Other Endothelial DystrophyNCT02153138
The Effect of Plant-based Diets (Vegetarian and Vegan) on Endothelial Function and Atherogenic Parameters
A study testing Endo-pat 2000, carotid intima media thickness Ultrasound and Dexa- Bone densitometer & Bone ultrasonometer System in people with Other Endothelial Dystrophy, run by Tel-Aviv Sourasky Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Endothelial Dystrophy
- What is being tested?
- Endo-pat 2000, carotid intima media thickness Ultrasound and Dexa- Bone densitometer & Bone ultrasonometer System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- over 5 years' adherence to any type of diet
- age range 35-50 years
- BMI ≤32
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- 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.
- Conditions
- Other Endothelial Dystrophy
- Being tested
- Endo-pat 2000, carotid intima media thickness Ultrasound, Dexa- Bone densitometer & Bone ultrasonometer System
- Keywords
- vegetarian diet, vegan, cardiovascular diseases, endothelial function, carotid intima-media thickness
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-pat 2000Device
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
carotid intima media thickness UltrasoundDevice
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.
Dexa- Bone densitometer & Bone ultrasonometer SystemDevice
A means of measuring bone mineral density and body composition by a dual energy X-ray absorptiometry (DEXA) machine
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid intima-media thickness (cIMT)
measure the differences in the thickness of the carotid between the different diet group
Measured: 1 year
Secondary outcomes (1)
body composition
Measure the differences in body composition ( fat %, lean body mass) between the different diet groups
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Endothelial DystrophyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nachum Vaisman, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153138
- Sponsor's protocol ID
- TASMC-14-VN-0085-CTIL
- Status last verified
- May 2014
- First submitted
- 29 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plant-based Diets (Vegetarian and Vegan) on Endothelial Function and Atherogenic Parameters
- ClinicalTrials.gov ID
- NCT02153138
- Acronym / sponsor ID
- TASMC-14-VN-0085-CTIL
- Conditions
- Other Endothelial Dystrophy
- Keywords
- vegetarian diet, vegan, cardiovascular diseases, endothelial function, carotid intima-media thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- over 5 years' adherence to any type of diet
- age range 35-50 years
- BMI ≤32
Key exclusion criteria (7 listed)
- smoking
- type I and II diabetes
- liver and kidney impairments
- cardiovascular diseases
- patients with tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endo-pat 2000The 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 UltrasoundcIMT 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 SystemA means of measuring bone mineral density and body composition by a dual energy X-ray absorptiometry (DEXA) machine | Device | – |
Primary outcome
carotid intima-media thickness (cIMT)
Time frame: 1 year
measure the differences in the thickness of the carotid between the different diet group
1 secondary outcome
body composition
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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Fuchs Endothelial Corneal Dystrophy, Corneal Endothelial Decompensation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nachum Vaisman, MD principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Endo-pat 2000, carotid intima media thickness Ultrasound and Dexa- Bone densitometer & Bone ultrasonometer System in people with Other Endothelial Dystrophy, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, MD (972-524-266-596, nachumv@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid intima-media thickness (cIMT) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.