CLA Intake From Different Food SourcesNCT02335762
Dietary Conjugated Linoleic Acid (CLA) Intake Among Students in Italy
An observational study of CLA Intake From Different Food Sources, run by Catholic University of the Sacred Heart.
Trial summary
40 healthy subjects were recruited using advertisements posted at the Catholic University of Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a Gima scale) of each subject were measured and the body mass index (BMI) was calculated (kg/m2). Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- CLA Intake From Different Food Sources
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2012
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 40 healthy students
Who may be able to join
- self-reported healthy
- not suffering disorders of lipid metabolism and from eating disorders.
Who cannot join
- pregnant or breast-feeding,
- subjects consuming an energy-restricted diet
- vegan or vegetarians.
About this study
Official title: Dietary Intake of Conjugated Linoleic Acid in a Cohort of Healthy Students in Italy
40 healthy subjects were recruited using advertisements posted at the Catholic University of Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a Gima scale) of each subject were measured and the body mass index (BMI) was calculated (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all food and drink consumed daily for 3 days using a diary previously used in the Italian National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate as best their habits. They were educated to report also the place, time, number and quantity of serving portions consumed. If they were not able to weight exactly each portion, a photographic atlas developed for the Italian component of the European Prospective Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days the food diaries were checked and for each subject the energy intake was estimated.
- Conditions
- CLA Intake From Different Food Sources
What is being measured
The primary outcome is the main question the study is designed to answer.
CLA intake (food questionnaire crossed with data on CLA amount in foods)
food questionnaire crossed with data on CLA amount in foods
Measured: 3 days
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 startJan 2012
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLA Intake From Different Food SourcesStudies 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Rossi, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335762
- Sponsor's protocol ID
- 24475/14
- Status last verified
- Jan 2015
- First submitted
- 15 Dec 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake of Conjugated Linoleic Acid in a Cohort of Healthy Students in Italy
- ClinicalTrials.gov ID
- NCT02335762
- Acronym / sponsor ID
- 24475/14
- Conditions
- CLA Intake From Different Food Sources
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- 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.
40 healthy subjects were recruited using advertisements posted at the Catholic University of Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a Gima scale) of each subject were measured and the body mass index (BMI) was calculated (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all food and drink consumed daily for 3 days using a diary previously used in the Italian National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate as best their habits. They were educated to report also the place, time, number and quantity of serving portions consumed. If they were not able to weight exactly each portion, a photographic atlas developed for the Italian component of the European Prospective Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days the food diaries were checked and for each subject the energy intake was estimated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 healthy students
Key inclusion criteria (2 listed)
- self-reported healthy
- not suffering disorders of lipid metabolism and from eating disorders.
Key exclusion criteria (3 listed)
- pregnant or breast-feeding,
- subjects consuming an energy-restricted diet
- vegan or vegetarians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CLA intake (food questionnaire crossed with data on CLA amount in foods)
Time frame: 3 days
food questionnaire crossed with data on CLA amount in foods
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 14 Jan 2015.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of CLA Intake From Different Food Sources, run by Catholic University of the Sacred Heart.
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 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 14 Jan 2015. 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?
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?
CLA intake (food questionnaire crossed with data on CLA amount in foods) (time frame: 3 days). 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 14 Jan 2015.