Metabolic Syndrome XNCT00362908
Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome
A study testing Moderate Fat and Moderate Carbohydrate Diet and Low Fat and High Carbohydrate Diet in people with Metabolic Syndrome X and Dyslipidemias, run by University of Washington at 1 site in United States.
Trial summary
The metabolic syndrome consists of five concurrent conditions which increase risk of heart disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high triglyceride and low HDL levels and are overweight. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Dyslipidemias
- What is being tested?
- Moderate Fat and Moderate Carbohydrate Diet and Low Fat and High Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2010
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Metabolic Syndrome: individuals must have at least three of the following five criteria:
- Abdominal obesity greater than 90 cm in Asian men, greater than 102 cm in all other men, greater than 80 cm in Asian women, and greater than 88 cm in all other women
- Triglycerides greater than or equal to 150 mg/dL at two screening visits (Required for the purposes of this study, which focuses on the dyslipidemic phenotype)
- HDL cholesterol levels less than 40 mg/dL in men and less than 50 mg/dL in women
- Blood pressure levels greater than 130/85 mmHg or taking an allowed blood pressure medication at Visit 1 (see definition in exclusions below)
- Fasting glucose greater than or equal to 100mg/dL at Visit 1
Who cannot join
- LDL greater than or equal to 190 mg/dL
- Triglycerides greater than 500mg/dL at Visit 1
- Blood pressure over a mean of 150/95 at the two first visits
- Body mass index greater than 40 kg/m²
- Currently taking any lipid lowering medication other than statins
- Currently taking high doses of thiazide diuretics (greater than 50mg/day), or any other blood pressure medication in the past 4 weeks
Show all 17Show fewer
- Use of plant sterols from sources such as Benecol or Take Control margarines in the past 4 weeks
- Use of any fish oil supplements in the week prior to screening
- Blood glucose greater than 140 mg/dL or use of diabetes medications
- Hospitalization for coronary disease in the last 6 months
- Use of nitroglycerin or other nitrates
- Unstable liver, renal, gastrointestinal or pulmonary disease or mental disease, or medically unstable for other reasons
- Alcohol intake greater than 2 drinks/day, any illegal drug use, smoking, chronic NSAID use or NSAID use within 5 days before the BAR study
- Pregnancy intended within one year or one year prior or currently lactating
- In reproductive age women, an irregular menstrual cycle (must have consistent menstrual cycle between 24 to 32 days)
- Use or expectation of use of oral or patch contraceptive
- Unable or unlikely to be able to comply with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Lipid Research Clinic
Seattle, Washington, 98104
About this study
Official title: Diets for Dyslipidemia in the Metabolic Syndrome
The metabolic syndrome consists of five concurrent conditions which increase risk of heart disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high triglyceride and low HDL levels and are overweight. Low fat, high carbohydrate diets may not provide the same cholesterol-lowering benefits to obese individuals as they do to non-obese individuals. The purpose of this study is to compare the effects of a low fat, high carbohydrate diet versus a moderate fat, moderate carbohydrate diet on the heart, blood vessels, and cholesterol levels in individuals with metabolic syndrome.
Read the detailed description
The Metabolic Syndrome is characterized by elevated insulin levels, excess body fat in the waist, and elevated levels of glucose and blood pressure, and dyslipidemia. Dyslipidemia in the Metabolic Syndrome is characterized by high levels of triglycerides, low levels of HDL cholesterol, and above average LDL and non-HDL cholesterol. Individuals with elevated LDL cholesterol have traditionally been advised to follow a low fat, high carbohydrate diet. However, research has shown that this diet does not adequately regulate cholesterol levels in individuals with dyslipidemia. A diet consisting of more moderate amounts of fats and carbohydrates may be more beneficial for individuals with the dyslipidemia of the metabolic syndrome. The purpose of this study is to compare the effects of a diet moderate in fat and carbohydrate versus a low fat, high carbohydrate diet on the cholesterol levels, inflammatory factors and vascular response in individuals with metabolic syndrome.
