NCT02153138

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Other Endothelial Dystrophy

Interventions

Type	Name	Description
DEVICE	Endo-pat 2000	The endo peripheral arterial tonometry (PAT) provides an index of endothelial function in two forms: 1. The reactive hyperemia index (RHI) is the post-to-preocclusion PAT signal ratio in the occluded side, normalized to the control side and further corrected for baseline vascular tone. 2. The logarithm RHI (LnRHI) is s similar index as RHI after natural log transformation with a matched cutoff. LnRHI provides better double-sided distribution than RHI and one that is closer to normal distribution
DEVICE	carotid intima media thickness Ultrasound	cIMT is the distance between the intimal-luminal interface and the medial-adventitial interface. It will be studied by B-mode ultrasonography of the extracranial carotid arteries. A duplex system with a 7-10 megahertz (MHz) linear array multi-frequency transducer will be used.
DEVICE	Dexa- Bone densitometer & Bone ultrasonometer System	A means of measuring bone mineral density and body composition by a dual energy X-ray absorptiometry (DEXA) machine

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2014-06-02
• Last updated: 2014-06-02