Coronary Artery DiseaseTTM in CADNCT00810992
Traditional Tibetan Medicine for Patients With Coronary Artery Disease
A study testing Nutritional and behavioral program A and Nutritional and behavioral program B in people with Coronary Artery Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Coronary artery disease has a high death toll in the Western world. Changes in lifestyle, particularly in nutrition and physical activity may significantly reduce a severe coronary atherosclerosis within one year without the use of medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Nutritional and behavioral program A and Nutritional and behavioral program B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years old
- male and female
- coronary artery disease
- criteria of International Diabetes Federation (IDF)
Who cannot join
- <18 years old
- incapability for informed consent
- history of malignity, psychiatric disorder, tissue, thyroid gland and renal diseases, anorexia or bulimia
- administration of steroids or hormones
- pregnancy
- body mass index < 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol
Coronary artery disease has a high death toll in the Western world. Changes in lifestyle, particularly in nutrition and physical activity may significantly reduce a severe coronary atherosclerosis within one year without the use of medication. Several dietary studies have shown that not only the progress of coronary artery disease can be slowed down, but it may also increase significantly the survival of these patients.
Up until now there is little known about therapeutic effects by complementary medicine. In particular, Traditional Tibetan medicine dietary programs have shown in few case reports that weight could be reduced in patients with obesity.
Therefore, the investigators developed a specific dietary program for patients with coronary artery disease, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF).
- Conditions
- Coronary Artery Disease
- Being tested
- Nutritional and behavioral program A, Nutritional and behavioral program B
- Keywords
- dietary, behavior, IDF criteria, coronary artery disease, Traditional Tibetan Medicine, coronary artery disease in patients, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF)
- Medical subject headings
- Coronary Artery Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and behavioral program ABehavioural
Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease
Nutritional and behavioral program BBehavioural
Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine
| Study group | Role | What they receive |
|---|---|---|
| 1 Program A | Active comparator | Recommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease Receives: Behavioral: Nutritional and behavioral program A |
| 2 Program B | Experimental | Recommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine Receives: Behavioral: Nutritional and behavioral program B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 6 months
Secondary outcomes (1)
Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 University Hospital TuebingenThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Bigalke, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810992
- Sponsor's protocol ID
- 337/2008BO1 UKT
- Acronym
- TTM in CAD
- Status last verified
- Jan 2013
- First submitted
- 17 Dec 2008
- Last updated
- 14 Jan 2013
- Results posted
- No
Publications
Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
PubMed 1973470Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61. doi: 10.1016/S0140-6736(02)11472-3.
PubMed 12433513Michels KB, Wolk A. A prospective study of variety of healthy foods and mortality in women. Int J Epidemiol. 2002 Aug;31(4):847-54. doi: 10.1093/ije/31.4.847.
PubMed 12177033Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival in a Greek population. N Engl J Med. 2003 Jun 26;348(26):2599-608. doi: 10.1056/NEJMoa025039.
PubMed 12826634Bigalke B, Geisler T, Stellos K, Langer H, Daub K, Kremmer E, Seizer P, May AE, Lindemann S, Gawaz M. Platelet collagen receptor glycoprotein VI as a possible novel indicator for the acute coronary syndrome. Am Heart J. 2008 Jul;156(1):193-200. doi: 10.1016/j.ahj.2008.02.010. Epub 2008 Apr 23.
PubMed 18585516Bigalke B, Lindemann S, Ehlers R, Seizer P, Daub K, Langer H, Schonberger T, Kremmer E, Siegel-Axel D, May AE, Gawaz M. Expression of platelet collagen receptor glycoprotein VI is associated with acute coronary syndrome. Eur Heart J. 2006 Sep;27(18):2165-9. doi: 10.1093/eurheartj/ehl192. Epub 2006 Aug 21.
PubMed 16923742Liu L, Liu L, Ding Y, Huang Z, He B, Sun S, Zhao G, Zhang H, Miki T, Mizushima S, Ikeda K, Nara Y, Yamori Y. Ethnic and environmental differences in various markers of dietary intake and blood pressure among Chinese Han and three other minority peoples of China: results from the WHO Cardiovascular Diseases and Alimentary Comparison (CARDIAC) Study. Hypertens Res. 2001 May;24(3):315-22. doi: 10.1291/hypres.24.315.
PubMed 11409657von Haehling S, Stellos K, Qusar N, Gawaz M, Bigalke B. Weight reduction in patients with coronary artery disease: comparison of Traditional Tibetan Medicine and Western diet. Int J Cardiol. 2013 Sep 30;168(2):1509-15. doi: 10.1016/j.ijcard.2013.07.034. Epub 2013 Jul 26.
