A Study of the Effect of Replacing Sugary Drinks by Low-sugar Alternatives on Body Weight and Fat Mass in Children (DRINK)
|ClinicalTrials.gov Identifier: NCT00893529|
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : June 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Body Weight||Dietary Supplement: lemonade with sugar Dietary Supplement: lemonade low in sugar||Not Applicable|
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 outcome of the study is children's body weight (body mass index, corrected for age). Secondary endpoints are 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 perform a sensory evaluation at 0, 6, 12 and 18 months and a questionnaire about dental health at 12 and 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||641 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
|Experimental: dietary intervention 1||
Dietary Supplement: lemonade with sugar
250 milliliters of lemonade with sugar daily for 18 months
|Experimental: dietary intervention 2||
Dietary Supplement: lemonade low in sugar
250 milliliters of lemonade low in sugar daily for 18 months
- Body Mass Index Z-score [ Time Frame: 0, 6, 12, and 18 months ]
- Skinfolds [ Time Frame: 0, 6, 12 and 18 months ]
- Waist to height ratio [ Time Frame: 0, 6, 12 and 18 months ]
- Bioelectrical Impedance [ Time Frame: 0, 6, 12 and 18 months ]% fat mass
- Dental health [ Time Frame: 12 and 18 months ]
- Sensory evaluation [ Time Frame: 0, 6 ,12 and 18 months ]
We perform a sensory evaluation, to relate the effects at the end of the trial to properties of our drinks, asking:
- How much do you want to drink the study drink?
- How satiated do you feel?
- What do you eat together with the study drink?
- How much do you like the study drink?
The questionnaire includes pictures, and was tested at baseline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893529
|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|