Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
VU University of Amsterdam ZonMw: The Netherlands Organisation for Health Research and Development Dutch Heart Foundation KNAW: Royal Netherlands Academy of Arts and Sciences |
---|---|
Information provided by: | VU University of Amsterdam |
ClinicalTrials.gov Identifier: | NCT00893529 |
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.
Condition | Intervention |
---|---|
Body Weight |
Dietary Supplement: lemonade with sugar Dietary Supplement: lemonade low in sugar |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized Trial of the Efficacy of Replacing Sugary Drinks by Low-Sugar Alternatives on Body Weight and Fat Mass in School Children |
Estimated Enrollment: | 600 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
dietary intervention 1: Experimental |
Dietary Supplement: lemonade with sugar
250 milliliters of lemonade with sugar daily for 18 months
|
dietary intervention 2: Experimental |
Dietary Supplement: lemonade low in sugar
250 milliliters of lemonade low in sugar daily for 18 months
|
Rationale: Liquid carbohydrates (including soft drinks as well as fruit juices) are thought to be less satiating then solid carbohydrates (e.g., bread or fruits). The hypothesis is that calories from sugary drinks might not be compensated for by eating less at subsequent meals and body weight would increase. In this way liquid carbohydrates might be one of the causes of becoming overweight and obesity. However, the evidence for a causal relation between sugary drinks and weight gain is inconclusive.
Objective: To test the effect of replacing sugar-containing beverages by beverages low in sugar on body weight and fat mass in children aged 5-10 years.
Study design: A double-blind, long term, randomized controlled trial.
Study population: Healthy school children in the age of 5-10 years old. We consider it unethical to encourage children to drink sugary drinks. Therefore children are only eligible if they already habitually consume 250 mL per day or more of sugary drinks.
Intervention: Six hundred healthy children (5-10 years) will be divided randomly into 2 groups. Group 1 (n=300) receives 250 mL per day of sugar-containing lemonade. Group 2 (n=300) receives 250 mL per day of lemonade low in sugar. The low-sugar drinks are sweetened with artificial sweeteners. The drinks will be consumed during the morning break during the weekdays at school and at home during weekends and holidays. The intervention period will be 18 months. Before the main trial starts feasibility and logistics will be tested in a pilot study. The design of the pilot study will be a 2-month randomized controlled trial in approximately 80 school children aged 5-10 years.
Main study parameters/endpoints: The primary outcomes of the study are the children's body weight (body mass index, corrected for age), waist circumference, skin folds and bioelectrical impedance. These outcomes will be measured four times during the study, at 0, 6, 12 and 18 months. As a secondary outcome we will also assess food intake of the children at lunch time, shortly after the morning break when the children have consumed the study drinks. This outcome will be measured at the start and at the end of the study.
Ages Eligible for Study: | 5 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janne de Ruyter, MSc | +31(0)611878804 | drink@vu.nl |
Netherlands | |
VU University Amsterdam | |
Amsterdam, Netherlands, 1081 HV |
Principal Investigator: | Martijn B Katan, Prof. Dr. | VU University of Amsterdam |
Principal Investigator: | Margreet R Olthof, Dr. | VU University of Amsterdam |
Responsible Party: | VU University Amsterdam ( Martijn Katan, Prof. dr. ) |
Study ID Numbers: | ZONMW120520010-NHS2008B096 |
Study First Received: | May 4, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00893529 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
overweight children intervention sugar-sweetened beverages |
Body Weight Signs and Symptoms Overweight |
Body Weight Signs and Symptoms |