HealthyNCT03409445
Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake
An observational study of Healthy, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial summary
As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 152 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2018to 25 Jul 2018
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- healthy males and females aged 18 to 60
Who cannot join
- known disorders of the gastrointestinal tract which can lead to malabsorption
- intake of medication which could affect the absorption of any nutrients
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Food Frequency Questionnaire for the Assessment of Omega-3
As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.
- Conditions
- Healthy
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention (observational study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid composition of red blood cells due to dietary habits
Fatty acid composition of red blood cells due to dietary habits
Measured: 1 day ( first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start15 Jan 2018
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409445
- Sponsor's protocol ID
- N3FFQ
- Status last verified
- Jul 2018
- First submitted
- 18 Jan 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Food Frequency Questionnaire for the Assessment of Omega-3
- ClinicalTrials.gov ID
- NCT03409445
- Acronym / sponsor ID
- N3FFQ
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 24 Jan 2018 (actual)
- 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.
As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (1 listed)
- healthy males and females aged 18 to 60
Key exclusion criteria (3 listed)
- known disorders of the gastrointestinal tract which can lead to malabsorption
- intake of medication which could affect the absorption of any nutrients
- Pregnant or breast-feeding women
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 |
|---|---|---|
| no interventionno intervention (observational study) | Other | – |
Primary outcome
Fatty acid composition of red blood cells due to dietary habits
Time frame: 1 day ( first visit)
Fatty acid composition of red blood cells due to dietary habits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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?
An observational study of Healthy, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jul 2018. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fatty acid composition of red blood cells due to dietary habits (time frame: 1 day ( first visit)). 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 26 Jul 2018.