PubMed 23890855
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Nutritional Therapy in Patients With Coronary Artery Disease According to Traditional Tibetan Medicine Protocol
- ClinicalTrials.gov ID
- NCT00810992
- Acronym / sponsor ID
- TTM in CAD / 337/2008BO1 UKT
- Conditions
- Coronary Artery Disease
- Keywords
- dietary, behavior, IDF criteria, coronary artery disease, Traditional Tibetan Medicine, coronary artery disease in patients, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Dec 2008 (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.
Coronary artery disease has a high death toll in the Western world. Changes in lifestyle, particularly in nutrition and physical activity may significantly reduce a severe coronary atherosclerosis within one year without the use of medication. Several dietary studies have shown that not only the progress of coronary artery disease can be slowed down, but it may also increase significantly the survival of these patients.
Up until now there is little known about therapeutic effects by complementary medicine. In particular, Traditional Tibetan medicine dietary programs have shown in few case reports that weight could be reduced in patients with obesity.
Therefore, the investigators developed a specific dietary program for patients with coronary artery disease, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Program A | Active comparator | Behavioral: Nutritional and behavioral program ARecommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease |
| 2 Program B | Experimental | Behavioral: Nutritional and behavioral program BRecommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 18 years old
- male and female
- coronary artery disease
- criteria of International Diabetes Federation (IDF)
Key exclusion criteria (6 listed)
- <18 years old
- incapability for informed consent
- history of malignity, psychiatric disorder, tissue, thyroid gland and renal diseases, anorexia or bulimia
- administration of steroids or hormones
- pregnancy
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 |
|---|---|---|
| Nutritional and behavioral program ARecommendation for nutrition and behavior for patients with coronary artery disease according to the German Society of Nutritional Medicine and the International Task Force for the Prevention of Coronary Artery Disease | Behavioural | 1 Program A |
| Nutritional and behavioral program BRecommendation for nutrition and behavior for patients with coronary artery disease according to the system of the Traditional Tibetan Medicine | Behavioural | 2 Program B |
Primary outcome
Body mass index
Time frame: 6 months
1 secondary outcome
Intima media thickness HbA1C Lipid status Platelet activation markers as prognostic biomarkers
Time frame: 6 months
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 14 Jan 2013.
- Background: PubMed 1973470Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.
- Background: PubMed 12433513Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61. doi: 10.1016/S0140-6736(02)11472-3.
- Background: PubMed 12177033Michels KB, Wolk A. A prospective study of variety of healthy foods and mortality in women. Int J Epidemiol. 2002 Aug;31(4):847-54. doi: 10.1093/ije/31.4.847.
- Background: PubMed 12826634Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. Adherence to a Mediterranean diet and survival in a Greek population. N Engl J Med. 2003 Jun 26;348(26):2599-608. doi: 10.1056/NEJMoa025039.
- Background: PubMed 18585516Bigalke B, Geisler T, Stellos K, Langer H, Daub K, Kremmer E, Seizer P, May AE, Lindemann S, Gawaz M. Platelet collagen receptor glycoprotein VI as a possible novel indicator for the acute coronary syndrome. Am Heart J. 2008 Jul;156(1):193-200. doi: 10.1016/j.ahj.2008.02.010. Epub 2008 Apr 23.
- Background: PubMed 16923742Bigalke B, Lindemann S, Ehlers R, Seizer P, Daub K, Langer H, Schonberger T, Kremmer E, Siegel-Axel D, May AE, Gawaz M. Expression of platelet collagen receptor glycoprotein VI is associated with acute coronary syndrome. Eur Heart J. 2006 Sep;27(18):2165-9. doi: 10.1093/eurheartj/ehl192. Epub 2006 Aug 21.
- Results publication: PubMed 11409657Liu L, Liu L, Ding Y, Huang Z, He B, Sun S, Zhao G, Zhang H, Miki T, Mizushima S, Ikeda K, Nara Y, Yamori Y. Ethnic and environmental differences in various markers of dietary intake and blood pressure among Chinese Han and three other minority peoples of China: results from the WHO Cardiovascular Diseases and Alimentary Comparison (CARDIAC) Study. Hypertens Res. 2001 May;24(3):315-22. doi: 10.1291/hypres.24.315.
- Derived from this study: PubMed 23890855von Haehling S, Stellos K, Qusar N, Gawaz M, Bigalke B. Weight reduction in patients with coronary artery disease: comparison of Traditional Tibetan Medicine and Western diet. Int J Cardiol. 2013 Sep 30;168(2):1509-15. doi: 10.1016/j.ijcard.2013.07.034. Epub 2013 Jul 26.
- German Society of Nutritional MedicineLink provided by the sponsor.
- International Task Force for Prevention of Coronary Heart DiseaseLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and behavioral program A and Nutritional and behavioral program B in people with Coronary Artery Disease, run by University Hospital Tuebingen at 1 site in Germany.
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 4 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 14 Jan 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 Germany. 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?
Body mass index (time frame: 6 months). 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 NCT00810992, which also lists 8 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 14 Jan 2013.