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van CCT (UK)

van CCT (UK)


- candidate number16783
- NTR NumberNTR4463
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2014
- Secondary IDs133056 METC azM
- Public TitleSTRONG
- Scientific TitleA study to evaluate the postprandial, short term effects of two baby nutrition products in healthy adult, male volunteers
- hypothesisThe postprandial profile of plasma TG after ingestion of the active product is different to the control.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers
- Inclusion criteria- Healthy, adult, male, Caucasian, Dutch-speaking subjects - Non-smokers - Lactose- and milk-tolerant - Age 18-25 yr - Body Mass Index (BMI) of 20-25 kg/m2 - Girth width <100 cm - Stable body weight (weight gain or loss < 2 kg in the past three months) - Written informed consent - Willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study, and 4 weeks after the study (i.e. after the follow-up phone call)
- Exclusion criteria-Top sports men or athletes with a daily strenuous training program (>2 hr/day) -Known diseases or malfunctions e.g. fat malabsorption, gastrointestinal malformations, haemophilia, hepatitis B, human immunodeficiency virus (HIV), high blood-pressure, hyperlipidaemia or diabetes - Current illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation, severe flu): to be determined on judgement of the investigator. - Medication use (except for paracetamol) or a medically prescribed diet during the study - Any current participation, or participation within 8 weeks before study start, in any other study involving investigational or marketed products - Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements and instructions - More than 21 alcoholic consumptions per week
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-mrt-2014
- planned closingdate30-apr-2014
- Target number of participants30
- InterventionsDuration of intervention: 9-12 days, consisting of 2 test days within 2 weeks A follow up call will take place 2 weeks after the last test day.
- Primary outcomeThe primary outcome parameter in this study comprises the postprandial time course of plasma TG levels after ingestion of the active product vs. the control. Apart from plasma TG levels per se, either absolute (mM) or delta values, also the derivative AUC or iAUC are considered as primary outcome parameter.
- Secondary outcomeSeveral plasma/serum parameters in response to ingestion of the active (and control) products are assessed.
- TimepointsTime points of the outcome; V-1 (pre-test period), V0 (screening, randomization, test day) Wash out period of 5 days V-1 (pre-test period), V0 (test day) Follow up 2 weeks after final visit.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT for SCIENTIFIC QUERIES Bert Heijning, van de
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research Foundation
- Publications
- Brief summaryIn this study standard infant formula containing a new fat blend is compared with standard infant formula without this containing the standard fat blend. The main parameter being studied is the postprandial plasma triglyceride profile. The study comprises two similar test days separated by > 5 days (wash out). The 30 healthy volunteers enrolled are randomly allocated to consume these 2 study products in a randomised cross-over, double-blind, controlled manner ( > 5 days between each session).
- Main changes (audit trail)
- RECORD10-mrt-2014 - 8-sep-2014

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