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Clinical Trials/NCT00893529
NCT00893529CompletedNot Applicable

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

VU University of Amsterdam2 sites in 1 country641 target enrollmentStarted: May 1, 2009Last updated:
Conditions

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

Sponsor
VU University of Amsterdam
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Margreet R. Olthof

Dr ir

VU University of Amsterdam

Study Sites (2)

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