Fatty Acid StatusPINGUNCT01487889
Polyunsaturated Fatty Acids in Child Nutrition
A study testing Fatty acid composition of complementary food in people with Fatty Acid Status, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
Trial summary
Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development. Read more about this study
- Who is it for?
- Ages Up to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Fatty Acid Status
- What is being tested?
- Fatty acid composition of complementary food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Sep 2013
- 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 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- a term healthy newborn infant ( birth weight > 2500 g, gestational age > 37 weeks
- German speaking mother
- the intention of the mother to breast-feed the children and to feed study menus at least 5 times per week beginning in the fifth to seventh month of life.
Who cannot join
- preterm children
- twins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study
Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development.
Subjects are randomly assigned to one of three groups:
Read more
- Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3 LC-PUFA metabolism)
- Fatty fish (preformed n-3 LC-PUFA, especially DHA)
- Corn oil (as control group, high in n-6 PUFA, common in complementary food).
The intervention starts with the beginning of complementary feeding as generally recommended between 4 to 6 months of age and ends at the age of 10 months. For this period of time subjects of all groups receive commercial vegetable-potato-meat-meals as part of complementary food which only differs in the fatty acid composition.
Read the detailed description
A well balanced supply of polyunsaturated fatty acids, in particular the omega-3 long chain docosahexaenoic acid (DHA), in early childhood is essential for children's cognitive and visual development. DHA can either be supplied preformed in the diet (e.g. via fatty fish) or synthesised by conversion of its essential precursor alpha-linolenic acid (e.g. via rapeseed oil). The study examines the effect of two different approaches to optimise infants´ fatty acid status.
The study sample consists of healthy newborns and their mothers (3 x 57 infants according to a priori power calculation) who are enrolled in delivery hospitals in the region of Dortmund, Germany. In total, the individual study program covers the first 10 months of infant's life. Biomarkers of fatty acid status from the mother are collected 8 weeks pp for the estimation of pre- and perinatal fatty acid supply. Additionally, information on maternal diet during pregnancy and after delivery is assessed. The intervention covers the period of complementary feeding (from 4 to 6 months of age until 10 months of age). In all groups the specific study food is given 5 to 7 times a week, whereas 2 of these are fish meals in the fatty fish group. At the age of 4 and 10 months blood samples are collected from the infants to examine the effect on blood fatty acid status. Parameters of visual and cognitive development are also assessed at the age of 4 and 10 months using VEP examinations and Bayley scales. Infants´ dietary intake is assessed from the end of the 2 months until 10 months of age using continuous weighed dietary records.
- Conditions
- Fatty Acid Status
- Being tested
- Fatty acid composition of complementary food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatty acid composition of complementary foodOther
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
| Study group | Role | What they receive |
|---|---|---|
| Rapeseed oil | Experimental | Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food Receives: Other: Fatty acid composition of complementary food |
| Fatty fish | Experimental | Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food. Receives: Other: Fatty acid composition of complementary food |
| Corn oil | Active comparator | Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food Receives: Other: Fatty acid composition of complementary food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants´ fatty acid status
Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, and cheek cells in order to assess the fatty acid composition.
Measured: 10 months after delivery
Secondary outcomes (13)
Infants´ visual development
Infants´ visual development is assessed using the visual evoked potentials method.
Measured: 10 months after delivery
Infants´ cognitive development
Infants´ cognitive development is assessed using the Bayley II scale.
Measured: 10 months after delivery
Infants´ haemogram
Measured: 10 months after delivery
Infants´antioxidant status
Measured: 10 months after delivery
Infants´ body weight
Measured: 10 months after delivery
Infants´ dietary intake
Measured: from 2 until 10 months after delivery
Maternal dietary intake
Measured: pregnancy and first 2 months post partum
Infant's preference for fish
Measured: 10 month after delivery
Infant's preference for new flavour
Measured: 10 month after delivery
Parental attitudes about fish and feeding strategies
Measured: 10 months after delivery
Mother´s fatty acid status
Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, cheek cells, and breast milk in order to assess the fatty acid composition.
Measured: 2 months after delivery
Infants´ body length
Measured: 10 months after delivery
Infant´s head circumference
Measured: 10 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty Acid StatusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Child Nutrition, Dortmund
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. von Hauner Children's Hospital, Germany, University of Potsdam, Pediatric Clinic Dortmund, Germany
- Responsible party
- Sponsor
- Investigators
- Mathilde Kersting, Professor, Study director, Research Institute of Child Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487889
- Sponsor's protocol ID
- PINGU0911DO
- Acronym
- PINGU
- Status last verified
- Nov 2014
- First submitted
- 15 Sep 2011
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Libuda L, Mesch CM, Stimming M, Demmelmair H, Koletzko B, Warschburger P, Blanke K, Reischl E, Kalhoff H, Kersting M. Fatty acid supply with complementary foods and LC-PUFA status in healthy infants: results of a randomised controlled trial. Eur J Nutr. 2016 Jun;55(4):1633-44. doi: 10.1007/s00394-015-0982-2. Epub 2015 Jul 14.
