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

May 30, 2014 updated by: Tel-Aviv Sourasky Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 5 years' adherence to any type of diet
  • age range 35-50 years
  • BMI ≤32

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
carotid intima-media thickness (cIMT)
Time Frame: 1 year
measure the differences in the thickness of the carotid between the different diet group
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition
Time Frame: 1-year
Measure the differences in body composition ( fat %, lean body mass) between the different diet groups
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Nachum Vaisman, MD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-14-VN-0085-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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