Fatty Acid Status, Iron Status
Conditions
Keywords
infant, complementary food, iron, meat, LC-PUFA, omega-3,, rapeseed oil, diet
Brief summary
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.
Detailed description
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).
Interventions
OTHERmore meat and a vegetable oil rich in omega-3 fatty acids
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).
OTHERBabyfood with usual meat content and corn oil
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
Sponsors
Research Institute of Child Nutrition, Dortmund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* a term healthy newborn infant (birth weight \> 2500 g, gestational age \> 37 weeks); * inclusion during the first two months of life. * German speaking mother; * the intention of the mother to breast-feed the child and to feed study menus 5 to 7 times per week beginning in the fifth to seventh month of life.
Exclusion criteria
* preterm infants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Omega-3 Fatty Acid Pattern in Plasma | at the end of the tenth month of life | 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). |
| Parameters of Iron Status in Blood | at the end of the fourth, seventh, tenth month of life | — |
Secondary
| Measure | 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 |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
All of the 132 participants were randomly assigned to one of the two study groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| 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. | 66 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | infant refused study meal | 3 | 4 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Parent were afraid of blood colection | 2 | 5 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Participants in the Control Group | Participants in the Intervention Group | Total |
|---|---|---|---|
| Age, Customized <=2 months at beginning | 66 Participants | 66 Participants | 132 Participants |
| Region of Enrollment Germany | 66 participants | 66 participants | 132 participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 67 Participants |
| Sex: Female, Male Male | 31 Participants | 34 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Parameters of Iron Status in Blood
Time frame: at the end of the fourth, seventh, tenth month of life
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).
Time frame: at the end of the tenth month of life
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants in the Control Group | Sum of Omega-3 Fatty Acid Pattern in Plasma | 2.66 percent of total fatty acids |
| Participants in the Intervention Group | Sum of Omega-3 Fatty Acid Pattern in Plasma | 3.02 percent of total fatty acids |
Secondary
Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences
Time frame: 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