Yeast Beta-Glucan Supplementation with Multivitamins Attenuates Cognitive Impairments in [ME/CFS], 2023, Lacasa et al

[Joan Crawford]

Yeast Beta-Glucan Supplementation with Multivitamins Attenuates Cognitive Impairments in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

https://www.mdpi.com/2532610

Marcos Lacasa et al

Open Access

Abstract

This research aimed to examine the potential alleviative effects of beta-glucan administration on fatigue, unrefreshing sleep, anxiety/depression symptoms and health-related quality of life in ME/CFS. A 36-week unicenter, randomized, double-blind, placebo-controlled trial was conducted in 65 ME/CFS patients, who were randomly allocated to one of two arms to receive four capsules each one of 250 mg beta-glucan, 3.75 µg vitamin D3, 1.05 mg vitamin B6, and 7.5 mg zinc (n = 35), or matching placebo including only microcrystalline cellulose as an excipient (n = 30) once daily. The findings showed that the beta-glucan supplementation significantly improved cognitive fatigue (assessed with FIS-40 scores) after the 36-week treatment compared to the baseline (p = 0.0338). Taken together, this study presents the novel finding that yeast-derived beta-glucan may alleviate cognitive fatigue symptoms in ME/CFS. Thus, it offers valuable scientific insights into the potential use of yeast beta-glucan as a nutritional supplement and/or functional food to prevent or reduce cognitive dysfunction in patients with ME/CFS. Further interventions are warranted to validate these findings and also to delve deeper into the possible immunometabolic pathomechanisms of beta-glucans in ME/CFS.

Keywords: chronic fatigue syndrome; beta-glucan; zinc; vitamin D3; vitamin B6; myalgic encephalomyelitis; mitochondria; non-restorative sleep; quality of life

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On brief skim read over - lots of bold claims re cognitive functioning (....attenuates cognitive impairments....) but no use of objective cognitive testing. Also, subjective outcomes measures used too. Bit of a wasted opportunity.

Cognitive Impairment has a specific meaning in neuropsychological assessment. Here they did not do appropriate, rigorous neuropsychological assessment and then claimed it worked - also without any re-assessment! Bold claims require good quality objective evidence. They also mix up cognitive dysfunction and cognitive impairment - these are not the same thing. I suspect no input from psychologist / neuropsychologist.

 

[EndME]

Patients were potentially eligible for the study if they were female, aged 18 years or older, and had a confirmed diagnosis of ME/CFS according to the 1994 CDC/Fukuda case definition

 

[Jaybee00]

Conflicts of Interest
L.V. is an employee of VITAE Health Innovation S.L. (Montmeló, Barcelona, Spain). As stated in the author contributions, the funders declare that they had no role in the design, execution, analysis and interpretation, and presentation of data. J.C.-M. received financial support from VITAE Health Innovation S.L. to conduct this intervention study. The rest of the authors declare no conflicts of interest.

 

[Hutan]

We've seen dodgy papers from Castro-Marrero's lab (click on the tab top left) - it seems to be a bit of a factory for producing papers on supplements for diseases that have no useful treatments.

Maybe there is something real here but I wouldn't bet on it.

 

[NelliePledge]

Beta glucan is pretty easily accessible in the diet don’t know other than as a money spinner what the point of taking supplements would be.

 

[Wonko]

It's basically marketing by BigOat to try and sell more porridge oats

 

[Hutan]

Beta glucan is pretty easily accessible in the diet don’t know other than as a money spinner what the point of taking supplements would be.

It's marketing by BigOat to try and sell more porridge oats.

One and a half cups of cooked oatmeal or three packets of instant oatmeal are reported to provide 3 g of beta-glucans. Intakes of around that much are regarded as good for heart health.

This trial had participants receiving 250 mg of beta-glucan daily. So, I make that the equivalent of 4 (flat) tablespoons of cooked porridge. It's also the equivalent of half a slice of bread (1.5g in 100g of bread, 3 slices of bread in 100g). So, this amount of beta-glucan is insignificant in anyone having an even vaguely normal diet.

Good sources include
oats, barley, sorghum, rye, maize, triticale, wheat, durum wheat, rice, mushrooms, seaweed

We've seen Castro-Marrero do this thing of bundling up the supplements (throwing in vitamins and zinc in this case). So, even if something did really work, we wouldn't know what was helping.

 

[cassava7]

It's basically marketing by BigOat to try and sell more porridge oats

@JohnTheJack would surely approve!

 

[NelliePledge]

Oat bran is the best source. It is even allowed to print health claims on the packaging

 

[Trish]

The claim in the article title is ridiculous. The data come from the FIS-40 fatigue questionnaire which divides into domains:
cognitive, psychosocial, physical functioning, and total.

If you look at table 2, the only one that showed slightly statistically significant change between before and after scores was the cognitive domain for the active arm.

Active arm (n = 29) Cognitive before 33.31 ± 7.03 after 31.45 ± 9.7

Placebo Cognitive before 33.82 ± 5.42 after 32.73 ± 5.7

So the active arm improved by 1.86, and the placebo arm improved by 1.09
giving a difference in improvement between the groups of 0.77
I bet that's not a significant between group difference.
The stat they used to claim it worked was the 1.86 improvement in the treatment group, so they took no notice of the fact that the placebo group improved too.

The also claim that
"It should be noted that a cognition improvement found through percentage differences of 5.7% in active arm is more likely to be due to a real treatment effect using beta-glucans plus multivitamins among the participants."

The 5.7% is calculated by dividing the improvement in average cognitive fatigue score for the treatment group: 1.86/33.31
That seems to me to be meaningless.
The same calculation for the placebo group would give 1.07/33.82 = 3.2%

 

[Andy]

@JohnTheJack would surely approve!

From one of his tweets recently, where he reported ordering and receiving large quantities, I suspect that he might be part of BigOat himself.

 

[JohnTheJack]

@JohnTheJack would surely approve!

Hehe. Definitely.

 

[forestglip]

A comment on PubPeer has some similar criticisms as what @Trish said.

This paper concludes that yeast beta-glucan "improves indices of cognition function with major beneficial effects..." based on the within-group (ie baseline to week 36) change in the treated group for the cognitive domain of the FIS-40 score.

There are a number of major issues with the reporting of the results in this paper:

1. Concluding solely on the within-group difference for the active arm defeats the point of conducting a placebo-controlled randomised trial.
   
   
2. The preregistered primary endpoint (https://clinicaltrials.gov/study/NCT04301609) was FIS-40 score. It is ambiguous as to whether total score was the endpoint, but this seems a logical supposition. Regardless, the cognitive domain of FIS-40 was not the primary endpoint.
   
   
3. The within-group (baseline to week 36) improvement in total FIS-40 score was numerically greater in the placebo arm than in the treatment arm.
   
   
4. Between-group comparisons are not presented for overall FIS-40 score or any of the subdomain scores. The authors should present these here.
   

On the basis of the evidence presented in the paper, there is no good evidence to suggest that yeast beta-glucan is more effective than placebo for improving fatigue.