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Coronary Artery DiseasePhase 3NCT00324545

Cardiovascular Outcomes Of Diet Counseling

A Phase 3 study testing Medium-intensity Minimally-directive Counseling in people with Coronary Artery Disease and Obesity, run by The Camelot Foundation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they… Read more about this study

Who is it for?
Ages 30 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Coronary Artery Disease, Obesity
What is being tested?
Medium-intensity Minimally-directive Counseling
How many people
120 participants
Where
2 sitesUnited States
Study dates
1 Jan 2000to 31 Dec 2002
Phase
Phase 3
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 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Exclusion criteria: pre-existing co-morbid diseases (documented heart disease, diabetes mellitus, cancer, hypertension, hepatic, renal or gastrointestinal disease), pregnancy or plans for pregnancy. Participants could not be smokers (cigarettes, cigars, pipes or chewing tobacco), take medications (prescription or over the counter medications with the exception of antibiotics), nor take vitamin or mineral supplements. Additionally, they could not currently be on a diet or have been on one during the last 6 months, or have food allergies that would influence food choices.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Keith Block

    Chicago, Illinois, 60201

  • Richard M. Fleming, MD

    Omaha, Nebraska, 68114

Other trials in United States

About this study

Official title: Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Read the detailed description

Given the current epidemic of overweight and obesity on a global scale ("globesity") and the consequent world public health objective of reducing that obesity, it is evident as a practical matter that, the main line of attack must be through diet. The public health objective and the lack of information regarding the long-term public health effects of alternative weight-loss diets motivated this comparative study of the three major types of weight-loss diets and their long term effects on coronary blood flow. Secondary endpoints are inflammatory and other variables associated with heart disease and obesity.

Specifically we asked: (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Being tested
Medium-intensity Minimally-directive Counseling
Keywords
Obesity, Diets, Heart Disease, Randomized controlled trial, Ischemia.
Medical subject headings
Coronary Artery Disease, Obesity, Heart Diseases, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medium-intensity Minimally-directive CounselingBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. coronary blood flow

Secondary outcomes (15)

  1. weight

  2. BMI

  3. LDLc

  4. Total Cholesterol

  5. HDLc

  6. Triglycerides

  7. Homocysteine

  8. Fibrinogen

  9. Lipoprotein (a)

  10. VLDLc

  11. TC/HDL

  12. TG/HDL (Insulin Resistance)

  13. CRP

  14. IL-6

  15. respiratory quotient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2006 (estimated)
  2. Study start1 Jan 2000
  3. Primary completion31 Dec 2002
  4. Study completion31 Dec 2002

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324545
Sponsor's protocol ID
2000-1-1
Status last verified
Jul 2020
First submitted
9 May 2006
Last updated
21 Jul 2020
Results posted
No
Individual data sharing
Yes: Documents we are uploading onto Clinical Trials site.

Publications

  • Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

    PubMed 847061

  • Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. xiii, 617.

  • Bandura, A. (1997). Self-efficacy: The exercise of control. ix, 604.

  • Barnard RJ. Effects of life-style modification on serum lipids. Arch Intern Med. 1991 Jul;151(7):1389-94.

    PubMed 2064490

  • Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996 Aug 28;276(8):637-9. doi: 10.1001/jama.276.8.637. No abstract available.

    PubMed 8773637

  • Cantwell MM, Millen AE, Carroll R, Mittl BL, Hermansen S, Brinton LA, Potischman N. A debriefing session with a nutritionist can improve dietary assessment using food diaries. J Nutr. 2006 Feb;136(2):440-5. doi: 10.1093/jn/136.2.440.

    PubMed 16424125

  • Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.

    PubMed 15632335

  • DAVIS CM. Self regulation of diet in childhood. Health Educ J (Los Angel). 1947 Jan;5:37-40. doi: 10.1177/001789694700500110. No abstract available.

    PubMed 20247154

  • Fleming, R. M. (1999). The pathogenesis of vascular disease. In J. Chang (Ed.), The Textbook of Angiology (pp. 787-798). New York: Springer-Verlag.

  • Fleming RM. The effect of high-protein diets on coronary blood flow. Angiology. 2000 Oct;51(10):817-26. doi: 10.1177/000331970005101003.

    PubMed 11108325

  • Fleming RM. Reversing heart disease in the new millennium--the Fleming unified theory. Angiology. 2000 Aug;51(8):617-29.

    PubMed 10959514

  • Fleming RM. The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors. Prev Cardiol. 2002 Summer;5(3):110-8. doi: 10.1111/j.1520-037x.2002.01231.x.

    PubMed 12091753

  • Fleming RM, Ketchum K, Fleming DM, Gaede R. Treating hyperlipidemia in the elderly. Angiology. 1995 Dec;46(12):1075-83. doi: 10.1177/000331979504601202.

    PubMed 7495312

  • Fleming RM, Ketchum K, Fleming DM, Gaede R. Assessing the independent effect of dietary counseling and hypolipidemic medications on serum lipids. Angiology. 1996 Sep;47(9):831-40. doi: 10.1177/000331979604700901.

    PubMed 8810649

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Medium-intensity Minimally-directive Counseling in people with Coronary Artery Disease and Obesity, run by The Camelot Foundation at 2 sites 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 1 inclusion and 0 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 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

coronary blood flow. 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 NCT00324545, which also lists 14 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 21 Jul 2020.

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