ObesityPhase 2NCT00166088
Effect of a Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and Endothelial Progenitor Cells (EPC's)
A Phase 2 study testing Mediterranean Diet and Mediterranean Dietary Supplement in people with Obesity, run by Emory University at 1 site in United States.
Trial summary
Problem of Interest: A typical American diet that is high in an intake of fats (especially saturated fats and cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries, and increases the risk of heart disease. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Mediterranean Diet and Mediterranean Dietary Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 2006
- Phase
- Phase 2
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index [BMI; body weight (kg)/height (m)2] greater than or equal to 28 and less than 35
- Stable body weight in the past 6 months (weight change < 2 kg)
- Non-smokers
- Currently consuming a stable habitual diet as assessed by interview with a nutritionist and 24 hour diet recall showing:
- saturated + trans fat intake of > 10% of total daily calories; and
- total cholesterol intake of > 300 mg/day
- Not consuming antioxidants or vitamin-mineral preparations in the last 4 weeks
Who cannot join
- History of significant cardiovascular disease
- Cancer other than remote history of skin cancer
- Diabetes mellitus by history or fasting plasma glucose (FPG) > 126mg/dL
- Excessive chronic alcohol consumption (averaging > two alcoholic beverages/day)
- Known acute or chronic illness, including psychiatric problems that will, in the opinion of the principal investigator (PI), make one ineligible for the study
- Statin or other hypolipidemic therapy
Show all 13Show fewer
- Current intake of vitamins and supplements
- Inability to return to Emory for follow-up, blood drawing
- Pregnant or lactating females
- Unable to give informed consent
- Hematocrit < 30%
- Uncontrolled hypertension with systolic blood pressure (SBP) > 180 and diastolic blood pressure (DBP) > 110
- History of bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and EPC's
Problem of Interest:
A typical American diet that is high in an intake of fats (especially saturated fats and cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries, and increases the risk of heart disease. The American Heart Association recommendations to follow a diet that is low in the amount of fat, and specifically cholesterol, that is eaten can improve blood levels of cholesterol but can lead to a high intake of sugars (especially processed sugars) that can lead to obesity and continued heart problems.
Read more
Studies of people who eat a diet that is typical of the Mediterranean region have shown that this type of diet leads to reductions in heart disease as well as forms of cancer. A typical Mediterranean diet has a large amount of fruit, vegetables, whole grain breads and cereals, beans, potatoes and seeds. Olive oil is the main source of fat and there is a daily use of dairy products (such as cheese and yogurt) in low to moderate amounts. The main meats are fish or poultry with rare red meat. Desserts are usually fruits with rare sweets. Wine is also used in low to moderate amounts with meals.
No isolated aspect of the diet explains all of its benefits, but it is believed that the ingredient of the diet that most helps to reduce the risk of heart disease is the high amount of omega-3 fatty acids. Omega-3 fatty acids are found in fatty fish as well as in nuts and certain oils. Several studies of patients with either known heart disease or risk factors for heart disease have shown a reduction in heart disease events, such as heart attacks, as well as markers of heart disease risk when patients followed a Mediterranean diet. Other studies have shown that giving a supplement that contains omega-3 fatty acids to patients with heart disease or risk factors for heart disease also reduces heart disease events and markers of heart disease risk.
In this current study we, the investigators at Emory University, plan to compare the effects of following a Mediterranean diet versus continuing to follow an American type diet and supplementing parts of the Mediterranean diet, including omega-3 fatty acids, on markers of heart disease risk. A third group will continue to follow their usual diet without supplements to serve as a control.
