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A Study of the Effect of Replacing Sugary Drinks by Low-Sugar Alternatives on Body Weight and Fat Mass in Children (DRINK)
This study is not yet open for participant recruitment.
Verified by VU University of Amsterdam, May 2009
First Received: May 4, 2009   No Changes Posted
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
  Purpose

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

MedlinePlus related topics: Dietary Supplements Diets
U.S. FDA Resources
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

Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • Body weight [ Time Frame: 0, 6, 12, and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body length [ Time Frame: 0, 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Skinfolds [ Time Frame: 0, 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 0, 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Bioelectrical Impedance [ Time Frame: 0, 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Energy intake at lunch time [ Time Frame: 0 and 18 months ] [ Designated as safety issue: No ]

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

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. 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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893529

Contacts
Contact: Janne de Ruyter, MSc +31(0)611878804 drink@vu.nl

Locations
Netherlands
VU University Amsterdam
Amsterdam, Netherlands, 1081 HV
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
Investigators
Principal Investigator: Martijn B Katan, Prof. Dr. VU University of Amsterdam
Principal Investigator: Margreet R Olthof, Dr. VU University of Amsterdam
  More Information

No publications provided

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)

Keywords provided by VU University of Amsterdam:
overweight
children
intervention
sugar-sweetened beverages

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 07, 2009