The combination of Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 has been studied since 2008 when a study [Diop et al. Nutrition Research, Vol. 28, No. 1, pp. 1-5] showed efficacy on stress-induced gastrointestinal symptoms. This was followed by a gold-standard study [Messaoudi et al. 2010 British Journal of Nutrition, Vol. 105, No. 5, pp. 755-764] with 55 healthy volunteers, which demonstrated a significant reduction of psychological stress as assessed by a validated questionnaire.
“These findings led to official recognition from Canadian and Brazilian health authorities. CereBiome is the first and only psychobiotic with specific approved health claims on mood and stress. This recognition from competent authorities adds tremendous value and indicates that the scientific evidences supporting this psychobiotic are robust, reliable and verifiable,” said Lucie Lingrand, Product Manager at Lallemand Health Solutions.
Subsequent studies with people with depression in 2017 [Romijn et al. Australian & New Zealand Journal of Psychiatry, Vol 51, No. 8, pp. 810-821] and 2019 [Kazemi et al. Clinical Nutrition, Vol. 38, No. 2, pp. 522-528] supported the combination’s ability to impact sleep and depression scores.
In the Kazemi study, the L. helveticus Rosell-52 and B. longum Rosell-175 group showed a decrease in the blood kynurenine/tryptophan ratio, which suggests that tryptophan was diverted toward the synthesis of serotonin and away from the inflammatory pathway (p<0.05).
Finally, data from an unpublished 2018 open-label study by Caroline Wallace at Queen’s University in Kingston, Canada found that in treatment-naïve patients, the probiotic combination was associated with positive effects on mood, anxiety, anhedonia and perceived stress, lasting up to eight weeks after treatment. This pilot study was used as a proof of concept for a larger, ongoing clinical trial that includes 108 participants diagnosed with depression.
According to Lallemand, recruitment for this clinical trial was planned to be completed by August 2020, but due to the current COVID-19 situation it has been delayed.
The protocol for the study was published in Neuropsychobiology [Wallace et al. 2020, Vol. 79, pp. 108–116], and it states that sleep will be assessed using polysomnography, while functional and structural neurophysiological changes will be measured using MRI. Blood, stool, and urine samples will also be obtained to measure cytokine levels and explore potential genes and proteins that may predict depression outcomes.
The state of the market
According to Lallemand, the global brain health supplements market is expected to reach US$11.6 billion by 2024, expanding with a compound annual growth rate (CAGR) of 19.6% from 2016 to 2024.
Data from the CRN 2019 Consumer Survey on Dietary Supplements indicated that up to 14% of US supplement users today take dietary supplements for brain health.