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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 641
- Locations
- 2
- Primary Endpoint
- Body Mass Index Z-score
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy school boys and girls
- •Age 5 years and older, children still have to be in elementary school at the end of the study
- •Children who already habitually consume 250 mL per day or more of sugary drinks
Exclusion Criteria
- •Using medication or under medical treatment for obesity
- •Any acute or chronic disease such as diabetes, growth disorders, celiac disease, or serious gastroenterological diseases
- •Medical history or surgical events known to interfere with the study
- •Participation in another intervention trial up to 3 months before and during the study, if the intervention interferes with the current study
- •Physical disabilities that hamper the measurements
- •Intention to change location of residence and primary school during the study period
Outcomes
Primary Outcomes
Body Mass Index Z-score
Time Frame: 0, 6, 12, and 18 months
Secondary Outcomes
- Skinfolds(0, 6, 12 and 18 months)
- Waist to height ratio(0, 6, 12 and 18 months)
- Bioelectrical Impedance(0, 6, 12 and 18 months)
- Dental health(12 and 18 months)
- Sensory evaluation(0, 6 ,12 and 18 months)
Investigators
Margreet R. Olthof
Dr ir
VU University of Amsterdam