Metabolic Syndrome XNCT00269646
Comparison of Two Different Diets on Health Outcomes
A study testing Low-carbohydrate and high-carbohydrate diets in people with Metabolic Syndrome X, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of a low-carbohydrate diet and a high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered risk markers for heart disease, in persons with the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Low-carbohydrate and high-carbohydrate diets
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Aug 2009
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Subjects must meet the criteria of the metabolic syndrome, which is defined as having three or more of the following:
- Waist circumference: >94 cm for males; >80 cm for females
- Blood Pressure: >130/85 mmHg
- HDL-Chol (mg/dl): <50 women; <40 men)
- Triglycerides (mg/dl): >150
- Glucose (mg/dl): >100 2. Subjects must meet age requirement 3. Subjects must be nonsmokers 4. Subjects must be willing to provide written consent 5. Subjects must be willing to pick-up up meals at the GCRC and return uneaten food 6. Have no food allergies 7. Subjects must not be currently following any particular diet, and must not have intentionally lost weight by dieting during the previous 3 months 8. Subjects must not be taking nutritional supplements other than a daily multivitamin 9. Subjects must be willing to maintain current physical activity routine, which cannot exceed the equivalent of > 30 minutes per day of moderate-intensity activity 10. Blood hematocrit must be at least 40 for men and 36 for women.
Who cannot join
- 1. Does not meet the criteria for the metabolic syndrome 2. Does not meet age requirement 3. Smoker 4. Pregnancy 5. Food allergies 6. Unwillingness to provide written consent 7. Personal history of cardiovascular disease, including prior myocardial infarction, angioplasty, or bypass surgery 8. Known cardiovascular or metabolic diseases (e.g., diabetes) 9. Currently using medications to control blood pressure, lipids, or glucose 10. Currently on a diet or has attempted weight loss by dieting during the past 3 months 11. Currently taking nutritional supplements other than a daily multivitamin 12. Currently exercising more than the equivalent of 30 minutes/day of moderate-intensity physical activity 13. Currently on oral contraceptives 14. Hematocrit below 40 for men or below 36 for women 15. Baseline systolic blood pressure below 100 mmHg
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia General Clinical Research Center
Charlottesville, Virginia, 22904
About this study
Official title: Effect of a Low-Carbohydrate and High-Carbohydrate, High-Fiber Diet on Insulin Sensitivity and Risk Markers for Cardiovascular Disease in Men and Women With the Metabolic Syndrome
The purpose of this study is to compare the effects of a low-carbohydrate diet and a high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered risk markers for heart disease, in persons with the metabolic syndrome.
Our primary hypothesis is that the ad libitum high-carbohydrate, high-fiber diet will significantly improve insulin sensitivity, whereas the ad libitum low-carbohydrate, low-fiber diet will not.
Read the detailed description
Low-carbohydrate eating is becoming perceived as more than just a weight loss diet, but rather a means to improve health. Several studies have been published suggesting that low-carbohydrate diets may be preferable to low-fat diets for weight loss and in terms of some health markers. On the other hand, considerable evidence suggests that low-carbohydrate diets, high in fat, are associated with a number of adverse health outcomes. The health benefits of high-carbohydrate, high-fiber diets have also been demonstrated. This study is designed to assess the differences between the two different dietary strategies in terms of a number of health outcomes. Participants will consume, in random order, a non-calorie-restricted low-carbohydrate and a non-calorie-restricted high-carbohydrate, high-fiber diet for one month, with a 4-6 week washout period in between.
- Conditions
- Metabolic Syndrome X
- Being tested
- Low-carbohydrate and high-carbohydrate diets
- Keywords
- Diet, Low-carbohydrate, Insulin, Dietary fiber, Diabetes, Cardiovascular disease
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-carbohydrate and high-carbohydrate dietsBehavioural
Each subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet.
