Evidence map›Paper›PMID 34715934›Full record

ArticlePilot and feasibility studies2021

Ergothioneine supplementation in people with metabolic syndrome (ErgMS): protocol for a randomised, double-blind, placebo-controlled pilot study.

Xiaoying Tian, Giorgia Cioccoloni, Joanna H Sier, Khalid M Naseem, James L Thorne, J Bernadette Moore

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

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05896878 (The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 22% 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.

NCT05896878 naterminatednot on this mapstarted 2023, after this paper: background citation

The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients

TypeinterventionalSponsorHudson MedicalRan2023 to 2024Enrolled1ConditionsPain, Chronic, Opioid Dependence, Opioid Use, Inflammation ChronicArmsRoot.Health Dietary Supplement
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Nutraceuticals as Modulators of Autophagy: Relevance in Parkinson's Disease.International journal of molecular sciences · 2022
    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 1 institution in 1 country.

Xiaoying TianSchool of Food Science & Nutrition, University of Leeds, Leeds, LS2 9JT, UK.
Giorgia CioccoloniSchool of Food Science & Nutrition, University of Leeds, Leeds, LS2 9JT, UK.
Joanna H SierSchool of Food Science & Nutrition, University of Leeds, Leeds, LS2 9JT, UK.
Khalid M NaseemLeeds Institute of Cardiovascular & Metabolic Medicine, University of Leeds, Leeds, LS2 9JT, UK.
James L ThorneSchool of Food Science & Nutrition, University of Leeds, Leeds, LS2 9JT, UK.
J Bernadette MooreSchool of Food Science & Nutrition, University of Leeds, Leeds, LS2 9JT, UK. J.B.Moore@leeds.ac.uk.ORCID http://orcid.org/0000-0003-4750-1550
University of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundErgothioneine is a naturally occurring metabolite of histidine found in many foods and in high amounts in mushrooms. In vivo, ergothioneine acts as an antioxidant and is widely distributed in most mammalian tissues. While ergothioneine is sold as a dietary supplement for its antioxidant and anti-inflammatory properties, to date there are no published intervention trials examining its health benefits in humans. The aim of this work was to develop a study protocol for a pilot interventional trial that will establish the primary and secondary outcomes, and the power required, for a definitive randomised controlled trial to test the hypothesis that ergothioneine supplementation is beneficial for people with metabolic syndrome.

methodsWe have designed the ErgMS study as a single-centre, randomised, double-blind, placebo-controlled, 3-arm parallel, pilot intervention trial, which aims to supplement participants with either placebo, 5 or 30 mg/day ergothioneine for 12 weeks. Measurements of metabolic syndrome risk factors, serum markers of oxidative stress (lipid peroxidation), inflammation, blood platelet function and liver function will take place at baseline, and after 6 weeks and 12 weeks of supplementation. In addition, we will examine if there are any changes in the serum metabolome in response to ergothioneine supplementation. Linear regression and two-way ANOVA will be utilised to analyse the association between ergothioneine and measured variables. DISCUSSION: The ErgMS study will be the first study to address the question does ergothioneine supplementation have health benefits for people with metabolic syndrome. Study results will provide preliminary data as to which dose may improve inflammatory markers in adults with metabolic syndrome and will inform dose and primary outcome selection for a definitive randomised controlled trial.

trial registrationISRCTN, ISRCTN25890011 Registered February 10

Indexed as

ALTErgothioneineInflammationMetabolic syndromeMetabolomeOxidative stressSupplementation

Identifiers

PMID34715934
PMCPMC8555363
OpenAlexW3208849867

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.