Writing in the journal Nutrients, the research team affiliated with the University of Sao Paulo and supplement company Efeom Nutrition reported findings from a pilot study on the effects of the novel combination supplement on microbiota, inflammation, mood and sleep quality in a group of overweight adults.
"The supplementation tested in this study seems to be able to improve microbiota composition, [reflected in] anthropometrics and inflammation, as well as sleep quality and mood improvement,” the researchers wrote.
Produced by Bioghen Suplementos Nutricionais in the Sao Paulo metropolitan area, the supplement is a combination of selenium, magnesium, zinc and chromium and GOS, FOS and beta-glucan (LL1 capsules) with added Silybum marianum L. Gaertn, also known as milk thistle.
The study was carried out with funding from Efeom Nutrition and the CAPES Foundation within the Brazilian Ministry of Education.
Disturbance and interplay along the gut-brain axis
The study highlighted the impact of stress, physical inactivity, overweight, unhealthy diet and resulting sleep disturbances on psychosocial dysfunction and lower quality of life, whether as part of generalized anxiety or major depressive disorder.
“An important factor to be considered is the gut microbiota because it regulates the production of essential factors for homeostasis, from inflammatory factors to neurotransmitters,” the researchers wrote. “Therefore, the development of nutraceutical formulas that seek to balance the intestinal environment represents a promising tool for balancing mood and promoting well-being.”
The formulation tested in the study was selected based on previous preclinical research that evaluated the effects of each component on metabolic, endocrine and microbiota modulation, compared with the LL1 individually and in combination with silymarin.
“These studies demonstrated that the LL1 blend, particularly when combined with silymarin, had superior effects on these parameters compared to the individual components,” the researcher noted. “Our research suggests that this enhanced efficacy may be due to nutrient synergy, which amplifies the beneficial effects on metabolism, endocrine function and microbiota.”
Study details
The study evaluated the effects of the LL1-sylymarin combination in a group of 22 participants with a BMI between 18.5 and 34.9 kg/m2 over a period of 180 days. It did not include a placebo group, noting that “traditional placebos like starch, resistant starch, cellulose, sugar and maltodextrin can interact with the gut microbiota” and thus are not ideal. Instead, a self-control design approach compared participant data before and after supplementation in a paired analysis.
Researchers analyzed participant fecal gut microbiota using partial 16S rRNA sequences, measured cytokine expression, collected anthropometric data and quality of life and sleep questionnaire responses, and obtained plasma samples for metabolic and hormonal analysis at baseline (T0) and 180 days (T180) post-supplementation.
“Our findings revealed significant reshaping in gut microbiota composition at the phylum, genus and species levels, especially in the butyrate-producer bacteria post-supplementation,” they reported. “These changes in gut microbiota were linked to enhancements in sleep quality, mood perception, cytokine expression and anthropometric measures, which microbiota-derived short-chain fatty acids might enhance.”
Of particular note was the increase in the Firmicutes phylum abundance, which has been found to be a relevant marker of gut dysbiosis in obese patients, the study noted, but also investigated as major producers of short-chain fatty acids (SCFAs), which help maintain barrier integrity and positively impact the central nervous system through the bloodstream.
Supplementation also increased abundance gut microbiota Actinobacteria, Bifidobacterium and Ruminococcus, which were associated with protective effects against major depressive disorder outcomes, improvements in sleep quality and anti-inflammatory effects.
Source: Nutrients
doi: 10.3390/nu16183049
“Nutraceutical Capsules LL1 and Silymarin Supplementation Act on Mood and Sleep Quality Perception by Microbiota–Gut–Brain Axis: A Pilot Clinical Study"
Authors: Aline Boveto Santamarina et al.