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
Measured: before and after one month on each diet
Secondary outcomes (7)
Total and LDL-cholesterol
Measured: before and after one month on each diet
C-reactive protein
Measured: before and after one month on each diet
Homocysteine
Measured: before and after one month on each diet
Fibrinogen
Measured: before and after one month on each diet
Cytokines IL-1, IL-2, IL-6 and TNF-alpha
Measured: before and after one month on each diet
Leukocyte adhesion molecules
Measured: before and after one month on each diet
Flow-mediated dilation
Measured: before and after one month on each diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startNov 2004
- Primary completionFeb 2008
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Glenn A Gaesser, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269646
- Sponsor's protocol ID
- HIC11487
- Status last verified
- Feb 2009
- First submitted
- 21 Dec 2005
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-Carbohydrate and High-Carbohydrate, High-Fiber Diet on Insulin Sensitivity and Risk Markers for Cardiovascular Disease in Men and Women With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00269646
- Acronym / sponsor ID
- HIC11487
- Conditions
- Metabolic Syndrome X
- Keywords
- Diet, Low-carbohydrate, Insulin, Dietary fiber, Diabetes, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Aug 2009 (estimated)
- First posted
- 23 Dec 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.
The purpose of this study is to compare the effects of a low-carbohydrate diet and a high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered risk markers for heart disease, in persons with the metabolic syndrome.
Our primary hypothesis is that the ad libitum high-carbohydrate, high-fiber diet will significantly improve insulin sensitivity, whereas the ad libitum low-carbohydrate, low-fiber diet will not.
Detailed description
Low-carbohydrate eating is becoming perceived as more than just a weight loss diet, but rather a means to improve health. Several studies have been published suggesting that low-carbohydrate diets may be preferable to low-fat diets for weight loss and in terms of some health markers. On the other hand, considerable evidence suggests that low-carbohydrate diets, high in fat, are associated with a number of adverse health outcomes. The health benefits of high-carbohydrate, high-fiber diets have also been demonstrated. This study is designed to assess the differences between the two different dietary strategies in terms of a number of health outcomes. Participants will consume, in random order, a non-calorie-restricted low-carbohydrate and a non-calorie-restricted high-carbohydrate, high-fiber diet for one month, with a 4-6 week washout period in between.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1. Subjects must meet the criteria of the metabolic syndrome, which is defined as having three or more of the following:
- Waist circumference: >94 cm for males; >80 cm for females
- Blood Pressure: >130/85 mmHg
- HDL-Chol (mg/dl): <50 women; <40 men)
- Triglycerides (mg/dl): >150
Key exclusion criteria (2 listed)
- 1. Does not meet the criteria for the metabolic syndrome 2. Does not meet age requirement 3. Smoker 4. Pregnancy 5. Food allergies 6. Unwillingness to provide written consent 7. Personal history of cardiovascular disease, including prior myocardial infarction, angioplasty, or bypass surgery 8. Known cardiovascular or metabolic diseases (e.g., diabetes) 9. Currently using medications to control blood pressure, lipids, or glucose 10. Currently on a diet or has attempted weight loss by dieting during the past 3 months 11. Currently taking nutritional supplements other than a daily multivitamin 12. Currently exercising more than the equivalent of 30 minutes/day of moderate-intensity physical activity 13. Currently on oral contraceptives 14. Hematocrit below 40 for men or below 36 for women 15. Baseline systolic blood pressure below 100 mmHg
- -
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 |
|---|---|---|
| Low-carbohydrate and high-carbohydrate dietsEach subject will consume two different ad libitum diets, each for four weeks, with a 4-week washout period inbetween each diet. | Behavioural | – |
Primary outcome
insulin sensitivity
Time frame: before and after one month on each diet
7 secondary outcomes
Total and LDL-cholesterol
Time frame: before and after one month on each diet
C-reactive protein
Time frame: before and after one month on each diet
Homocysteine
Time frame: before and after one month on each diet
Fibrinogen
Time frame: before and after one month on each diet
Cytokines IL-1, IL-2, IL-6 and TNF-alpha
Time frame: before and after one month on each diet
Leukocyte adhesion molecules
Time frame: before and after one month on each diet
Flow-mediated dilation
Time frame: before and after one month on each diet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
Glenn A Gaesser, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-carbohydrate and high-carbohydrate diets in people with Metabolic Syndrome X, run by University of Virginia 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 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2009. 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?
Results are not available in the source record.
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?
insulin sensitivity (time frame: before and after one month on each diet). 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 Feb 2009.