During the initial screening period, participants follow an American Heart Association (AHA) Step 1 diet and cholesterol levels are tested for eligibility under the criteria of the Metabolic Syndrome. Before being randomized, eligible participants have a frequently sampled intravenous glucose tolerance test (FSIVGTT), an abdominal CT scan to measure fat content in two locations and two brachial artery reactivity tests. The FSIVGTT provides information about whether participants are insulin sensitive or insulin resistant. The CT scan measures the fat content in the abdomen and the liver. The brachial artery reactivity tests measure blood flow through the brachial artery in the arm.
This 7-month study consists of two 1-month feeding periods, a rest month between the two feeding periods and a 4-month follow-up diet in a free-living setting. In Month 1, participants are randomly assigned to follow either a moderate fat, moderate carbohydrate diet or a low fat, high carbohydrate diet. Participants receive prepared food at study visits twice a week. Weight and vital signs are measured at each study visit, and blood is collected at baseline, and Weeks 3-1/2 and 4. A brachial artery reactivity test, using an ultrasound to measure artery size and blood flow in the arm, is performed twice in Week 4. In the Month 2 rest period, participants follow an AHA Step 1 diet at home. In Month 3, participants switch to the other diet and all study procedures and evaluations are repeated as in Month 1. During the following Months 4 through 7, participants continue following the second assigned diet, but are responsible for preparing their own food. They meet with a dietician once a week for 1 month to learn how to prepare meals at home. During this 4-month period, blood collection, vital sign measurements, and review of medical history and diet continue at monthly visits. At the end of Month 7, participants again undergo two brachial artery reactivity tests.
As of October, 2010, 148 were screened with 71 eligible to be randomized. Seven discontinued prior to completion and 64 completed the 7 month study. The intervention is complete and analyses are ongoing.
- Conditions
- Metabolic Syndrome X, Dyslipidemias
- Being tested
- Moderate Fat and Moderate Carbohydrate Diet, Low Fat and High Carbohydrate Diet
- Keywords
- Obesity, Hypertension, Insulin Resistance
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Obesity, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Fat and Moderate Carbohydrate DietBehavioural
40% allowable fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months
Low Fat and High Carbohydrate DietBehavioural
20% fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects consume study diets in the following order:
1. Diet 1 (20% fat diet) for 1 month with all food provided,
2. American Heart Association Step I Diet for 1 month at home, and
3. Diet 2 (40% fat diet) for 1 month with all food provided and then continue to follow this diet for an additional 4 months at home. Receives: Behavioral: Moderate Fat and Moderate Carbohydrate Diet; Behavioral: Low Fat and High Carbohydrate Diet |
| Group 2 | Active comparator | Subjects consume study diets in the following order:
1. Diet 2 (40% fat diet) for 1 month with all food provided,
2. American Heart Association Step I Diet for 1 month at home, and
3. Diet 1 (20% fat diet) for 1 month with all food provided and then continue to follow this diet for an additional 4 months at home. Receives: Behavioral: Moderate Fat and Moderate Carbohydrate Diet; Behavioral: Low Fat and High Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-HDL cholesterol
Measured: Measured at screening, baseline, at the beginning and end of the 1st and 2nd diet periods, and at the end of each month for four months during the diet extension
C-reactive protein
Measured: Measured at the beginning and end of the 1st and 2nd diet periods and at the end of the four month diet extension
Brachial artery reactivity
Measured: Two measurements are done at the beginning and end the 1st and 2nd diet periods and at the end of the four month diet extension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Pathmaja Paramsothy, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362908
- Sponsor's protocol ID
- 29854-B
- Other IDs
- R01HL083117, 422
- Status last verified
- Oct 2010
- First submitted
- 10 Aug 2006
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Knopp RH, Fish B, Dowdy A, Retzlaff B, Walden C, Rusanu I, Paramsothy P. A moderate-fat diet for combined hyperlipidemia and metabolic syndrome. Curr Atheroscler Rep. 2006 Nov;8(6):492-500. doi: 10.1007/s11883-006-0025-9.
