ADM Partners with University of Oxford to Study Link Between Gut Microbiome and Emotional and Cognitive Wellbeing in Women During Early Menopause

• New research partnership will explore emotional and cognitive effects of probiotics in perimenopausal women

• Research to further the growing body of evidence on the effects of probiotics on mood and cognition and their ability to positively affect menopausal symptoms

ROLLE-ADM (NYSE: ADM), a leader in microbiome research and solutions, has announced the start of a clinical study in partnership with the University of Oxford evaluating the effects of a probiotic supplement in women who are in perimenopause. The research seeks to provide a deeper understanding of the links between the gut microbiome and the emotional and cognitive changes occurring during this period.

The eight-week trial, which has enrolled its first volunteer, will focus on the emotional and cognitive effects of a probiotic supplement containing 14 live bacterial strains in 106 perimenopausal women, building on existing evidence for this combination of probiotics on mood and cognitive and emotional processing. The study is a randomised, double-blind, placebo-controlled study with volunteers randomised to receive either the probiotic or placebo. The emotional processing, cognitive function, subjective mood ratings and faecal microbiome of individuals taking part in the trial will be measured before and after taking the investigational products (the commercially available probiotic or the placebo).

The transition to menopause¹ also referred to as the 'perimenopause' can be a gradual process, usually beginning with changes in the menstrual cycle. The perimenopause period can last for several years and impact a woman's physical, emotional and mental wellbeing. Studies have shown that women are two to five times more likely² to experience depression³ during menopause compared with the time period before perimenopause. Worsened cognitive function⁴, particularly memory performance, is also common during this time.

Richard Day, Vice President of Medical Affairs R&D Health & Wellness at ADM said: "We are delighted to be partnering with the University of Oxford again, and to have initiated this study, which aims to fill a gap in knowledge about the role of the microbiome in menopause. Better understanding this link could help lead to new interventions to alleviate what can be debilitating symptoms for perimenopausal and menopausal women."

Professor Phil Burnet from the University of Oxford's Department of Psychiatry said: "We and others have provided compelling evidence for the psychotropic effects of probiotics in humans, and recent studies have demonstrated that probiotics can ameliorate some symptoms of menopause in female volunteers. This new study aims to build on that growing body of evidence."

This new trial builds on the 2022 collaboration between ADM and the University of Oxford, in which a clinical study⁵ was conducted to assess the role of the same probiotic supplement in healthy adults with self-reported low mood. The study found that consuming ADM's 14-strain probiotic supplement for a period of four weeks can decrease self-reported low mood scores by 47%.

The recruitment phase of the new study in women who are in perimenopause is planned to run until summer 2027, with headline results expected in spring 2028.

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1World Health Organization, Menopause fact sheet (October 2024), https://www.who.int/news-room/fact-sheets/detail/menopause

²Depression During and After the Perimenopause: Impact of Hormones, Genetics, and Environmental Determinants of Disease. Bromberger & Epperson. Obstet Gynecol Clin North Am. 2018 Dec;45(4):663-678

³Cognition and mood in perimenopause: a systematic review and meta-analysis. Weber, M. T., Maki, P. M., & McDermott, M. P. (2014). The Journal of steroid biochemistry and molecular biology, 142, 90-98. https://doi.org/10.1016/j.jsbmb.2013.06.001

⁴Menopause and cognitive impairment: A narrative review of current knowledge. Conde et al (2021). World J Psychiatry. 11(8):412-428

⁵Multispecies probiotic administration reduces emotional salience and improves mood in subjects with moderate depression: a randomised, double-blind, placebo-controlled study. Baião et al. Psychol Med. 2022 Feb 7;53(8):3437-3447

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