Coronary Artery DiseaseNCT01887093
The Influence of Walking at Different Times of Day on Blood Lipids and Inflammatory Markers
A study testing walking in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
It has been well known that moderate and regular levels of physical activity has a favorable effect on many of the established risk factors related to coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Mar 2013
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients were younger than 80 years;
- They had been diagnosed with coronary artery disease by coronary angiography (at least 1 main coronary artery having >50% luminal diameter stenosis);
- They were able to walk but had a sedentary lifestyle which was defined as no regular physical activity in excess of 30 min/day, for more than 3 days/week over the last 3 months.
Who cannot join
- valvular heart disease;
- atrial fibrillation;
- cardiomyopathy;
- myocarditis;
- uncontrolled chronic diseases;
- congestive heart failure or ejection fraction <50% by echocardiogram.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: The Influence of Regular Walking at Different Times of Day on Blood Lipids and Inflammatory Markers in Sedentary Patients With Coronary Artery Disease
It has been well known that moderate and regular levels of physical activity has a favorable effect on many of the established risk factors related to coronary artery disease (CAD). Given that exercise in the morning has a greater potential for inducing sudden cardiac death and myocardial ischemia, it may be sensible for patients with CAD not to take exercise at this time. Our previous study indicated that the protective effect of exercise in the evening was greater than morning. However, which times of day to exercise could achieve the greatest improvements in lipids and inflammatory markers remains unclear. The purpose of the present study was to investigate the responses of lipid profiles and inflammatory markers to walking at different times of day in sedentary patients with CAD.
Read the detailed description
According to the inclusion and exclusion criteria, 330 patients with CAD between the ages of 40 and 80 years were recruited from the inpatient cardiology department of the First Affiliated Hospital of Nanjing Medical University. Informed consent was obtained from each participant after explaining the study protocols. Patients were randomly assigned to one of the three groups: control group (n=110), morning walking group (n=110) or evening walking group (n=110). The control group was requested to maintain their usual level of physical activity. Participants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. The protocol of exercise was identical, while the difference between the two groups was that one group was asked for walking in the morning and the other group walking in the evening. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to understand the information about walking and medication use. In the intervention groups, subjects whose compliance rate with their respectively walking program were less than 85% were excluded in the analysis. Additionally, all the participants were given an advice on quitting smoking and were provided with similar diets by a nutritionist, as to caloric intake and nutrients. Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, lipoprotein a, white blood cell count and platelet count, fibrinogen were measured before and after the intervention.
The Kolmogorov-Smirnov test was used to check the normal distribution of all continuous variables. The values of normal distribution were expressed as mean±SD, and non-normal distribution data were presented as median (interquartile range). Baseline differences between groups were determined by one-way analysis of variance and chi-square analyses. Baseline and follow-up values within each group were compared using the paired t test. General linear models were used to adjust the differences in baseline values for dependent variables. And two-way ANOVA was used for determination of the improvements of lipids and inflammatory markers in three groups. The significance level was defined as P<0.05. All analyses were carried out using SPSS version 13.
- Conditions
- Coronary Artery Disease
- Being tested
- walking
- Keywords
- coronary artery disease, walking, lipids, inflammatory markers, time of day
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walkingBehavioural
Participants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks.One group was asked to walk in the morning and the other group was asked to walk in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Morning walking | Experimental | Participants were requested to walk in the morning at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded. Receives: Behavioral: walking |
| Evening walking | Experimental | Participants were requested to walk in the evening at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded. Receives: Behavioral: walking |
| No walking | No intervention | The control group was requested to maintain their usual level of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipids and inflammatory markers
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol,low-density lipoprotein cholesterol, lipoprotein a;inflammatory markers include white blood cell count, platelet count, fibrinogen
Measured: 12 weeks
Secondary outcomes (1)
Blood lipids and inflammatory markers
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein, lipoprotein a; inflammatory markers include white blood cell count, platelet count, fibrinogen
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Qing Lian, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiao-Qing Lian, Master, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887093
- Sponsor's protocol ID
- NSFC(No. 81270255)
- Other IDs
- 81270255
- Status last verified
- Jun 2013
- First submitted
- 22 Jun 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.
PubMed 17671237Boardley D, Fahlman M, Topp R, Morgan AL, McNevin N. The impact of exercise training on blood lipids in older adults. Am J Geriatr Cardiol. 2007 Jan-Feb;16(1):30-5. doi: 10.1111/j.1076-7460.2007.05353.x.
PubMed 17215640Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.
PubMed 10993420Andreotti F, Davies GJ, Hackett DR, Khan MI, De Bart AC, Aber VR, Maseri A, Kluft C. Major circadian fluctuations in fibrinolytic factors and possible relevance to time of onset of myocardial infarction, sudden cardiac death and stroke. Am J Cardiol. 1988 Sep 15;62(9):635-7. doi: 10.1016/0002-9149(88)90669-8. No abstract available.
