Evidence map›Paper›PMID 30659039›Full record

Trial reportBMJ open2019

Does intake of bread supplemented with wheat germ have a preventive role on cardiovascular disease risk markers in healthy volunteers? A randomised, controlled, crossover trial.

André Moreira-Rosário, Helder Pinheiro, Cláudia Marques, José António Teixeira, Conceição Calhau, Luís Filipe Azevedo

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02405507 (The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 32% 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.

NCT02405507 phase2completednot on this map

The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response in Healthy Volunteers

TypeinterventionalSponsorUniversidade do PortoRan2015 to 2017Enrolled55ConditionsHealthy VolunteersArmswheat bread with wheat germ, wheat bread without wheat germ
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. 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

6 authors at 5 institutions in 2 countries.

André Moreira-RosárioCentre for Health Technology and Services Research (CINTESIS), Porto, Portugal.
Helder PinheiroNutrition & Metabolism, NOVA University of Lisbon, NOVA Medical School, Lisbon, Portugal.
Cláudia MarquesCentre for Health Technology and Services Research (CINTESIS), Porto, Portugal.
José António TeixeiraCenter of Biological Engineering, University of Minho, Braga, Portugal.
Conceição CalhauCentre for Health Technology and Services Research (CINTESIS), Porto, Portugal.
Luís Filipe AzevedoCentre for Health Technology and Services Research (CINTESIS), Porto, Portugal.
Universidade do Porto · PTCentre for Health Technology and Services Research · PTNova Medical (United States) · USUniversity of Lisbon · PTUniversity of Minho · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIntake of whole grains is associated with a reduced risk of cardiovascular disease (CVD). This evidence is also strong for bran alone, but findings about germ are conflicting. Our aim was to elucidate the role of germ in primary prevention of cardiovascular events, and therefore, a staple food was selected for 6 g of germ supplementation. This corresponds to sixfold increase in the global mean consumption of germ, while preserving the sensory proprieties of refined bread which is crucial for consumer's acceptance.

designRandomised, double-blinded, crossover, controlled clinical trial with 15-week follow-up comprising a 2-week run-in, two intervention periods of 4 weeks each and a 5-week washout period.

settingA single centre in the north of Portugal.

participants55 eligible healthy adults (mean age of 34 years and body mass index between 19 and 38 kg/m

interventionsThe study consisted of two intervention periods including daily intake of refined wheat bread enriched with 6 g of wheat germ and control (non-enriched bread). OUTCOMES: Changes in fasting cholesterol and triglycerides, fasting and postprandial glucose, insulin sensitivity and C reactive protein.

resultsWe observed no significant effect of daily intake of wheat germ on cholesterol and triglycerides levels, on postprandial glucose response and on insulin sensitivity. Incremental area under curve glucose and homeostasis model assessment for insulin resistance did not change, suggesting that 6 g of wheat germ have no effect on glucose metabolism. No effect was also observed in the subgroup of participants who complied with the protocol (n=47).

conclusionsThe absence of alterations on lipid and glucose profiles suggests that germ up to 6 g/day may have no preventive effect on CVD risk. However, it is important to investigate other food vehicles that can accommodate higher doses of wheat germ in future studies. TRIAL REGISTRATION NUMBER: NCT02405507.

Indexed as

BreadTriticumWhole GrainsAdultBiomarkersBlood GlucoseCardiovascular DiseasesCholesterolCross-Over StudiesDouble-Blind MethodFemaleHumansMaleRecommended Dietary AllowancesTriglyceridesBiomarkersBlood GlucoseCholesterolTriglyceridescardiovascular riskglucose profilelipid profilerandomised controlled trialwheat germ

Identifiers

PMID30659039
PMCPMC6340436
OpenAlexW2909609714

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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.