- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335762
Dietary Conjugated Linoleic Acid (CLA) Intake Among Students in Italy
January 13, 2015 updated by: Filippo Rossi, Catholic University of the Sacred Heart
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
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
19 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
40 healthy students
Description
Inclusion Criteria:
- self-reported healthy
- not suffering disorders of lipid metabolism and from eating disorders.
Exclusion Criteria:
- pregnant or breast-feeding,
- subjects consuming an energy-restricted diet
- vegan or vegetarians.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2012
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 15, 2014
First Submitted That Met QC Criteria
January 9, 2015
First Posted (Estimate)
January 12, 2015
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 24475/14
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.