A Study of the Effect of Replacing Sugary Drinks by Low-sugar Alternatives on Body Weight and Fat Mass in Children (DRINK)

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Heart Foundation
KNAW: Royal Netherlands Academy of Arts and Sciences
Information provided by (Responsible Party):
Margreet R. Olthof, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT00893529
First received: May 4, 2009
Last updated: June 13, 2012
Last verified: June 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Mass Index Z-score [ Time Frame: 0, 6, 12, and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skinfolds [ Time Frame: 0, 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • Waist to height ratio [ 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 ]
    % fat mass

  • Dental health [ Time Frame: 12 and 18 months ] [ Designated as safety issue: No ]
  • Sensory evaluation [ Time Frame: 0, 6 ,12 and 18 months ] [ Designated as safety issue: No ]

    We perform a sensory evaluation, to relate the effects at the end of the trial to properties of our drinks, asking:

    1. How much do you want to drink the study drink?
    2. How satiated do you feel?
    3. What do you eat together with the study drink?
    4. How much do you like the study drink?

    The questionnaire includes pictures, and was tested at baseline



Enrollment: 641
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 by VU University of Amsterdam

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margreet R. Olthof, Dr ir, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT00893529     History of Changes
Other Study ID Numbers: ZONMW120520010-NHS2008B096
Study First Received: May 4, 2009
Last Updated: June 13, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014