Randomised controlled trialindependent cross-checkabstract checked★ key study I-SOD-118 in-depth review

Sugar drinks made children gain more weight

A trial of sugar-free or sugar-sweetened beverages and body weight in children.

Overview

de Ruyter JC et al.. N Engl J Med 2012 · PMID 22998340 · DOI 10.1056/NEJMoa1203034

In an 18-month blinded trial, Dutch children given one sugary drink a day gained about 1 kg more than children given an identical-tasting sugar-free drink.

Does the study support the specific claim? Yes · Methodological quality: high

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Test whether replacing sugary drinks with sugar-free drinks reduces weight gain in children.

How was the study done?

Children received one can a day of either drink for 18 months without knowing which.

How many people, animals or samples were studied?

641 Dutch school children.

What was actually found?

Less weight and fat gain with sugar-free drinks.

How large was the observed effect?

Weight difference about -1.0 kg; BMI z -0.13.

What do the results mean in everyday life?

Liquid sugar adds weight because children do not eat less to compensate.

What are the study's limitations?

Many children stopped drinking; sensitivity analysis borderline.

What does it say about Elawady's specific claim?

Supports the claim.

Do the results apply to Germany and Europe?

Directly European.

What can explicitly not be concluded from this study?

Cannot speak to adults or long-term disease.

Scientific in-depth review

1. Full reference

Authors
de Ruyter JC et al.
Journal
N Engl J Med
Year
2012
Identifier
PMID 22998340 DOI 10.1056/NEJMoa1203034
Verification
verified – PubMed efetch 2026-10-26 + Crossref 2026-10-26
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

Netherlands Organization for Health Research and Development and others (PubMed abstract)

2. Research question

Does masked replacement of sugar-containing beverages with non-caloric beverages reduce weight gain in children?

3. Study design and population

Study design
Randomised controlled trial – Double-blind randomised controlled trial, 18 months (DRINK; NCT00893529)
Population

Primarily normal-weight children aged 4 years 10 months to 11 years 11 months

Country

Netherlands

Period

18 months

Sample size

641 (477 completed)

Inclusion and exclusion criteria

School children; details in full text

4. Methods and endpoints

Exposure / intervention

250 mL/day sugar-containing beverage (104 kcal)

Comparator

250 mL/day artificially sweetened, sugar-free beverage

Endpoints

BMI z score; weight; skinfolds; waist-to-height ratio; fat mass

Statistical methods

Intention-to-treat with imputation

5. Actual results

Results

BMI z score +0.02 (sugar-free) vs +0.15 (sugar); difference CI -0.21 to -0.05. Weight +6.35 vs +7.37 kg (difference CI -1.54 to -0.48). Skinfolds, waist-to-height ratio and fat mass increased less in the sugar-free group. 26% stopped drinking the beverages; among completers plus measured dropouts, BMI z +0.06 vs +0.12 (P=0.06).

Absolute risks

not applicable

Authors' conclusion

Masked replacement of sugar-containing beverages with non-caloric beverages reduced weight gain and fat accumulation in normal-weight children.

6. Strengths

  • Double-blind (masked drinks)
  • 18 months
  • Objective measures

7. Weaknesses

  • 26% discontinued
  • Sensitivity analysis borderline (P=0.06)

8. Risk of bias

Orienting tool
RoB 2
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
some concerns
Rationale

Missing data handled by imputation.

9. Assessment of the statistical interpretation

Recalculated differences (-0.13 BMI z; -1.02 kg) match reported CIs (stats/C-SOD-02_deruyter.py). Blinding makes incomplete compensation for liquid sugar the most likely explanation.

10. Relevance to the specific claim

Strongest randomised evidence for C-SOD-02: sugary drinks cause extra weight gain in children, and because drinks were masked, children did not fully compensate for the liquid sugar calories.

11. Independent contrary findings

Ebbeling 2012 (I-SOD-119) found no difference at 2 years in adolescents.

12. Transferability to Germany and Europe

European trial; directly applicable.

13. Overall methodological judgement

High-quality causal evidence that sugar-sweetened drinks increase weight gain in children.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biassome concerns
Precision of resultsmoderate
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Long-term persistence.

15. Linked fact checks