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van CCT (UK)

van CCT (UK)

Impact of different fibre mixtures on blood glucose response

- candidate number15678
- NTR NumberNTR4285
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-nov-2013
- Secondary IDsDGS.1.C/B/0 / Nutricia Research 
- Public TitleImpact of different fibre mixtures on blood glucose response
- Scientific TitleAn investigation into the acute glycaemic effects of breakfast cereals with different fibre conditions in young healthy adults
- hypothesisThe addition of a specific fibre mixture to a breakfast cereal will impact the blood glucose response.
- Healt Condition(s) or Problem(s) studiedAdults, Healthy elderly
- Inclusion criteriaAge 18-30 years
Male or female volunteers
BMI between 18-25
Diagnosis: self- assessed as healthy, confirmed by medical questionnaire during screening
Provide written informed consent
- Exclusion criteriaDiabetes Mellitus
History of heart disease and/or high blood pressure
Individuals who have any food intolerance or allergic reactions
Individuals currently taking regular medication or nutritional supplements (incl. vitamins) other than the contraceptive pill. Having participated in a drug or dietary intervention trial within the last 2 months prior to first test session
Non-native English speakers
Individuals with a history of neurological or psychiatric illness
Pregnant or lactating females
Frequent breakfast skippers
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate1-nov-2014
- Target number of participants35
- InterventionsDuration of intervention: approximately 3 weeks
Intervention: 5 different breakfast cereals will be consumed by subjects in a randomized, cross-over design. Duration of intervention: approximately 3 weeks
- Primary outcomeBlood glucose response
- Secondary outcome Safety and gastrointestinal tolerance
- Timepointsacute changes in blood glucose levels measured 8 times over a period of 3 hours.
- Trial web siteNA
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIES Bert Heijning, van de
- Sponsor/Initiator Nutricia Research Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research Foundation
- PublicationsNA
- Brief summaryIn this study, the effect of 5 different fibre mixtures on glucose response is assessed. In addition, safety and gastrointestinal tolerance will be monitored. Thirty-five healthy volunteers will consume these 5 study products in a randomized cross-over manner (>48 hours between each session).

Whole grain cereal had a lower glucose peak value compared to rice cereal. The glycaemic response overall (AUC) did not differ between the five different fibre mixtures. No safety and tolerance issues regarding the consumption of the five fibre mixtures were identified during the study.
- Main changes (audit trail)
- RECORD11-nov-2013 - 1-feb-2015

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