Cardiovascular DiseaseCOMITNCT01233778
Canola Oil Multicentre Intervention Trial (COMIT)
A study testing Canola Oil, High Oleic Acid + DHA Canola Oil and High Oleic Acid Canola Oil in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial summary
The objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Canola Oil, High Oleic Acid + DHA Canola Oil and High Oleic Acid Canola Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2012
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-65 years
- BMI = 22-32 kg/m2
- In addition, eligibility will be based on metabolic syndrome criteria where we define eligibility on the basis of subjects having elevated waist circumference + 1 or more of the remaining 5 criteria:
- Elevated waist circumference - > 102 cm for men and >88 cm for women
- Elevated triglycerides - ≥ 1.7 mmol/L ( ≥150mg/dl) ( no upper limit)
- Reduced HDL - < 1 mmol/L (<40 mg/dl) for men and < 1.3 mmol/L (<50 mg/dl)for women
Show all 10Show fewer
- Fasting glucose - ≥ 100 mg/dl (no upper limit)
- Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG
- Unmedicated participants - upper limit of Stage 1 Hypertension: systolic ≤ 159 and/or diastolic ≤ 99 mm HG and participants must be free of end stage/target organ disease symptoms
- BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of <140/90 mmHg, and have been stable for at least 6 months.
Who cannot join
- Smokers**
- History of thyroid disease, diabetes, kidney or liver disease, heart disease, or other chronic diseases
- Heavy alcohol consumption (>14 drinks/week)
- Chronic anti-inflammatory medication use
- Lactation, pregnancy, or desire to become pregnant during the study
- Taking lipid lowering medications (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil probucol, HMG CoA reductase inhibitors) within the last three months
Show all 9Show fewer
- Not willing to refrain from blood/plasma donation during the study period
- Gall bladder removal
- For purposes of the this study non-smoking is defined as >6 months smoke-free; there is some evidence to show that smoking cessation increases HDL levels and 6 months is adequate time for this to stabilize, however this time span was chosen based on the decreased rate of relapse after 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk
The objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization.
Read the detailed description
The consequence of total fat consumption on circulating plasma lipids and the incidence of cardiovascular disease has long been a central theme in nutrition research. Less well known is the influence of specific fatty acids on vascular endothelial function and the oxidative and inflammatory responses characteristic of atherogenesis. Omega 3 ( ω-3) fatty acids, including plant derived alpha-linolenic acid (18:3n-3, ALA) and marine derived eicosapentaenoic (20:5n-3, EPA) and docosahexaenoic acid (22:6n-3, DHA) have been shown to effectively modulate multiple cardiovascular risk factors in epidemiological, animal model and human clinical investigations. ALA is most commonly consumed as a major component of dietary canola and flaxseed oils and has a recommended intake of 1.1 and 1.6 g/d for women and men, respectively. EPA and DHA are consumed as fatty fish or fish oil and algae supplements with current recommended intakes of 500 mg/d (combined EPA and DHA).
ALA is thought to improve cardiovascular health by modulating circulating lipid concentrations, altering membrane structure and function by enhancing the total ω-3 fatty acid content of cell membrane phospholipids, and reducing inflammatory reactions by blocking the formation of arachidonic acid derived eicosanoids. However, there are extensive knowledge gaps in our understanding of the molecular mechanisms and clinical efficacy of ω-3 fatty acids in human health and disease prevention. Therefore, the purpose of this study is to further examine these relationships.
Feeding protocol and study treatments:
The study will proceed as a double blind, randomized cross-over controlled feeding study. Each treatment phase will be 30 days in duration, separated by 4-week washout periods. Subjects will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate, and 15% protein) supplemented with 60g/d of the following treatment oils: 1) canola oil; 2) DHA enriched canola-oil; 3) high oleic acid canola oil; 4) flax/corn oil (40:60); or 5) safflower/corn oil (75:25). Study diets will be prepared in a metabolic kitchen facility at each clinical site. Three isocaloric meals will be prepared each day for every subject. A 7-day rotating menu cycle will be used. Subjects will consume at least 1 of 3 daily meals under supervision. The other meals will be prepared and packed for every subject to be taken out. The study control and intervention oils will be delivered in milkshakes provided twice daily. Subjects will be instructed to consume only the prepared meals and limit their intake of alcohol to 2 drinks/week and caffeinated calorie free beverages to 40oz (5 drinks) per day. Diets will be planned for every subject according to his/her energy requirements and will be nutritionally adequate.