How Problem Will be Studied:
In this initial study we will compare three groups. One group will receive one month of prepared meals that will follow a Mediterranean diet. This group will also receive extensive counseling and education on how to maintain a Mediterranean diet. During the second month of the study this group will be encouraged to continue following a Mediterranean diet by themselves with assistance from a nutritionist. The second group will be asked to continue on their current diet and receive supplements that are important parts of the Mediterranean diet. These supplements will include an omega-3 fatty acid capsule, walnuts and grape juice. A third group will be asked to continue their current diet and level of activity without supplements to serve as a control. We will follow the effects on markers of heart disease risk. We will also determine if patients are able to continue following a Mediterranean diet on their own or whether simply taking supplements is easier.
Advancement in Scientific Knowledge:
This study will advance scientific knowledge by comparing the effects of following a Mediterranean diet versus simply taking supplements of the believed to be important aspects of the Mediterranean diet. We will also be able to determine if it is easier to follow a Mediterranean diet or take supplements for patients who are currently ingesting a typical American diet.
Standard of Care:
Currently the recommended diet for all Americans is a Step 1 American Heart Association diet that is low in fat and specifically low in saturated fats and cholesterol. As stated above, despite these recommendations, there is a growing problem of obesity in the United States and there is evidence to suggest that a Mediterranean diet may be better.
- Conditions
- Obesity
- Being tested
- Mediterranean Diet, Mediterranean Dietary Supplement
- Keywords
- Oxidative Stress, Diet, Mediterranean
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietDietary supplement
The Mediterranean diet group will receive all meals as a prototypical Mediterranean diet for 4 consecutive weeks prepared by the GCRC metabolic kitchen with dietary instruction. During the second month of the study they will be asked to follow a Mediterranean diet using their own home-cooked meals
Mediterranean Dietary SupplementDietary supplement
The subjects randomized to the typical diet + targeted Mediterranean dietary supplement group will not receive dietary counseling. They will be given a one-month supply of specific supplements by the GCRC nutritionists and advised to consume these daily, in addition to their usual diet.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Arm | Experimental | Not described Receives: Dietary Supplement: Mediterranean Diet |
| Mediterranean Dietary Supplement Arm | Active comparator | Not described Receives: Dietary Supplement: Mediterranean Dietary Supplement |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery reactivity to test flow-mediated vasodilation (FMD) as a measure of endothelial function.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed A. Quyyumi, Emory University
- Investigators
- Arshed A Quyyumi, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166088
- Sponsor's protocol ID
- 0020-2005
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2005
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and EPC's
- ClinicalTrials.gov ID
- NCT00166088
- Acronym / sponsor ID
- 0020-2005
- Conditions
- Obesity
- Keywords
- Oxidative Stress, Diet, Mediterranean
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 14 Sep 2005 (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.
Problem of Interest:
A typical American diet that is high in an intake of fats (especially saturated fats and cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arteries, and increases the risk of heart disease. The American Heart Association recommendations to follow a diet that is low in the amount of fat, and specifically cholesterol, that is eaten can improve blood levels of cholesterol but can lead to a high intake of sugars (especially processed sugars) that can lead to obesity and continued heart problems.
Studies of people who eat a diet that is typical of the Mediterranean region have shown that this type of diet leads to reductions in heart disease as well as forms of cancer. A typical Mediterranean diet has a large amount of fruit, vegetables, whole grain breads and cereals, beans, potatoes and seeds. Olive oil is the main source of fat and there is a daily use of dairy products (such as cheese and yogurt) in low to moderate amounts. The main meats are fish or poultry with rare red meat. Desserts are usually fruits with rare sweets. Wine is also used in low to moderate amounts with meals.
No isolated aspect of the diet explains all of its benefits, but it is believed that the ingredient of the diet that most helps to reduce the risk of heart disease is the high amount of omega-3 fatty acids. Omega-3 fatty acids are found in fatty fish as well as in nuts and certain oils. Several studies of patients with either known heart disease or risk factors for heart disease have shown a reduction in heart disease events, such as heart attacks, as well as markers of heart disease risk when patients followed a Mediterranean diet. Other studies have shown that giving a supplement that contains omega-3 fatty acids to patients with heart disease or risk factors for heart disease also reduces heart disease events and markers of heart disease risk.
