Vegan DietNCT02336295
Developing and Validating a Food Frequency Questionnaires (FFQ) for the Vegan Population in Israel
A study testing Food Frequency Questionnaires in people with Vegan Diet, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the vegan population in Israel. The participants will complete the FFQ, and the data will be verified by evaluating the participants energy expenditure (by measuring BMR, body composition and daily activity) and conducting a… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vegan Diet
- What is being tested?
- Food Frequency Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2015to Jan 2016
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- consumption of beef, chicken, fish, eggs, milk or dairy is no more than once a month, for the last 6 months
- age 18-40
Who cannot join
- consumption of beef, chicken, fish, eggs, milk or dairy more than once a month
- chronic conditions (such as diabetes, hypertension, cardiovascular disease)
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the vegan population in Israel. The participants will complete the FFQ, and the data will be verified by evaluating the participants energy expenditure (by measuring BMR, body composition and daily activity) and conducting a 24-hour food interview.
- Conditions
- Vegan Diet
- Being tested
- Food Frequency Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Frequency QuestionnairesOther
filling a Food Frequency Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Food Frequency Questionnaires | Other | Filling out a Food Frequency Questionnaires (FFQ) Receives: Other: Food Frequency Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily energy consumption (Kcal/Day)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vegan DietStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336295
- Sponsor's protocol ID
- 0469-14-TLV
- Status last verified
- Jan 2015
- First submitted
- 1 Jan 2015
- Last updated
- 12 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating a Food Frequency Questionnaires (FFQ) for the Vegan Population in Israel
- ClinicalTrials.gov ID
- NCT02336295
- Acronym / sponsor ID
- 0469-14-TLV
- Conditions
- Vegan Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 12 Jan 2015 (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 study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the vegan population in Israel. The participants will complete the FFQ, and the data will be verified by evaluating the participants energy expenditure (by measuring BMR, body composition and daily activity) and conducting a 24-hour food interview.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food Frequency Questionnaires | Other | Other: Food Frequency QuestionnairesFilling out a Food Frequency Questionnaires (FFQ) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- consumption of beef, chicken, fish, eggs, milk or dairy is no more than once a month, for the last 6 months
- age 18-40
Key exclusion criteria (2 listed)
- consumption of beef, chicken, fish, eggs, milk or dairy more than once a month
- chronic conditions (such as diabetes, hypertension, cardiovascular disease)
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 |
|---|---|---|
| Food Frequency Questionnairesfilling a Food Frequency Questionnaires | Other | Food Frequency Questionnaires |
Primary outcome
Daily energy consumption (Kcal/Day)
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Frequency Questionnaires in people with Vegan Diet, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily energy consumption (Kcal/Day) (time frame: 24 hour). 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 12 Jan 2015.