PubMed 17045076Paramsothy P, Krieger E, Chan E, Fish B, Dowdy A, Knopp RH. Abstract 1017: Moderate vs Low Fat Diet Effects on Lipids and Inflammation in Metabolic Syndrome. Circulation, Nov 2009; 120: S426. Presented as oral abstract at AHA Annual Scientific Session November, 2009.
Paramsothy P, Kreiger E, Chan E, Preus E, Rusanu I, Prager S, Knopp RH. Effects Of Low Fat Vs. Moderate Fat Diet On Insulin Resistance And Endothelial Function In Metabolic Syndrome. J. Am. Coll. Cardiol., March 9, 2010; 55: A58.E555. Presented as poster at ACC, Atlanta, GA. 3/10.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diets for Dyslipidemia in the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00362908
- Acronym / sponsor ID
- 29854-B
- Conditions
- Metabolic Syndrome X, Dyslipidemias
- Keywords
- Obesity, Hypertension, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Aug 2006 (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.
The metabolic syndrome consists of five concurrent conditions which increase risk of heart disease, stroke, and diabetes. Persons with the metabolic syndrome usually have high triglyceride and low HDL levels and are overweight. Low fat, high carbohydrate diets may not provide the same cholesterol-lowering benefits to obese individuals as they do to non-obese individuals. The purpose of this study is to compare the effects of a low fat, high carbohydrate diet versus a moderate fat, moderate carbohydrate diet on the heart, blood vessels, and cholesterol levels in individuals with metabolic syndrome.
Detailed description
The Metabolic Syndrome is characterized by elevated insulin levels, excess body fat in the waist, and elevated levels of glucose and blood pressure, and dyslipidemia. Dyslipidemia in the Metabolic Syndrome is characterized by high levels of triglycerides, low levels of HDL cholesterol, and above average LDL and non-HDL cholesterol. Individuals with elevated LDL cholesterol have traditionally been advised to follow a low fat, high carbohydrate diet. However, research has shown that this diet does not adequately regulate cholesterol levels in individuals with dyslipidemia. A diet consisting of more moderate amounts of fats and carbohydrates may be more beneficial for individuals with the dyslipidemia of the metabolic syndrome. The purpose of this study is to compare the effects of a diet moderate in fat and carbohydrate versus a low fat, high carbohydrate diet on the cholesterol levels, inflammatory factors and vascular response in individuals with metabolic syndrome.
During the initial screening period, participants follow an American Heart Association (AHA) Step 1 diet and cholesterol levels are tested for eligibility under the criteria of the Metabolic Syndrome. Before being randomized, eligible participants have a frequently sampled intravenous glucose tolerance test (FSIVGTT), an abdominal CT scan to measure fat content in two locations and two brachial artery reactivity tests. The FSIVGTT provides information about whether participants are insulin sensitive or insulin resistant. The CT scan measures the fat content in the abdomen and the liver. The brachial artery reactivity tests measure blood flow through the brachial artery in the arm.
This 7-month study consists of two 1-month feeding periods, a rest month between the two feeding periods and a 4-month follow-up diet in a free-living setting. In Month 1, participants are randomly assigned to follow either a moderate fat, moderate carbohydrate diet or a low fat, high carbohydrate diet. Participants receive prepared food at study visits twice a week. Weight and vital signs are measured at each study visit, and blood is collected at baseline, and Weeks 3-1/2 and 4. A brachial artery reactivity test, using an ultrasound to measure artery size and blood flow in the arm, is performed twice in Week 4. In the Month 2 rest period, participants follow an AHA Step 1 diet at home. In Month 3, participants switch to the other diet and all study procedures and evaluations are repeated as in Month 1. During the following Months 4 through 7, participants continue following the second assigned diet, but are responsible for preparing their own food. They meet with a dietician once a week for 1 month to learn how to prepare meals at home. During this 4-month period, blood collection, vital sign measurements, and review of medical history and diet continue at monthly visits. At the end of Month 7, participants again undergo two brachial artery reactivity tests.
