Eating DisorderNCT01985178
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
A study testing Omega-3 Fatty Acid Supplement in people with Eating Disorder, run by McMaster University at 1 site in Canada.
Trial summary
Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Omega-3 Fatty Acid Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Aug 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of Eating Disorder, less than 18 years of age
Who cannot join
- unable to read and understand English
Trial locations and contacts
1 site in 1 country.
About this study
Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. These fatty acids are essential components of the brain and are important for normal functioning of the body. Since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. The investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.
- Conditions
- Eating Disorder
- Being tested
- Omega-3 Fatty Acid Supplement
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty Acid SupplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fatty Acid Supplement | Experimental | Not described Receives: Dietary Supplement: Omega-3 Fatty Acid Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout rate
Measured: 2 months
Secondary outcomes (2)
Rate of patients reporting side effects
Measured: 2 months
Change in weight
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Couturier, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985178
- Sponsor's protocol ID
- 12345
- Status last verified
- Apr 2015
- First submitted
- 19 Sep 2013
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders
- ClinicalTrials.gov ID
- NCT01985178
- Acronym / sponsor ID
- 12345
- Conditions
- Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Nov 2013 (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.
Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. These fatty acids are essential components of the brain and are important for normal functioning of the body. Since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. The investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fatty Acid Supplement | Experimental | Dietary Supplement: Omega-3 Fatty Acid Supplement |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosis of Eating Disorder, less than 18 years of age
Key exclusion criteria (1 listed)
- unable to read and understand English
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 |
|---|---|---|
| Omega-3 Fatty Acid Supplement | Dietary supplement | Omega-3 Fatty Acid Supplement |
Primary outcome
Dropout rate
Time frame: 2 months
2 secondary outcomes
Rate of patients reporting side effects
Time frame: 2 months
Change in weight
Time frame: 2 months
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 22 Dec 2020.
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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.
Jennifer Couturier, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acid Supplement in people with Eating Disorder, run by McMaster University at 1 site in Canada.
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 1 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 22 Dec 2020. 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 Canada. 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?
Dropout rate (time frame: 2 months). 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 22 Dec 2020.