ObesityEFiONNCT00631046
Essential Fatty Acids During Complementary Feeding
A study testing Fish Oil and Sunflower Oil in people with Obesity and Growth, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers. Read more about this study
- Who is it for?
- Ages 8 to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Growth, Metabolic Syndrome
- What is being tested?
- Fish Oil and Sunflower Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to May 2009
- 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 8 to 19 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton infants, 9 mo +/- 2 wk, born >= 37 wk of gestation
- Birth weight >=2500g, a 5-min Apgar score >= 7, birth weight >= 5th percentile for gestational age
Who cannot join
- Chronic diseases expected to influence growth and dietary intake
- Use of medicine expected to influence growth and dietary intake
- Fish oil supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Increasing Intake of Essential Fatty Acids During Complementary Feeding on Infant Growth and Body Composition, Intestinal Health, Immune Function and Risk Markers for Later Metabolic Complications.
The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.
- Conditions
- Obesity, Growth, Metabolic Syndrome, Cardiovascular Disease
- Being tested
- Fish Oil, Sunflower Oil
- Keywords
- n-3 LCPUFA, Fish oil, essential fatty acids, infant growth, obesity, Intestinal microbiota
- Medical subject headings
- Obesity, Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Daily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
Sunflower OilDietary supplement
Daily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | containing n-3 LCPUFA Receives: Dietary Supplement: Fish Oil |
| Sunflower oil | Placebo comparator | containing n-6 PUFA Receives: Dietary Supplement: Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Body composition
Intestinal microbiota
Blood pressure
Plasma lipid profile
Insulin - glucose
Erythrocyte fatty acid composition
Ex vivo cytokine production
IGF-1 and IGFBP-3
Adipokines
Plasma CRP
Plasma IgE
Secondary outcomes (6)
Glucagon
Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Iron status (hemoglobin, ferritin)
faecal calprotectin
FADS1 and FADS2 genotypes
Allergy status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Axellus
- Investigators
- Kim F Michaelsen, Dr Med Sci, Principal investigator, Dept. of Human Nutrition, LIFE, Univ. of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631046
- Sponsor's protocol ID
- H-A-2007-0088
- Other IDs
- D203
- Acronym
- EFiON
- Status last verified
- Jul 2009
- First submitted
- 28 Feb 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
Publications
Lind MV, Martino D, Harslof LB, Kyjovska ZO, Kristensen M, Lauritzen L. Genome-wide identification of mononuclear cell DNA methylation sites potentially affected by fish oil supplementation in young infants: A pilot study. Prostaglandins Leukot Essent Fatty Acids. 2015 Oct;101:1-7. doi: 10.1016/j.plefa.2015.07.003. Epub 2015 Jul 23.
PubMed 26254087Harslof LB, Larsen LH, Ritz C, Hellgren LI, Michaelsen KF, Vogel U, Lauritzen L. FADS genotype and diet are important determinants of DHA status: a cross-sectional study in Danish infants. Am J Clin Nutr. 2013 Jun;97(6):1403-10. doi: 10.3945/ajcn.113.058685. Epub 2013 May 1.
PubMed 23636240Andersen AD, Molbak L, Michaelsen KF, Lauritzen L. Molecular fingerprints of the human fecal microbiota from 9 to 18 months old and the effect of fish oil supplementation. J Pediatr Gastroenterol Nutr. 2011 Sep;53(3):303-9. doi: 10.1097/MPG.0b013e31821d298f.
PubMed 21865979
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Increasing Intake of Essential Fatty Acids During Complementary Feeding on Infant Growth and Body Composition, Intestinal Health, Immune Function and Risk Markers for Later Metabolic Complications.
- ClinicalTrials.gov ID
- NCT00631046
- Acronym / sponsor ID
- EFiON / H-A-2007-0088
- Conditions
- Obesity, Growth, Metabolic Syndrome, Cardiovascular Disease
- Keywords
- n-3 LCPUFA, Fish oil, essential fatty acids, infant growth, obesity, Intestinal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Axellus
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Mar 2008 (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 objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish Oilcontaining n-3 LCPUFA |
| Sunflower oil | Placebo comparator | Dietary Supplement: Sunflower Oilcontaining n-6 PUFA |
Who may qualify
- Ages
- 8 to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Singleton infants, 9 mo +/- 2 wk, born >= 37 wk of gestation
- Birth weight >=2500g, a 5-min Apgar score >= 7, birth weight >= 5th percentile for gestational age
Key exclusion criteria (3 listed)
- Chronic diseases expected to influence growth and dietary intake
- Use of medicine expected to influence growth and dietary intake
- Fish oil supplementation
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 |
|---|---|---|
| Fish OilDaily dosage of 5 ml of fish oils from 9 months +/- 2weeks to 18 months +/- 4 weeks of age | Dietary supplement | Fish Oil |
| Sunflower OilDaily dosage of 5 ml of sunflower oil from 9 months +/- 2weeks to 18 months +/- 4 weeks of age | Dietary supplement | Sunflower oil |
Primary outcome
Growth
Body composition
Intestinal microbiota
Blood pressure
Plasma lipid profile
Insulin - glucose
Erythrocyte fatty acid composition
Ex vivo cytokine production
IGF-1 and IGFBP-3
Adipokines
Plasma CRP
Plasma IgE
6 secondary outcomes
Glucagon
Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
Iron status (hemoglobin, ferritin)
faecal calprotectin
FADS1 and FADS2 genotypes
Allergy status
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 15 Jul 2009.
- Derived from this study: PubMed 26254087Lind MV, Martino D, Harslof LB, Kyjovska ZO, Kristensen M, Lauritzen L. Genome-wide identification of mononuclear cell DNA methylation sites potentially affected by fish oil supplementation in young infants: A pilot study. Prostaglandins Leukot Essent Fatty Acids. 2015 Oct;101:1-7. doi: 10.1016/j.plefa.2015.07.003. Epub 2015 Jul 23.
- Derived from this study: PubMed 23636240Harslof LB, Larsen LH, Ritz C, Hellgren LI, Michaelsen KF, Vogel U, Lauritzen L. FADS genotype and diet are important determinants of DHA status: a cross-sectional study in Danish infants. Am J Clin Nutr. 2013 Jun;97(6):1403-10. doi: 10.3945/ajcn.113.058685. Epub 2013 May 1.
- Derived from this study: PubMed 21865979Andersen AD, Molbak L, Michaelsen KF, Lauritzen L. Molecular fingerprints of the human fecal microbiota from 9 to 18 months old and the effect of fish oil supplementation. J Pediatr Gastroenterol Nutr. 2011 Sep;53(3):303-9. doi: 10.1097/MPG.0b013e31821d298f.
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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.
Kim F Michaelsen, Dr Med Sci principal investigator
Dept. of Human Nutrition, LIFE, Univ. of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil and Sunflower Oil in people with Obesity and Growth, run by University of Copenhagen at 1 site in Denmark.
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 15 Jul 2009. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Growth. The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00631046, which also lists 3 linked publications.
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 15 Jul 2009.