Evidence map›Paper›PMID 35297784›Full record

ReviewThe American journal of gastroenterology2022

Optimal Design of Clinical Trials of Dietary Interventions in Disorders of Gut-Brain Interaction.

Heidi M Staudacher, Chu Kion Yao, William D Chey, Kevin Whelan

Open access · hybridAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The American journal of gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 6 pooled it
4.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 6 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. British Dietetic Association Guidelines for the Dietary Management of Chronic Constipation in Adults.Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · 2025
    Guideline
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. The Challenges of Performing Controlled Trials of Diet Therapies in Gastroenterology.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
  15. Observational
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 3 countries.

Heidi M StaudacherDeakin University, IMPACT (Institute for Mental and Physical Health and Clinical Translation), Food & Mood Centre, Geelong, VIC, Australia.ORCID 0000-0001-6704-2131
Chu Kion YaoMonash University and Alfred Health, Melbourne, Victoria, Australia.
William D CheyDivision of Gastroenterology, Michigan Medicine, Ann Arbor, Michigan, USA.
Kevin WhelanDepartment of Nutritional Sciences, King's College London, London, United Kingdom.
Alfred Health · AUDeakin University · AUKing's College London · GBMichigan Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is accumulating evidence for the fundamental role of diet in the integrated care of disorders of gut-brain interaction. Food is a complex mixture of components with individual, synergistic, and antagonistic effects, compared with the relative purity of a pharmaceutical. Food is also an inherent part of individuals' daily lives, and food choice is strongly tied to food preferences, personal beliefs, cultural and religious practices, and economic status, which can influence its ability to function as a therapeutic intervention. Hence, randomized controlled trials of dietary interventions carry unique methodological complexities that are not applicable to pharmaceutical trials that if disregarded can pose significant risk to trial quality. The challenges of designing and delivering the dietary intervention depend on the type of intervention (i.e., nutrient vs food supplementation or whole-diet intervention). Furthermore, there are multiple modes of delivery of dietary interventions, each with their own advantages (e.g., the high precision of feeding trials and the strong clinical applicability of dietary counseling trials). Randomized placebo-controlled trials of dietary interventions are possible with sufficient attention to their design and methodological nuances. Collaboration with experts in nutrition and dietetics is essential for the planning phase; however, even with expert input, not all challenges can be overcome. Researchers undertaking future dietary trials must be transparent in reporting these challenges and approaches for overcoming them. This review aims to provide guiding principles and recommendations for addressing these challenges to facilitate the conduct and reporting of high-quality trials that inform and improve clinical practice.

Indexed as

DietDieteticsBrainHumansNutritional StatusPharmaceutical PreparationsPharmaceutical Preparations

Identifiers

PMID35297784
PMCPMC9169766
OpenAlexW4220885946

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.