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The objective of this study is to determine the influence of an increase of meat in complementary food on iron status and the effect of an exchange of vegetable oil in the same food on the status of omega-3 fatty acids in infants in the second six months of life.
Because of rapid growth in the first year of life, infants are at a high risk to develop iron deficiency (ID) or even iron deficiency anaemia (IDA). Iron metabolism in infancy seems to be immature and to be affected by developmental changes and is not yet fully understood. Therefore studies with both, detailed dietary intake and a full set of biomarkers to characterize iron status or the risk of IDA are welcome.
LC-PUFA, especially docosahexaenoic acid (DHA, n-3), are of important meaning in infants´ neural development because neural tissues have a unique pattern of FA. DHA is predominantly found in brain and retina. LC-PUFA can be either supplied preformed by diet or converted from their essential precursors the polyunsaturated fatty acids (PUFA) linoleic acid (LA, n-6) and α-linolenic acid (ALA, n-3) by the organism dependent on the ratio of n-6/n-3 FA in the diet.
In the case of iron as well as of PUFA and LC-PUFA very little is known about the nutritional supply and its effect on status in the second half of the first year of life. Therefore the objective of DINO is to examine the feasibility of increasing meat and of exchanging n-6 rich corn oil vs. n-3 rich rapeseed oil in common commercial menus and to examine the effects on iron status and on blood FA pattern respectively as primary outcome variables in a double-blinded randomized controlled intervention trial (RCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Babyfood with usual meat content and corn oil | Active Comparator | Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany. |
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| more meat and a vegetable oil rich in omega-3 fatty acids | Experimental | Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| more meat and a vegetable oil rich in omega-3 fatty acids | Other | The vegetable-potato-meat-meal was given 5 to 7 times a week for at least during the seventh to tenth month. The intervention meals had more meat (about 13 % of weight) and rapeseed oil (rich in omega-3 fatty acids). |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Omega-3 Fatty Acid Pattern in Plasma | fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids. Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th). | at the end of the tenth month of life |
| Parameters of Iron Status in Blood | at the end of the fourth, seventh, tenth month of life |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences | dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde Kersting, PD Dr. | Research Institute of Child Nutrition | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Child Nutrition | Dortmund | Nord-Rhein-Westfalen | 44225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19193660 | Result | Schwartz J, Dube K, Sichert-Hellert W, Kannenberg F, Kunz C, Kalhoff H, Kersting M. Modification of dietary polyunsaturated fatty acids via complementary food enhances n-3 long-chain polyunsaturated fatty acid synthesis in healthy infants: a double blinded randomised controlled trial. Arch Dis Child. 2009 Nov;94(11):876-82. doi: 10.1136/adc.2008.146027. Epub 2009 Feb 4. | |
| 19935821 |
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All of the 132 participants were randomly assigned to one of the two study groups.
Mothers were first contacted in the hospital 1-3 days after delivery. Of 832 contacted families 132 agreed to participate in the study up to the baby's age of 8 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants in the Control Group | Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany. |
| FG001 | Participants in the Intervention Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Babyfood with usual meat content and corn oil | Other | The active comparator (which is the control group) got babyfood with usual meat content (8%) and with corn oil, which is rich in omega 6 linoleic acid |
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| Schwartz J, Dube K, Alexy U, Kalhoff H, Kersting M. PUFA and LC-PUFA intake during the first year of life: can dietary practice achieve a guideline diet? Eur J Clin Nutr. 2010 Feb;64(2):124-30. doi: 10.1038/ejcn.2009.123. Epub 2009 Nov 25. |
| 19851802 | Result | Schwartz J, Drossard C, Dube K, Kannenberg F, Kunz C, Kalhoff H, Kersting M. Dietary intake and plasma concentrations of PUFA and LC-PUFA in breastfed and formula fed infants under real-life conditions. Eur J Nutr. 2010 Apr;49(3):189-95. doi: 10.1007/s00394-009-0067-1. Epub 2009 Oct 23. |
| 19618230 | Result | Dube K, Schwartz J, Mueller MJ, Kalhoff H, Kersting M. Complementary food with low (8%) or high (12%) meat content as source of dietary iron: a double-blinded randomized controlled trial. Eur J Nutr. 2010 Feb;49(1):11-8. doi: 10.1007/s00394-009-0043-9. Epub 2009 Jul 19. |
| 20627488 | Derived | Dube K, Schwartz J, Mueller MJ, Kalhoff H, Kersting M. Iron intake and iron status in breastfed infants during the first year of life. Clin Nutr. 2010 Dec;29(6):773-8. doi: 10.1016/j.clnu.2010.05.002. Epub 2010 Jun 2. |
Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants in the Control Group | Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany. |
| BG001 | Participants in the Intervention Group | Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sum of Omega-3 Fatty Acid Pattern in Plasma | fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids. Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th). | Posted | Median | Inter-Quartile Range | percent of total fatty acids | at the end of the tenth month of life |
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| Secondary | Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences | Not Posted | dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month | ||||||||||||||||||||||||||||||||||||
| Primary | Parameters of Iron Status in Blood | Not Posted | at the end of the fourth, seventh, tenth month of life |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants in the Control Group | Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany. | 0 | 66 | 0 | 66 | ||
| EG001 | Participants in the Intervention Group | Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil. | 0 | 66 | 0 | 66 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dortmund Intervention Trial for Optimization of Infant Nutrition | Research Institute of Child Nutrition | 0049 231 7922100 | kersting@fke-do.de |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Male |
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