Randomised controlled trialindependent cross-checkabstract only checked★ key study I-FAST-03 in-depth review

Time-restricted eating plus calorie restriction

Calorie Restriction with or without Time-Restricted Eating in Weight Loss.

Overview

Liu D et al.. N Engl J Med 2022 · PMID 35443107 · DOI 10.1056/NEJMoa2114833

Adding an 8-hour eating window to calorie restriction did not significantly improve weight loss.

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

Original publication

Plain-language summary

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

Time-restricted eating plus calorie restriction vs calorie restriction alone

How was the study done?

RCT, 12 months

How many people, animals or samples were studied?

139; Adults with obesity

What was actually found?

No significant added benefit.

How large was the observed effect?

-1.8 kg (n.s.)

What do the results mean in everyday life?

Calorie reduction is what matters.

What are the study's limitations?

Single country

What does it say about Elawady's specific claim?

Limits C-FAST-02, C-FAST-05.

Do the results apply to Germany and Europe?

Chinese population; physiology transferable.

What can explicitly not be concluded from this study?

Effects without calorie restriction.

Scientific in-depth review

1. Full reference

Authors
Liu D et al.
Journal
N Engl J Med
Year
2022
Identifier
PMID 35443107 DOI 10.1056/NEJMoa2114833
Verification
verified – PubMed efetch 2026-10-25 (this agent)
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Time-restricted eating plus calorie restriction vs calorie restriction alone

3. Study design and population

Study design
Randomised controlled trial – RCT, 12 months
Population

Adults with obesity

Country

China

Period

12 months

Sample size

139

Inclusion and exclusion criteria

As described in the abstract; details not available in abstract.

4. Methods and endpoints

Exposure / intervention

8:00-16:00 eating window + calorie restriction

Comparator

Calorie restriction alone

Endpoints

Weight change; fat, metabolic markers

Statistical methods

Intention to treat

5. Actual results

Results

Weight -8.0 kg (-9.6 to -6.4) vs -6.3 kg (-7.8 to -4.7); difference -1.8 kg (-4.0 to 0.4; P=0.11); secondary outcomes consistent; no difference in adverse events.

Absolute risks

not reported

Authors' conclusion

TRE was not more beneficial than daily calorie restriction for weight, fat or metabolic risk factors.

6. Strengths

  • 12-month RCT
  • 85% completion

7. Weaknesses

  • Single country

8. Risk of bias

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

Adequate design.

9. Assessment of the statistical interpretation

Non-significant difference.

10. Relevance to the specific claim

Limits C-FAST-02, C-FAST-05.

11. Independent contrary findings

12. Transferability to Germany and Europe

Chinese population; physiology transferable.

13. Overall methodological judgement

High-quality evidence of no added benefit.

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

14. Open questions

None beyond those stated.

15. Linked fact checks