As of October, 2010, 148 were screened with 71 eligible to be randomized. Seven discontinued prior to completion and 64 completed the 7 month study. The intervention is complete and analyses are ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Moderate Fat and Moderate Carbohydrate Diet, Behavioral: Low Fat and High Carbohydrate DietSubjects consume study diets in the following order: 1. Diet 1 (20% fat diet) for 1 month with all food provided, 2. American Heart Association Step I Diet for 1 month at home, and 3. Diet 2 (40% fat diet) for 1 month with all food provided and then continue to follow this diet for an additional 4 months at home. |
| Group 2 | Active comparator | Behavioral: Moderate Fat and Moderate Carbohydrate Diet, Behavioral: Low Fat and High Carbohydrate DietSubjects consume study diets in the following order: 1. Diet 2 (40% fat diet) for 1 month with all food provided, 2. American Heart Association Step I Diet for 1 month at home, and 3. Diet 1 (20% fat diet) for 1 month with all food provided and then continue to follow this diet for an additional 4 months at home. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Metabolic Syndrome: individuals must have at least three of the following five criteria:
Key exclusion criteria (17 listed)
- LDL greater than or equal to 190 mg/dL
- Triglycerides greater than 500mg/dL at Visit 1
- Blood pressure over a mean of 150/95 at the two first visits
- Body mass index greater than 40 kg/m²
- Currently taking any lipid lowering medication other than statins
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 |
|---|---|---|
| Moderate Fat and Moderate Carbohydrate Diet40% allowable fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months | Behavioural | Group 1, Group 2 |
| Low Fat and High Carbohydrate Diet20% fat diet (less than or equal to 7% saturated fat) consumed for 1 or 5 months | Behavioural | Group 1, Group 2 |
Primary outcome
Non-HDL cholesterol
Time frame: Measured at screening, baseline, at the beginning and end of the 1st and 2nd diet periods, and at the end of each month for four months during the diet extension
C-reactive protein
Time frame: Measured at the beginning and end of the 1st and 2nd diet periods and at the end of the four month diet extension
Brachial artery reactivity
Time frame: Two measurements are done at the beginning and end the 1st and 2nd diet periods and at the end of the four month diet extension
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 28 Oct 2010.
- Background: PubMed 17045076Knopp RH, Fish B, Dowdy A, Retzlaff B, Walden C, Rusanu I, Paramsothy P. A moderate-fat diet for combined hyperlipidemia and metabolic syndrome. Curr Atheroscler Rep. 2006 Nov;8(6):492-500. doi: 10.1007/s11883-006-0025-9.
- Results publicationParamsothy P, Krieger E, Chan E, Fish B, Dowdy A, Knopp RH. Abstract 1017: Moderate vs Low Fat Diet Effects on Lipids and Inflammation in Metabolic Syndrome. Circulation, Nov 2009; 120: S426. Presented as oral abstract at AHA Annual Scientific Session November, 2009.
- Results publicationParamsothy P, Kreiger E, Chan E, Preus E, Rusanu I, Prager S, Knopp RH. Effects Of Low Fat Vs. Moderate Fat Diet On Insulin Resistance And Endothelial Function In Metabolic Syndrome. J. Am. Coll. Cardiol., March 9, 2010; 55: A58.E555. Presented as poster at ACC, Atlanta, GA. 3/10.
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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.
Pathmaja Paramsothy, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Fat and Moderate Carbohydrate Diet and Low Fat and High Carbohydrate Diet in people with Metabolic Syndrome X and Dyslipidemias, run by University of Washington 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 17 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 28 Oct 2010. 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?
Non-HDL cholesterol (time frame: Measured at screening, baseline, at the beginning and end of the 1st and 2nd diet periods, and at the end of each month for four months during the diet extension). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362908, which also lists 3 linked publications.
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 28 Oct 2010.