Nutraceutical Capsules LL1 and Silymarin Supplementation Act on Mood and Sleep Quality Perception by Microbiota–Gut–Brain Axis: A Pilot Clinical Study

Author:

Santamarina Aline Boveto12ORCID,Nehmi Filho Victor12,Freitas Jéssica Alves de12ORCID,Franco Lucas Augusto Moysés3ORCID,Fonseca Joyce Vanessa4,Martins Roberta Cristina3,Turri José Antônio Orellana5ORCID,Silva Bruna Fernanda Rio Branco da16,Gusmão Arianne Fagotti7,Olivieri Eloísa Helena Ribeiro7,Otoch José Pinhata18,Pessoa Ana Flávia Marçal13

Affiliation:

1. Laboratório de Produtos e Derivados Naturais, Laboratório de Investigação Médica-26 (LIM-26), Departamento de Cirurgia, Faculdade de Medicina de São Paulo, Universidade de São Paulo, São Paulo 01246-903, SP, Brazil

2. Pesquisa e Desenvolvimento Efeom Nutrição S/A, São Paulo 03317-000, SP, Brazil

3. Laboratório de Parasitologia Médica (LIM-46), Departamento de Doenças Infecciosas e Parasitárias, Instituto de Medicina Tropical de São Paulo, Universidade de São Paulo, São Paulo 05403-000, SP, Brazil

4. Laboratório de Investigação Médica em Protozoologia, Bacteriologia e Resistência Antimicrobiana (LIM-49), Departamento de Doenças Infecciosas e Parasitárias, Instituto de Medicina Tropical de São Paulo, Universidade de São Paulo, São Paulo 05403-000, SP, Brazil

5. Grupo de Pesquisa em Economia da Saúde, Departamento de Ginecologia e Obstetrícia, Faculdade de Medicina, Universidade de São Paulo, São Paulo 01246-903, SP, Brazil

6. Laboratório Interdisciplinar em Fisiologia e Exercício, Universidade Federal de São Paulo (UNIFESP), Santos 11015-020, SP, Brazil

7. International Research Center, A.C. Camargo Cancer Center, São Paulo 01508-010, SP, Brazil

8. Hospital Universitário da Universidade de São Paulo, Faculdade de Medicina de São Paulo, Universidade de São Paulo, São Paulo 05508-000, SP, Brazil

Abstract

Stress, unhealthy lifestyle, and sleep disturbance worsen cognitive function in mood disorders, prompting a rise in the development of integrative health approaches. The recent investigations in the gut–brain axis field highlight the strong interplay among microbiota, inflammation, and mental health. Thus, this study aimed to investigate a new nutraceutical formulation comprising prebiotics, minerals, and silymarin’s impact on microbiota, inflammation, mood, and sleep quality. The study evaluated the LL1 + silymarin capsule supplementation over 180 days in overweight adults. We analyzed the fecal gut microbiota using partial 16S rRNA sequences, measured cytokine expression via CBA, collected anthropometric data, 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. 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. The supplementation tested in this study seems to be able to improve microbiota composition, reflecting anthropometrics and inflammation, as well as sleep quality and mood improvement.

Funder

Efeom Nutrition S.A.

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Publisher

MDPI AG

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