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Clinical Trials/NCT02153138
NCT02153138
Unknown
Not Applicable

The Effect of Plant-based Diets (Vegetarian and Vegan) on Endothelial Function and Atherogenic Parameters

Tel-Aviv Sourasky Medical Center0 sites150 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Other Endothelial Dystrophy
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
150
Primary Endpoint
carotid intima-media thickness (cIMT)
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
September 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • over 5 years' adherence to any type of diet
  • age range 35-50 years

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

carotid intima-media thickness (cIMT)

Time Frame: 1 year

measure the differences in the thickness of the carotid between the different diet group

Secondary Outcomes

  • body composition(1-year)

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