|- candidate number||5696|
|- NTR Number||NTR1796|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mei-2009|
|- Secondary IDs||120520010 / 2008B096 ZONMW / NHS|
|- Public Title||A Study of the Effect of Replacing Sugary Drinks by Low-Sugar Alternatives on Body Weight and Fat Mass in Children (DRINK).|
|- Scientific Title||A double blind, randomized trial of the effects of liquid carbohydrates on body weight and fat mass in school children.|
|- ACRONYM||DRINK study|
|- hypothesis||The hypothesis is that intake of liquid carbohydrates is not compensated sufficiently by reducing caloric consumption from other foods. This leads to incomplete compensation for the energy ingested and eventually results in weight gain.|
|- Healt Condition(s) or Problem(s) studied||Overweight, Obesity|
|- Inclusion criteria||1. Healthy school going boys and girls;|
2. Age 5 years and older, children still have to be in elementary school at the end of the study;
3. Children who already habitually consume 250 mL per day or more of sugary drinks.
|- Exclusion criteria||1. Using medication or under medical treatment for obesity;|
2. Any acute or chronic disease such as diabetes, growth disorders, celiac disease, or serious gastroenterological diseases;
3. Medical history or surgical events known to interfere with the study;
4. Participation in another intervention trial up to 3 months before and during the study, if the intervention interferes with the current study;
5. Physical disabilities that hamper the measurements;
6. Intention to change location of residence and primary school during the study period.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||31-dec-2011|
|- Target number of participants||600|
|- Interventions||1. Intervention 1: 250 mL per day of sugar-containing lemonade;|
2. Intervention 2: 250 mL per day of lemonade low in sugar. The low-sugar drinks are sweetened with artificial sweeteners.
The intervention will take 18 months.
|- Primary outcome||BMI z-score.
|- Secondary outcome||1. Waist circumference;|
2. Bioelectrical impedance (% fat mass);
3. Sum of four skinfolds (mm);
4. Dental health;
5. Sensory evaluation.
|- Timepoints||0, 6, 12 and 18 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||dr. ir. Margreet R. Olthof|
|- CONTACT for SCIENTIFIC QUERIES||dr. ir. Margreet R. Olthof|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Dutch Heart Foundation (Nederlandse Hartstichting), Royal Netherlands Academy of Arts and Sciences |
|- Brief summary||Obesity results from an imbalance between energy intake and energy expenditure. There is much speculation about foods that are particularly fattening, and sugary drinks are seen as major culprits. It is hypothesized that a high intake of calories from sugary drinks would not be compensated for by reduced food intake at subsequent meals. As a result body weight would increase. In this double-blind, long term, randomized controlled trial the effect of replacing sugar-containing beverages by low-sugar alternatives on body weight and fat mass in children will be investigated.|
|- Main changes (audit trail)|
|- RECORD||4-mei-2009 - 21-mrt-2012|