The Effect of Plant-based Diets (Vegetarian and Vegan) on Endothelial Function and Atherogenic Parameters
- Conditions
- Other Endothelial Dystrophy
- Registration Number
- NCT02153138
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
The investigators' hypothesis is that a plant-based diet may be beneficial if nutritional deficiencies will be corrected. The aims of the present proposal are to 1) study endothelial functions of subjects on well-defined vegetarian/vegan diets compared to age and sex matched omnivores (controls), and 2) study the differences in energy expenditure, body composition, overnight substrate utilization, blood work results, and levels of intracellular reactive oxygen species (ROS) and of adhesion molecules on the different diets.
- Detailed Description
The serious doubts about the nutritional adequacy of vegetarian diets in the past were essentially put to rest by recent studies that suggested that plant-based diets are healthy and associated with lower risk of several chronic diseases. Nevertheless, various nutritional deficiencies have been identified, and it has been shown that individuals who follow different types of vegetarian/vegan diets may not experience the same effects on their health.
Working Hypothesis
1. Vegetarian/vegan diets will promote protection against cardiovascular risk factors if supplemented with possibly deficient nutrients.
2. There will a further protective effect and a greater number of differences between subjects following a vegetarian diet compared to those following a vegan diet.
3. Higher energy expenditure and lower and different caloric intake will promote a favorable difference in body composition (lower body fat) via a different substrate utilization expressed in the measured respiratory quotient (RQ).
4. Extra- and intracellular free radicals will be higher in subjects who adhere to vegetarian/vegan diets compared to omnivores.
Aims of the study
1. To study the effect of vegetarian/vegan diets on endothelial functions after correcting for modifying factors.
2. To study the effect of the above-mentioned plant-based diets on carotid intima-media thickness.
3. To study the differences in body composition, resting energy expenditure and over-night substrate utilization between the different diets.
4. To study the intracellular ROS of subjects following different diets.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- over 5 years' adherence to any type of diet
- age range 35-50 years
- BMI ≤32
- smoking
- type I and II diabetes
- liver and kidney impairments
- cardiovascular diseases
- patients with tumors
- patients on medications which may affect cardiovascular parameters (including 5 phosphodiesterase inhibitors, beta blockers, ACE inhibitors and others)
- BMI >32 kg/m2.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method carotid intima-media thickness (cIMT) 1 year measure the differences in the thickness of the carotid between the different diet group
- Secondary Outcome Measures
Name Time Method body composition 1-year Measure the differences in body composition ( fat %, lean body mass) between the different diet groups