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The effect of Frisian Flag GUM 456 (isomaltulose enriched and mineral and vitamin fortified) on cognitive performance parameters in young children.


- candidate number9425
- NTR NumberNTR2893
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mei-2011
- Secondary IDsNutr-AS-002-2011 FrieslandCampina Innovation International
- Public TitleThe effect of Frisian Flag GUM 456 (isomaltulose enriched and mineral and vitamin fortified) on cognitive performance parameters in young children.
- Scientific TitleThe effect of Frisian Flag GUM 456 (isomaltulose enriched and mineral and vitamin fortified) on cognitive performance parameters in young children.
- 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, Healthy children
- 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
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-mei-2011
- planned closingdate31-aug-2011
- Target number of participants120
- Interventions1. A: Regular Growing up Milk;
2. B : A + isomaltulose;
3. C : B with double isomaltulose;
4. D : B with mix of vitamins & minerals.
- 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 ANT test battery. Also antropometric measurements, height, weight, health questionaire, urine, heart rate.
- TimepointsT=0m;
T=90m;
T=180m.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Anne 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. Previous studies have shown a particular acute effect of isomaltulose and added minerals and vitamins on cognitive performance (in prep). This study aims at extending this finding and to optimize the formula. The study will be performed in indonesian children aged 5-6 years, recruited in Jakarta.
- Main changes (audit trail)
- RECORD11-mei-2011 - 24-mei-2011


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