NCT00324545

Cardiovascular Outcomes Of Diet Counseling

Completed Phase 3 Last updated 21 July 2020

What this trial tests

Phase 3 trial testing Medium-intensity Minimally-directive Counseling in Coronary Artery Disease in 120 participants. Completed in 31 December 2002.

Timeline

1 January 2000

Primary endpoint
31 December 2002

31 December 2002

Quick facts

Lead sponsor	The Camelot Foundation
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	1 January 2000
Primary completion	31 December 2002
Estimated completion	31 December 2002
Sites	2 locations across United States

Drugs / interventions tested

• Medium-intensity Minimally-directive Counseling

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Obesity — all drugs for Obesity →

Sponsor

The Camelot Foundation

Who can join

Adults 30 to 59, any sex, with Coronary Artery Disease or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

(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?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vegan dietary pattern for the primary and secondary prevention of cardiovascular diseases.
   Rees K, Al-Khudairy L, Takeda A, Stranges S. · · 2021 · cited 26× · PMID 33629376 · DOI 10.1002/14651858.cd013501.pub2