- Conditions
- Cardiovascular Disease
- Being tested
- Canola Oil, High Oleic Acid + DHA Canola Oil, High Oleic Acid Canola Oil, Flax Oil, Safflower Oil
- Keywords
- Cardiovascular disease, Omega-3 fatty acids, Inflammation, Endothelial function, Canola oil
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canola OilDietary supplement
60g Canola oil daily per 3000kcal diet provided in a supplemental shake
High Oleic Acid + DHA Canola OilDietary supplement
60g high oleic acid canola oil + DHA daily per 3000kcal provided in a supplemental shake
High Oleic Acid Canola OilDietary supplement
60g high oleic acid canola oil daily per 3000kcal provided in a supplemental shake
Flax OilDietary supplement
36g flax oil + 24g safflower oil daily per 3000kcal provided in a supplemental shake
Safflower OilDietary supplement
45g safflower oil + 15g corn oil daily per 3000kcal provided in a supplemental shake
| Study group | Role | What they receive |
|---|---|---|
| Canola Oil | Experimental | Not described Receives: Dietary Supplement: Canola Oil |
| High Oleic Acid Canola + DHA | Experimental | Not described Receives: Dietary Supplement: High Oleic Acid + DHA Canola Oil |
| High Oleic Canola Oil | Experimental | Not described Receives: Dietary Supplement: High Oleic Acid Canola Oil |
| Flax & Safflower Oil (60:40) | Experimental | Not described Receives: Dietary Supplement: Flax Oil |
| Safflower & Corn Oil (75:25) | Experimental | Not described Receives: Dietary Supplement: Safflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Health
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Measured: End of diet period 1 (week 4)
Endothelial Health
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Measured: End of diet period 2 (week 12)
Endothelial Health
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Measured: End of diet period 3 (week 20)
Endothelial Health
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Measured: End of diet period 4 (week 28)
Endothelial Health
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Measured: End of diet period 5 (week 36)
Secondary outcomes (4)
Body Composition
To assess regional changes in body fat deposition, subjects will undergo a dual energy X-ray absorptiometry (DXA) scan at baseline (beginning of study) and end of each intervention period. Waist circumference measurements also will be taken at this time to track how much fat is lost from the abdominal area of the body.
Measured: Week 4, 12, 20, 28 and 36 - End of each diet period
Production of long chain fatty acids
On the 29th day of each diet phase you will be asked to consume three tablespoons of tagged water (known as deuterium). The movement of these tagged materials will allow us to assess the quantity of long chain fatty acids (EPA and DHA) that your body is producing in response to your diet. All of the above tagged materials are non-radioactive, non-toxic, and do not pose any health risk to you. Another fasting blood sample will be obtained when you return the next morning.
Measured: Week 4, 12, 20, 28 and 36 - End of each diet period
Plasma Lipids
Twelve-hour fasting blood samples (30ml) will be collected on day 1, 2, 29 and 30 for analyses of plasma lipids. Blood samples obtained on day 1 and 2 will be used to measure baseline values for study endpoints, whereas blood samples obtained on the two last days will be used to measure final endpoint values.
Measured: Week 4, 12, 20, 28 and 36 - End of each diet period
Plasma Cytokines
Twelve-hour fasting blood samples (30ml) will be collected on day 1, 2, 29 and 30 for analyses of C-reactive protein and inflammatory cytokines. Blood samples obtained on day 1 and 2 will be used to measure baseline values for study endpoints, whereas blood samples obtained on the two last days will be used to measure final endpoint values.
Measured: Week 4, 12, 20, 28 and 36 - End of each diet period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionApr 2012
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.
- More trials run by Penn State 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, RD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233778
- Sponsor's protocol ID
- PKE COMIT
- Acronym
- COMIT
- Status last verified
- Aug 2023
- First submitted
- 1 Nov 2010
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canola and Flax Oils in Modulation of Vascular Function and Biomarkers of Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT01233778
- Acronym / sponsor ID
- COMIT / PKE COMIT
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Omega-3 fatty acids, Inflammation, Endothelial function, Canola oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Nov 2010 (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 objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization.
Detailed description
The consequence of total fat consumption on circulating plasma lipids and the incidence of cardiovascular disease has long been a central theme in nutrition research. Less well known is the influence of specific fatty acids on vascular endothelial function and the oxidative and inflammatory responses characteristic of atherogenesis. Omega 3 ( ω-3) fatty acids, including plant derived alpha-linolenic acid (18:3n-3, ALA) and marine derived eicosapentaenoic (20:5n-3, EPA) and docosahexaenoic acid (22:6n-3, DHA) have been shown to effectively modulate multiple cardiovascular risk factors in epidemiological, animal model and human clinical investigations. ALA is most commonly consumed as a major component of dietary canola and flaxseed oils and has a recommended intake of 1.1 and 1.6 g/d for women and men, respectively. EPA and DHA are consumed as fatty fish or fish oil and algae supplements with current recommended intakes of 500 mg/d (combined EPA and DHA).
