Body WeightDRINKNCT00893529
A Study of the Effect of Replacing Sugary Drinks by Low-sugar Alternatives on Body Weight and Fat Mass in Children
A study testing lemonade with sugar and lemonade low in sugar in people with Body Weight, run by VU University of Amsterdam at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- lemonade with sugar and lemonade low in sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 641 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Body Weight
- Being tested
- lemonade with sugar, lemonade low in sugar
- Keywords
- overweight, children, intervention, sugar-sweetened beverages
- Medical subject headings
- Body Weight, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lemonade with sugarDietary supplement
250 milliliters of lemonade with sugar daily for 18 months
lemonade low in sugarDietary supplement
250 milliliters of lemonade low in sugar daily for 18 months
| Study group | Role | What they receive |
|---|---|---|
| dietary intervention 1 | Experimental | Not described Receives: Dietary Supplement: lemonade with sugar |
| dietary intervention 2 | Experimental | Not described Receives: Dietary Supplement: lemonade low in sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index Z-score
Measured: 0, 6, 12, and 18 months
Secondary outcomes (5)
Skinfolds
Measured: 0, 6, 12 and 18 months
Waist to height ratio
Measured: 0, 6, 12 and 18 months
Bioelectrical Impedance
% fat mass
Measured: 0, 6, 12 and 18 months
Dental health
Measured: 12 and 18 months
Sensory evaluation
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
Measured: 0, 6 ,12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Heart Foundation, KNAW: Royal Netherlands Academy of Arts and Sciences
- Responsible party
- Principal investigator, Margreet R. Olthof, VU University of Amsterdam
- Investigators
- Martijn B Katan, Prof. Dr., Principal investigator, VU University of AmsterdamMargreet R Olthof, Dr., Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893529
- Sponsor's protocol ID
- ZONMW120520010-NHS2008B096
- Acronym
- DRINK
- Status last verified
- Jun 2012
- First submitted
- 4 May 2009
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Katan MB, de Ruyter JC, Kuijper LD, Chow CC, Hall KD, Olthof MR. Impact of Masked Replacement of Sugar-Sweetened with Sugar-Free Beverages on Body Weight Increases with Initial BMI: Secondary Analysis of Data from an 18 Month Double-Blind Trial in Children. PLoS One. 2016 Jul 22;11(7):e0159771. doi: 10.1371/journal.pone.0159771. eCollection 2016.
PubMed 27447721de Ruyter JC, Katan MB, Kuijper LD, Liem DG, Olthof MR. The effect of sugar-free versus sugar-sweetened beverages on satiety, liking and wanting: an 18 month randomized double-blind trial in children. PLoS One. 2013 Oct 22;8(10):e78039. doi: 10.1371/journal.pone.0078039. eCollection 2013.
PubMed 24167595de Ruyter JC, Olthof MR, Seidell JC, Katan MB. A trial of sugar-free or sugar-sweetened beverages and body weight in children. N Engl J Med. 2012 Oct 11;367(15):1397-406. doi: 10.1056/NEJMoa1203034. Epub 2012 Sep 21.
PubMed 22998340
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00893529
- Acronym / sponsor ID
- DRINK / ZONMW120520010-NHS2008B096
- Conditions
- Body Weight
- Keywords
- overweight, children, intervention, sugar-sweetened beverages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Heart Foundation, KNAW: Royal Netherlands Academy of Arts and Sciences
- Study start
- May 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary intervention 1 | Experimental | Dietary Supplement: lemonade with sugar |
| dietary intervention 2 | Experimental | Dietary Supplement: lemonade low in sugar |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lemonade with sugar250 milliliters of lemonade with sugar daily for 18 months | Dietary supplement | dietary intervention 1 |
| lemonade low in sugar250 milliliters of lemonade low in sugar daily for 18 months | Dietary supplement | dietary intervention 2 |
Primary outcome
Body Mass Index Z-score
Time frame: 0, 6, 12, and 18 months
5 secondary outcomes
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
Dental health
Time frame: 12 and 18 months
Sensory evaluation
Time frame: 0, 6 ,12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Derived from this study: PubMed 27447721Katan MB, de Ruyter JC, Kuijper LD, Chow CC, Hall KD, Olthof MR. Impact of Masked Replacement of Sugar-Sweetened with Sugar-Free Beverages on Body Weight Increases with Initial BMI: Secondary Analysis of Data from an 18 Month Double-Blind Trial in Children. PLoS One. 2016 Jul 22;11(7):e0159771. doi: 10.1371/journal.pone.0159771. eCollection 2016.
- Derived from this study: PubMed 24167595de Ruyter JC, Katan MB, Kuijper LD, Liem DG, Olthof MR. The effect of sugar-free versus sugar-sweetened beverages on satiety, liking and wanting: an 18 month randomized double-blind trial in children. PLoS One. 2013 Oct 22;8(10):e78039. doi: 10.1371/journal.pone.0078039. eCollection 2013.
- Derived from this study: PubMed 22998340de Ruyter JC, Olthof MR, Seidell JC, Katan MB. A trial of sugar-free or sugar-sweetened beverages and body weight in children. N Engl J Med. 2012 Oct 11;367(15):1397-406. doi: 10.1056/NEJMoa1203034. Epub 2012 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn B Katan, Prof. Dr. principal investigator
VU University of Amsterdam
Margreet R Olthof, Dr. principal investigator
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lemonade with sugar and lemonade low in sugar in people with Body Weight, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index Z-score (time frame: 0, 6, 12, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00893529, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.