Randomised controlled trialindependent cross-checkabstract checked★ key study I-WHT-116 in-depth review

Refined wheat raised liver fat compared with whole-grain wheat

A 12-wk whole-grain wheat intervention protects against hepatic fat: the Graandioos study, a randomized trial in overweight subjects.

Overview

Schutte S et al.. Am J Clin Nutr 2018 · PMID 30541093 · DOI 10.1093/ajcn/nqy204

In 50 overweight adults, 12 weeks of refined wheat products increased liver fat by 49% relative to whole-grain wheat.

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

Original publication

Plain-language summary

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

Wheat type and liver fat.

How was the study done?

Double-blind RCT.

How many people, animals or samples were studied?

50 adults.

What was actually found?

Liver fat rose with refined wheat.

How large was the observed effect?

+49.1% relative.

What do the results mean in everyday life?

Choosing whole-grain wheat may protect the liver.

What are the study's limitations?

Small, short.

What does it say about Elawady's specific claim?

Supports a link between refined flour and liver fat.

Do the results apply to Germany and Europe?

High.

What can explicitly not be concluded from this study?

Cannot show that white flour causes fatty liver disease.

Scientific in-depth review

1. Full reference

Authors
Schutte S et al.
Journal
Am J Clin Nutr
Year
2018
Identifier
PMID 30541093 DOI 10.1093/ajcn/nqy204
Verification
verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Does whole-grain wheat vs refined wheat affect liver fat?

3. Study design and population

Study design
Randomised controlled trial – Double-blind randomised parallel trial (Graandioos study)
Population

Overweight men and postmenopausal women aged 45-70

Country

not stated in abstract

Period

not stated in abstract

Sample size

50

Inclusion and exclusion criteria

Overweight, 45-70 years

4. Methods and endpoints

Exposure / intervention

Whole-grain wheat products 98 g/day for 12 weeks

Comparator

Refined wheat products 98 g/day

Endpoints

Intrahepatic triglycerides (1H-MRS), fat distribution, microbiota, plasma markers

Statistical methods

Between-group comparisons

5. Actual results

Results

Intrahepatic triglycerides increased by 49.1% in the refined wheat group compared with the whole-grain wheat group (P=0.033). Fasting lipids and insulin unchanged. Microbiota diversity decreased with refined wheat (P=0.010). Postprandial triglycerides higher with whole-grain wheat (P=0.020).

Absolute risks

not reported

Authors' conclusion

A 12-week refined wheat intervention increases liver fat; 98 g/day whole-grain wheat prevents this increase.

6. Strengths

  • Double-blind
  • MRS-measured liver fat
  • Registered NCT02385149

7. Weaknesses

  • Small (n=50)
  • 12 weeks
  • Surrogate outcome
  • Funding not stated in the abstract

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

Small trial; single significant primary-type finding (P=0.033).

9. Assessment of the statistical interpretation

Relative difference in liver fat; absolute values not in abstract, so recalculation impossible.

10. Relevance to the specific claim

First randomised evidence that refined wheat (vs whole-grain wheat) increases liver fat.

11. Independent contrary findings

I-WHT-05 (observational null).

12. Transferability to Germany and Europe

High.

13. Overall methodological judgement

Small but direct RCT support.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualitymoderate
Risk of biassome concerns
Precision of resultslow
Directnessdirect
Reproducibilitynot replicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Replication; clinical NAFLD outcomes.

15. Linked fact checks