ALA is thought to improve cardiovascular health by modulating circulating lipid concentrations, altering membrane structure and function by enhancing the total ω-3 fatty acid content of cell membrane phospholipids, and reducing inflammatory reactions by blocking the formation of arachidonic acid derived eicosanoids. However, there are extensive knowledge gaps in our understanding of the molecular mechanisms and clinical efficacy of ω-3 fatty acids in human health and disease prevention. Therefore, the purpose of this study is to further examine these relationships.
Feeding protocol and study treatments:
The study will proceed as a double blind, randomized cross-over controlled feeding study. Each treatment phase will be 30 days in duration, separated by 4-week washout periods. Subjects will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate, and 15% protein) supplemented with 60g/d of the following treatment oils: 1) canola oil; 2) DHA enriched canola-oil; 3) high oleic acid canola oil; 4) flax/corn oil (40:60); or 5) safflower/corn oil (75:25). Study diets will be prepared in a metabolic kitchen facility at each clinical site. Three isocaloric meals will be prepared each day for every subject. A 7-day rotating menu cycle will be used. Subjects will consume at least 1 of 3 daily meals under supervision. The other meals will be prepared and packed for every subject to be taken out. The study control and intervention oils will be delivered in milkshakes provided twice daily. Subjects will be instructed to consume only the prepared meals and limit their intake of alcohol to 2 drinks/week and caffeinated calorie free beverages to 40oz (5 drinks) per day. Diets will be planned for every subject according to his/her energy requirements and will be nutritionally adequate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Canola Oil | Experimental | Dietary Supplement: Canola Oil |
| High Oleic Acid Canola + DHA | Experimental | Dietary Supplement: High Oleic Acid + DHA Canola Oil |
| High Oleic Canola Oil | Experimental | Dietary Supplement: High Oleic Acid Canola Oil |
| Flax & Safflower Oil (60:40) | Experimental | Dietary Supplement: Flax Oil |
| Safflower & Corn Oil (75:25) | Experimental | Dietary Supplement: Safflower Oil |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 20-65 years
- BMI = 22-32 kg/m2
- In addition, eligibility will be based on metabolic syndrome criteria where we define eligibility on the basis of subjects having elevated waist circumference + 1 or more of the remaining 5 criteria:
- Elevated waist circumference - > 102 cm for men and >88 cm for women
- Elevated triglycerides - ≥ 1.7 mmol/L ( ≥150mg/dl) ( no upper limit)
Key exclusion criteria (9 listed)
- Smokers**
- History of thyroid disease, diabetes, kidney or liver disease, heart disease, or other chronic diseases
- Heavy alcohol consumption (>14 drinks/week)
- Chronic anti-inflammatory medication use
- Lactation, pregnancy, or desire to become pregnant during 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 |
|---|---|---|
| Canola Oil60g Canola oil daily per 3000kcal diet provided in a supplemental shake | Dietary supplement | Canola Oil |
| High Oleic Acid + DHA Canola Oil60g high oleic acid canola oil + DHA daily per 3000kcal provided in a supplemental shake | Dietary supplement | High Oleic Acid Canola + DHA |
| High Oleic Acid Canola Oil60g high oleic acid canola oil daily per 3000kcal provided in a supplemental shake | Dietary supplement | High Oleic Canola Oil |
| Flax Oil36g flax oil + 24g safflower oil daily per 3000kcal provided in a supplemental shake | Dietary supplement | Flax & Safflower Oil (60:40) |
| Safflower Oil45g safflower oil + 15g corn oil daily per 3000kcal provided in a supplemental shake | Dietary supplement | Safflower & Corn Oil (75:25) |
Primary outcome
Endothelial Health
Time frame: End of diet period 1 (week 4)
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Endothelial Health
Time frame: End of diet period 2 (week 12)
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Endothelial Health
Time frame: End of diet period 3 (week 20)
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Endothelial Health
Time frame: End of diet period 4 (week 28)
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
Endothelial Health
Time frame: End of diet period 5 (week 36)
Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.
4 secondary outcomes
Body Composition
Time frame: Week 4, 12, 20, 28 and 36 - End of each diet period
Production of long chain fatty acids
Time frame: Week 4, 12, 20, 28 and 36 - End of each diet period
Plasma Lipids
Time frame: Week 4, 12, 20, 28 and 36 - End of each diet period
Plasma Cytokines
Time frame: Week 4, 12, 20, 28 and 36 - End of each diet period
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 21 Aug 2023.
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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.
Penny M Kris-Etherton, PhD, RD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canola Oil, High Oleic Acid + DHA Canola Oil and High Oleic Acid Canola Oil in people with Cardiovascular Disease, run by Penn State 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 10 inclusion and 9 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 21 Aug 2023. 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?
Endothelial Health (time frame: End of diet period 1 (week 4)). 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 21 Aug 2023.