跳至主要内容
临床试验/NCT00324545
NCT00324545已完成3 期

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

The Camelot Foundation4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2000年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
120
试验地点
4
主要终点
coronary blood flow

研究概览

简要总结

(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?

详细描述

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?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI greater than 30,

排除标准

  • 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.

结局指标

主要结局

coronary blood flow

次要结局

  • Total Cholesterol
  • HDLc
  • VLDLc
  • weight
  • Fibrinogen
  • BMI
  • LDLc
  • Triglycerides
  • TG/HDL (Insulin Resistance)
  • CRP
  • Homocysteine
  • Lipoprotein (a)
  • respiratory quotient
  • TC/HDL
  • IL-6

研究者

发起方
The Camelot Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

RM Fleming, MD

PI

The Camelot Foundation

研究点 (4)

Loading locations...

相似试验