFA-enriched dietary regimens on cardiometabolic health and when combined with the MOVE! program, will provide new and useful information to Veterans (and the general public) interested in optimizing their diets for CVD disease prevention and improved vascular health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUFA | Placebo comparator | Dietary Supplement: MUFA MOVE! (Monounsaturated fatty enriched diet)Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program |
| PUFA | Active comparator | Dietary Supplement: PUFA MOVE! (Polyunsaturated fatty acid enriched diet)Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Waist circumference >102 cm in men or >88 cm women
- Treated Hypertension or Untreated Blood pressure >130/85 and < 160/100 mm Hg
- Treated Hyperglycemia or Untreated Fasting blood glucose (FBG) >100 mg/dL (based on 2006 guidelines)
- Treated Hyperlipidemia or Untreated Triglycerides > 150 mg/dL
- HDL-C < 40 mg/dL men < 50 mg/dL women
Key exclusion criteria (12 listed)
- Decompensated heart failure (NYHA Class IV);
- Severe Pulmonary disease (Unable to walk on a treadmill at 2.5 mph or greater);
- Chronic renal insufficiency (Cr > 2.5 mg/dL)
- Treated diabetes mellitus with FBG > 180 mg/dL or HbA1C >9g %
- Hematologic or malignant disorders
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 |
|---|---|---|
| MUFA MOVE! (Monounsaturated fatty enriched diet)MUFA MOVE!diet and exercise program | Dietary supplement | MUFA |
| PUFA MOVE! (Polyunsaturated fatty acid enriched diet)PUFA MOVE! diet and exercise program | Dietary supplement | PUFA |
Primary outcome
Weight Changes in Veterans With MetS.
Time frame: 6 months from Baseline
1 secondary outcome
Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .
Time frame: 6 months from Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Miller, MD principal investigator
VA Maryland Health Care System, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUFA MOVE! (Monounsaturated fatty enriched diet) and PUFA MOVE! (Polyunsaturated fatty acid enriched diet) in people with Metabolic Syndrome, run by VA Office of Research and Development 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 6 inclusion and 12 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 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Changes in Veterans With MetS. (time frame: 6 months from Baseline). 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 Feb 2017.