PubMed 3137799Elherik K, Khan F, McLaren M, Kennedy G, Belch JJ. Circadian variation in vascular tone and endothelial cell function in normal males. Clin Sci (Lond). 2002 May;102(5):547-52.
PubMed 11980574Fahlman MM, Boardley D, Lambert CP, Flynn MG. Effects of endurance training and resistance training on plasma lipoprotein profiles in elderly women. J Gerontol A Biol Sci Med Sci. 2002 Feb;57(2):B54-60. doi: 10.1093/gerona/57.2.b54.
PubMed 11818424Geffken DF, Cushman M, Burke GL, Polak JF, Sakkinen PA, Tracy RP. Association between physical activity and markers of inflammation in a healthy elderly population. Am J Epidemiol. 2001 Feb 1;153(3):242-50. doi: 10.1093/aje/153.3.242.
PubMed 11157411Jahangard T, Torkaman G, Ghoosheh B, Hedayati M, Dibaj A. The effect of short-term aerobic training on coagulation and fibrinolytic factors in sedentary healthy postmenopausal women. Maturitas. 2009 Dec 20;64(4):223-7. doi: 10.1016/j.maturitas.2009.09.003. Epub 2009 Oct 24.
PubMed 19854593Jones H, Pritchard C, George K, Edwards B, Atkinson G. The acute post-exercise response of blood pressure varies with time of day. Eur J Appl Physiol. 2008 Oct;104(3):481-9. doi: 10.1007/s00421-008-0797-4. Epub 2008 Jun 20.
PubMed 18566827Kanaley JA, Weltman JY, Pieper KS, Weltman A, Hartman ML. Cortisol and growth hormone responses to exercise at different times of day. J Clin Endocrinol Metab. 2001 Jun;86(6):2881-9. doi: 10.1210/jcem.86.6.7566.
PubMed 11397904Kelley GA, Kelley KS, Tran ZV. Walking, lipids, and lipoproteins: a meta-analysis of randomized controlled trials. Prev Med. 2004 May;38(5):651-61. doi: 10.1016/j.ypmed.2003.12.012.
PubMed 15066369Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.
PubMed 12421890Lee CD, Folsom AR, Nieto FJ, Chambless LE, Shahar E, Wolfe DA. White blood cell count and incidence of coronary heart disease and ischemic stroke and mortality from cardiovascular disease in African-American and White men and women: atherosclerosis risk in communities study. Am J Epidemiol. 2001 Oct 15;154(8):758-64. doi: 10.1093/aje/154.8.758.
PubMed 11590089Lippi G, Franchini M, Salvagno GL, Montagnana M, Guidi GC. Higher morning serum cortisol level predicts increased fibrinogen but not shortened APTT. J Thromb Thrombolysis. 2008 Oct;26(2):103-5. doi: 10.1007/s11239-007-0074-0. Epub 2007 Jul 13.
PubMed 17629773Maresca G, Di Blasio A, Marchioli R, Di Minno G. Measuring plasma fibrinogen to predict stroke and myocardial infarction: an update. Arterioscler Thromb Vasc Biol. 1999 Jun;19(6):1368-77. doi: 10.1161/01.atv.19.6.1368.
PubMed 10364066
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Regular Walking at Different Times of Day on Blood Lipids and Inflammatory Markers in Sedentary Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01887093
- Acronym / sponsor ID
- NSFC(No. 81270255)
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, walking, lipids, inflammatory markers, time of day
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Jun 2013 (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.
It has been well known that moderate and regular levels of physical activity has a favorable effect on many of the established risk factors related to coronary artery disease (CAD). Given that exercise in the morning has a greater potential for inducing sudden cardiac death and myocardial ischemia, it may be sensible for patients with CAD not to take exercise at this time. Our previous study indicated that the protective effect of exercise in the evening was greater than morning. However, which times of day to exercise could achieve the greatest improvements in lipids and inflammatory markers remains unclear. The purpose of the present study was to investigate the responses of lipid profiles and inflammatory markers to walking at different times of day in sedentary patients with CAD.
Detailed description
According to the inclusion and exclusion criteria, 330 patients with CAD between the ages of 40 and 80 years were recruited from the inpatient cardiology department of the First Affiliated Hospital of Nanjing Medical University. Informed consent was obtained from each participant after explaining the study protocols. Patients were randomly assigned to one of the three groups: control group (n=110), morning walking group (n=110) or evening walking group (n=110). The control group was requested to maintain their usual level of physical activity. Participants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. The protocol of exercise was identical, while the difference between the two groups was that one group was asked for walking in the morning and the other group walking in the evening. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to understand the information about walking and medication use. In the intervention groups, subjects whose compliance rate with their respectively walking program were less than 85% were excluded in the analysis. Additionally, all the participants were given an advice on quitting smoking and were provided with similar diets by a nutritionist, as to caloric intake and nutrients. Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, lipoprotein a, white blood cell count and platelet count, fibrinogen were measured before and after the intervention.
