The Effect of Plant-based Diets (Vegetarian and Vegan) on Endothelial Function and Atherogenic Parameters
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|ClinicalTrials.gov Identifier: NCT02153138|
Recruitment Status : Unknown
Verified May 2014 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Other Endothelial Dystrophy||Device: Endo-pat 2000 Device: carotid intima media thickness Ultrasound Device: Dexa- Bone densitometer & Bone ultrasonometer System||Not Applicable|
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.
- Vegetarian/vegan diets will promote protection against cardiovascular risk factors if supplemented with possibly deficient nutrients.
- 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.
- 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).
- Extra- and intracellular free radicals will be higher in subjects who adhere to vegetarian/vegan diets compared to omnivores.
Aims of the study
- To study the effect of vegetarian/vegan diets on endothelial functions after correcting for modifying factors.
- To study the effect of the above-mentioned plant-based diets on carotid intima-media thickness.
- To study the differences in body composition, resting energy expenditure and over-night substrate utilization between the different diets.
- To study the intracellular ROS of subjects following different diets.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||September 2015|
- Device: Endo-pat 2000
The endo peripheral arterial tonometry (PAT) provides an index of endothelial function in two forms:
- 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.
- 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
- carotid intima-media thickness (cIMT) [ Time Frame: 1 year ]measure the differences in the thickness of the carotid between the different diet group
- body composition [ Time Frame: 1-year ]Measure the differences in body composition ( fat %, lean body mass) between the different diet groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153138
|Contact: Nachum Vaisman, MDfirstname.lastname@example.org|
|Principal Investigator:||Nachum Vaisman, MD||Tel-Aviv Sourasky Medical Center|