In this current study we, the investigators at Emory University, plan to compare the effects of following a Mediterranean diet versus continuing to follow an American type diet and supplementing parts of the Mediterranean diet, including omega-3 fatty acids, on markers of heart disease risk. A third group will continue to follow their usual diet without supplements to serve as a control.
How Problem Will be Studied:
In this initial study we will compare three groups. One group will receive one month of prepared meals that will follow a Mediterranean diet. This group will also receive extensive counseling and education on how to maintain a Mediterranean diet. During the second month of the study this group will be encouraged to continue following a Mediterranean diet by themselves with assistance from a nutritionist. The second group will be asked to continue on their current diet and receive supplements that are important parts of the Mediterranean diet. These supplements will include an omega-3 fatty acid capsule, walnuts and grape juice. A third group will be asked to continue their current diet and level of activity without supplements to serve as a control. We will follow the effects on markers of heart disease risk. We will also determine if patients are able to continue following a Mediterranean diet on their own or whether simply taking supplements is easier.
Advancement in Scientific Knowledge:
This study will advance scientific knowledge by comparing the effects of following a Mediterranean diet versus simply taking supplements of the believed to be important aspects of the Mediterranean diet. We will also be able to determine if it is easier to follow a Mediterranean diet or take supplements for patients who are currently ingesting a typical American diet.
Standard of Care:
Currently the recommended diet for all Americans is a Step 1 American Heart Association diet that is low in fat and specifically low in saturated fats and cholesterol. As stated above, despite these recommendations, there is a growing problem of obesity in the United States and there is evidence to suggest that a Mediterranean diet may be better.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Arm | Experimental | Dietary Supplement: Mediterranean Diet |
| Mediterranean Dietary Supplement Arm | Active comparator | Dietary Supplement: Mediterranean Dietary Supplement |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index [BMI; body weight (kg)/height (m)2] greater than or equal to 28 and less than 35
- Stable body weight in the past 6 months (weight change < 2 kg)
- Non-smokers
- Currently consuming a stable habitual diet as assessed by interview with a nutritionist and 24 hour diet recall showing:
- Not consuming antioxidants or vitamin-mineral preparations in the last 4 weeks
Key exclusion criteria (13 listed)
- History of significant cardiovascular disease
- Cancer other than remote history of skin cancer
- Diabetes mellitus by history or fasting plasma glucose (FPG) > 126mg/dL
- Excessive chronic alcohol consumption (averaging > two alcoholic beverages/day)
- Known acute or chronic illness, including psychiatric problems that will, in the opinion of the principal investigator (PI), make one ineligible for the study
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 |
|---|---|---|
| Mediterranean DietThe Mediterranean diet group will receive all meals as a prototypical Mediterranean diet for 4 consecutive weeks prepared by the GCRC metabolic kitchen with dietary instruction. During the second month of the study they will be asked to follow a Mediterranean diet using their own home-cooked meals | Dietary supplement | Mediterranean Diet Arm |
| Mediterranean Dietary SupplementThe subjects randomized to the typical diet + targeted Mediterranean dietary supplement group will not receive dietary counseling. They will be given a one-month supply of specific supplements by the GCRC nutritionists and advised to consume these daily, in addition to their usual diet. | Dietary supplement | Mediterranean Dietary Supplement Arm |
Primary outcome
Brachial artery reactivity to test flow-mediated vasodilation (FMD) as a measure of endothelial function.
Time frame: 4 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 18 Nov 2013.
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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.
Arshed A Quyyumi, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mediterranean Diet and Mediterranean Dietary Supplement in people with Obesity, run by Emory 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 7 inclusion and 13 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 18 Nov 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Brachial artery reactivity to test flow-mediated vasodilation (FMD) as a measure of endothelial function. (time frame: 4 Weeks). 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 18 Nov 2013.