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An exploratory study to evaluate the effect of a new study product on early programming in healthy infants.


- candidate number9039
- NTR NumberNTR2721
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jan-2011
- Secondary IDsMET.3.C/D Danone Research
- Public TitleAn exploratory study to evaluate the effect of a new study product on early programming in healthy infants.
- Scientific TitleAn exploratory study to evaluate the effect of a new study product on early programming in healthy infants.
- ACRONYMEAGLE 2
- hypothesisThe investigational formula will be equivalent to the control formula with regard to the postprandial blood lipid parameters.
- Healt Condition(s) or Problem(s) studiedHealthy full-term infants
- Inclusion criteria1. Healthy and full-term infants (gestational age between 37 and 42 weeks);
2. Birth weight within the normal range for gestational age and sex (10th to 90 percentiles according to applicable growth charts);
3. Age 7 weeks at screening;
4. Body weight appropriate for the individual age and sex at screening (10th to 90 percentiles according to applicable growth charts);
5. Infants who are fully formula fed or have started the transition from breast to formula-feeding (indicated by the feeding of at least one bottle of infant formula in the past) and are planning to stop breastfeeding voluntarily by infant's age of 7 weeks;
6. Written informed consent of both parent(s)/legal guardian(s).
- Exclusion criteria1. Infants not on full formula feeding at the age of 7 weeks (to be answered latest at the age of 8 weeks (visit 2));
2. Infants with known congenital diseases or malfunctions e.g. gastrointestinal malformations, haemophilia;
3. Current or previous illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation);
4. Infants with abnormal growth (too slow (<_-1SD) or too fast (> +1SD) weight gain) within the 10th to 90th percentiles of applicable weight-for-age charts for either boys or girls;
5. Infants at high risk to develop an atopic disease (at least one parent or sibling with manifest atopic symptoms of hay fever, asthma or atopic dermatitis);
6. Infants needing a special diet other than standard cow's milk-based infant.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-feb-2011
- planned closingdate30-nov-2011
- Target number of participants28
- Interventions7 weeks randomised on either investigational or control product. The investigational product is a new formula containing CLM. The control product is a standard formula.

The intervention starts at the age of 8 weeks end ends at the age of 15 weeks. Until the age of 8 weeks, infants consume a run-in product, a currently market standard infant formula. They have to start with this run-in product, latest at the age of 7 weeks but may start earlier, depending on the time point of recruitment. After the age of 15 weeks, they get a wash-out product, which is again a currently market standard infant formula (same as run-in). This has to be consumed for 5 days.

CLM, in short: "Complex Lipid Matrix" (CLM), are large fat droplets stabilized by added phospholipids.

In total, the nutrient content of the new formula is (except for the content of phospholipids) the same as the nutrient content of the control formula, only the fat droplets are bigger (closer to droplets in breast milk).
- Primary outcomeDigestion and absorption, measured as blood lipid parameters.
- Secondary outcomeN/A
- Timepoints1. Visit 1/Screening (age < 7 weeks);
2. Visit 2 (age 8 weeks) phone call (age 9 weeks);
3. Visit 3 ( age 15 weeks);
4. Visit 4 (age 15 weeks);
5. Visit 5 (age -15 weeks+ 5 days), phone call (age 16 weeks).
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES Jan van der Mooren
- CONTACT for SCIENTIFIC QUERIES Jan van der Mooren
- Sponsor/Initiator Danone Research B.V., Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryThis study aims to investigate the impact of the new infant formula compared to a standard infant formula primarily on blood lipid parameters, and in addition on safety and tolerance. The study is designed with a run-in of 1-7 weeks and wash out period of 5 days on a currently marketed standard formula. On 2 examination days 2 blood samples will be withdrawn via heel prick from each infant, one day after run-in period (Visit 2) one day after wash-out period (Visit 5).
- Main changes (audit trail)14-mei-2017 - MT
Intervention:
The intervention starts at the age of 8 weeks end ends at the age of 15 weeks. Until the age of 8 weeks, infants consume a run-in product, a currently market standard infant formula. They have to start with this run-in product, latest at the age of 7 weeks but may start earlier, depending on the time point of recruitment. After the age of 15 weeks, they get a wash-out product, which is again a currently market standard infant formula (same as run-in). This has to be consumed for 5 days.

Replaced by

The investigational product is a new formula containing a “Complex Lipid Matrix, (CLM). The control product is a standard infant formula. The 7 weeks intervention starts at the age of 8 weeks and ends at the age of 15 weeks. Subjects are randomised on either investigational or control product. Until the age of 8 weeks, infants consume a run-in product, a currently market standard infant formula. After the age of 15 weeks, they get a wash-out product for 5 days, which is the same as run-in.

Brief summary of results :
This study was prematurely terminated.The sample size was insufficient to perform a statistical comparison. All infants included so far completed the study and no safety issues were reported.
- RECORD27-jan-2011 - 14-mei-2017


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