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The effect of isomaltulose enriched and mineral and vitamin fortified growing-up milk on cognitive performance in young children (5-6 years old).


- candidate number8038
- NTR NumberNTR2313
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mei-2010
- Secondary IDsNutr-AS-002-2010 FrieslandCampina Innovation International
- Public TitleThe effect of isomaltulose enriched and mineral and vitamin fortified growing-up milk on cognitive performance in young children (5-6 years old).
- Scientific TitleThe effect of isomaltulose enriched and mineral and vitamin fortified growing-up milk on cognitive performance in young children (5-6 years old).
- ACRONYM
- hypothesisIsomaltulose reduces the decline in working memory and attention span in older children.
This reduction in decline is also seen when lower amounts of isomaltulose are combined with a mix of minerals and vitamins.
- Healt Condition(s) or Problem(s) studiedMemory, Attention span
- Inclusion criteria1. Normal score on Wechsler Scales;
2. Hb within the normal range;
3. Average height;
4. Normal body weight;
5. Normal dietary pattern (food questionnaire);
6. Regular and easy milk consumption (2*200 ml per day).
- Exclusion criteriaSymptoms of or diagnosed for allergy, chronic infections, thyroid disorders, diabetes or lactose intolerance, and mental disturbances or retarded development.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2010
- planned closingdate1-okt-2010
- Target number of participants50
- Interventions1. A: Regular Growing up milk (GUM);
2. B: A + Isomaltulose;
3. C: A + Isomaltulose and lowered protein;
4. D: A + Isomaltulose (half the dose of B) + mix of vitamins and minerals.
Each test product will be consumed for 14 days.
- Primary outcomeScores on memory and attention span during the first 180 minutes following the consumption of the test product.
- Secondary outcomeOther markers of cognitive performance that come from the use of the UBC test battery.
- TimepointsCognitive performance tests will be done at baseline and 60, 120 and 180 minutes postdose. Cognitive performance tests will be done on the last day of the intervention period.

The cognitive performance is measured by the CDR System, a cognitive performance test battery, from United Biosource Corporation, Wayne, USA.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Schaafsma
- CONTACT for SCIENTIFIC QUERIES A. Schaafsma
- Sponsor/Initiator Fakultas Kedokteran Universitas Indonesia
- Funding
(Source(s) of Monetary or Material Support)
FrieslandCampina
- PublicationsN/A
- Brief summaryThere is much evidence to support positive effects of breakfast on cognitive performance of children. Sofar this is especially related to the glycemic index of the meals, the carbohydrates in particular. This study intends to show the particular acute effect of two doses of isomaltulose (5 and 2.5 g per serving), with a glycemic index of 32, as added to minerals and vitamins enriched growing up milk on cognitive performance (working memory and attention span in particular). The study will be performed in indonesian children aged 5-6 years recruited in Jakarta.
- Main changes (audit trail)
- RECORD4-mei-2010 - 23-mei-2010


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