PubMed 26169870
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study
- ClinicalTrials.gov ID
- NCT01487889
- Acronym / sponsor ID
- PINGU / PINGU0911DO
- Conditions
- Fatty Acid Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Collaborators
- Dr. von Hauner Children's Hospital, Germany, University of Potsdam, Pediatric Clinic Dortmund, Germany
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Dec 2011 (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.
Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development.
Subjects are randomly assigned to one of three groups:
- Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3 LC-PUFA metabolism)
- Fatty fish (preformed n-3 LC-PUFA, especially DHA)
- Corn oil (as control group, high in n-6 PUFA, common in complementary food).
The intervention starts with the beginning of complementary feeding as generally recommended between 4 to 6 months of age and ends at the age of 10 months. For this period of time subjects of all groups receive commercial vegetable-potato-meat-meals as part of complementary food which only differs in the fatty acid composition.
Detailed description
A well balanced supply of polyunsaturated fatty acids, in particular the omega-3 long chain docosahexaenoic acid (DHA), in early childhood is essential for children's cognitive and visual development. DHA can either be supplied preformed in the diet (e.g. via fatty fish) or synthesised by conversion of its essential precursor alpha-linolenic acid (e.g. via rapeseed oil). The study examines the effect of two different approaches to optimise infants´ fatty acid status.
The study sample consists of healthy newborns and their mothers (3 x 57 infants according to a priori power calculation) who are enrolled in delivery hospitals in the region of Dortmund, Germany. In total, the individual study program covers the first 10 months of infant's life. Biomarkers of fatty acid status from the mother are collected 8 weeks pp for the estimation of pre- and perinatal fatty acid supply. Additionally, information on maternal diet during pregnancy and after delivery is assessed. The intervention covers the period of complementary feeding (from 4 to 6 months of age until 10 months of age). In all groups the specific study food is given 5 to 7 times a week, whereas 2 of these are fish meals in the fatty fish group. At the age of 4 and 10 months blood samples are collected from the infants to examine the effect on blood fatty acid status. Parameters of visual and cognitive development are also assessed at the age of 4 and 10 months using VEP examinations and Bayley scales. Infants´ dietary intake is assessed from the end of the 2 months until 10 months of age using continuous weighed dietary records.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapeseed oil | Experimental | Other: Fatty acid composition of complementary foodStudy group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food |
| Fatty fish | Experimental | Other: Fatty acid composition of complementary foodStudy group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food. |
| Corn oil | Active comparator | Other: Fatty acid composition of complementary foodStudy group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- a term healthy newborn infant ( birth weight > 2500 g, gestational age > 37 weeks
- German speaking mother
- the intention of the mother to breast-feed the children and to feed study menus at least 5 times per week beginning in the fifth to seventh month of life.
Key exclusion criteria (2 listed)
- preterm children
- twins
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 |
|---|---|---|
| Fatty acid composition of complementary foodGroups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition | Other | Corn oil, Fatty fish, Rapeseed oil |
Primary outcome
Infants´ fatty acid status
Time frame: 10 months after delivery
Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, and cheek cells in order to assess the fatty acid composition.
13 secondary outcomes
Infants´ visual development
Time frame: 10 months after delivery
Infants´ cognitive development
Time frame: 10 months after delivery
Infants´ haemogram
Time frame: 10 months after delivery
Infants´antioxidant status
Time frame: 10 months after delivery
Infants´ body weight
Time frame: 10 months after delivery
Infants´ dietary intake
Time frame: from 2 until 10 months after delivery
Maternal dietary intake
Time frame: pregnancy and first 2 months post partum
Infant's preference for fish
Time frame: 10 month after delivery
Infant's preference for new flavour
Time frame: 10 month after delivery
Parental attitudes about fish and feeding strategies
Time frame: 10 months after delivery
Mother´s fatty acid status
Time frame: 2 months after delivery
Infants´ body length
Time frame: 10 months after delivery
Infant´s head circumference
Time frame: 10 months after delivery
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 6 Nov 2014.
- Derived from this study: PubMed 26169870Libuda L, Mesch CM, Stimming M, Demmelmair H, Koletzko B, Warschburger P, Blanke K, Reischl E, Kalhoff H, Kersting M. Fatty acid supply with complementary foods and LC-PUFA status in healthy infants: results of a randomised controlled trial. Eur J Nutr. 2016 Jun;55(4):1633-44. doi: 10.1007/s00394-015-0982-2. Epub 2015 Jul 14.
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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.
Mathilde Kersting, Professor study director
Research Institute of Child Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatty acid composition of complementary food in people with Fatty Acid Status, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
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 3 inclusion and 2 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 6 Nov 2014. 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 Germany. 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?
Infants´ fatty acid status (time frame: 10 months after delivery). 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 NCT01487889, which also lists 1 linked publication.
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 6 Nov 2014.