The Kolmogorov-Smirnov test was used to check the normal distribution of all continuous variables. The values of normal distribution were expressed as mean±SD, and non-normal distribution data were presented as median (interquartile range). Baseline differences between groups were determined by one-way analysis of variance and chi-square analyses. Baseline and follow-up values within each group were compared using the paired t test. General linear models were used to adjust the differences in baseline values for dependent variables. And two-way ANOVA was used for determination of the improvements of lipids and inflammatory markers in three groups. The significance level was defined as P<0.05. All analyses were carried out using SPSS version 13.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morning walking | Experimental | Behavioral: walkingParticipants were requested to walk in the morning at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded. |
| Evening walking | Experimental | Behavioral: walkingParticipants were requested to walk in the evening at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded. |
| No walking | No intervention | –The control group was requested to maintain their usual level of physical activity. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients were younger than 80 years;
- They had been diagnosed with coronary artery disease by coronary angiography (at least 1 main coronary artery having >50% luminal diameter stenosis);
- They were able to walk but had a sedentary lifestyle which was defined as no regular physical activity in excess of 30 min/day, for more than 3 days/week over the last 3 months.
Key exclusion criteria (6 listed)
- valvular heart disease;
- atrial fibrillation;
- cardiomyopathy;
- myocarditis;
- uncontrolled chronic diseases;
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 |
|---|---|---|
| walkingParticipants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks.One group was asked to walk in the morning and the other group was asked to walk in the evening. | Behavioural | Evening walking, Morning walking |
Primary outcome
Blood lipids and inflammatory markers
Time frame: 12 weeks
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol,low-density lipoprotein cholesterol, lipoprotein a;inflammatory markers include white blood cell count, platelet count, fibrinogen
1 secondary outcome
Blood lipids and inflammatory markers
Time frame: 24 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 27 Jun 2013.
- Background: PubMed 17671237Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.
- Background: PubMed 17215640Boardley D, Fahlman M, Topp R, Morgan AL, McNevin N. The impact of exercise training on blood lipids in older adults. Am J Geriatr Cardiol. 2007 Jan-Feb;16(1):30-5. doi: 10.1111/j.1076-7460.2007.05353.x.
- Background: PubMed 10993420Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.
- Background: PubMed 3137799Andreotti F, Davies GJ, Hackett DR, Khan MI, De Bart AC, Aber VR, Maseri A, Kluft C. Major circadian fluctuations in fibrinolytic factors and possible relevance to time of onset of myocardial infarction, sudden cardiac death and stroke. Am J Cardiol. 1988 Sep 15;62(9):635-7. doi: 10.1016/0002-9149(88)90669-8. No abstract available.
- Background: PubMed 11980574Elherik K, Khan F, McLaren M, Kennedy G, Belch JJ. Circadian variation in vascular tone and endothelial cell function in normal males. Clin Sci (Lond). 2002 May;102(5):547-52.
- Background: PubMed 11818424Fahlman MM, Boardley D, Lambert CP, Flynn MG. Effects of endurance training and resistance training on plasma lipoprotein profiles in elderly women. J Gerontol A Biol Sci Med Sci. 2002 Feb;57(2):B54-60. doi: 10.1093/gerona/57.2.b54.
- Background: PubMed 11157411Geffken DF, Cushman M, Burke GL, Polak JF, Sakkinen PA, Tracy RP. Association between physical activity and markers of inflammation in a healthy elderly population. Am J Epidemiol. 2001 Feb 1;153(3):242-50. doi: 10.1093/aje/153.3.242.
- Background: PubMed 19854593Jahangard T, Torkaman G, Ghoosheh B, Hedayati M, Dibaj A. The effect of short-term aerobic training on coagulation and fibrinolytic factors in sedentary healthy postmenopausal women. Maturitas. 2009 Dec 20;64(4):223-7. doi: 10.1016/j.maturitas.2009.09.003. Epub 2009 Oct 24.
- Background: PubMed 18566827Jones H, Pritchard C, George K, Edwards B, Atkinson G. The acute post-exercise response of blood pressure varies with time of day. Eur J Appl Physiol. 2008 Oct;104(3):481-9. doi: 10.1007/s00421-008-0797-4. Epub 2008 Jun 20.
- Background: PubMed 11397904Kanaley JA, Weltman JY, Pieper KS, Weltman A, Hartman ML. Cortisol and growth hormone responses to exercise at different times of day. J Clin Endocrinol Metab. 2001 Jun;86(6):2881-9. doi: 10.1210/jcem.86.6.7566.
- Background: PubMed 15066369Kelley GA, Kelley KS, Tran ZV. Walking, lipids, and lipoproteins: a meta-analysis of randomized controlled trials. Prev Med. 2004 May;38(5):651-61. doi: 10.1016/j.ypmed.2003.12.012.
- Background: PubMed 12421890Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.
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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.
Xiao-Qing Lian, Master principal investigator
The First Affiliated Hospital with Nanjing Medical 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 walking in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 3 inclusion and 6 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 27 Jun 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 China. 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?
Blood lipids and inflammatory markers (time frame: 12 weeks). 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 NCT01887093, which also lists 16 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 27 Jun 2013.