Effects of Probiotic NVP-1704 on Mental Health and Sleep in Healthy Adults: An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial.

Hyuk Joo Lee, Jung Kyung Hong, Jeon-Kyung Kim, Dong-Hyun Kim, Seok Won Jang, Seung-Won Han, In-Young Yoon

Journal: Nutrients 2021;13(8):2660

PMID: 34444820

Plain Language Summary

Dietary changes directly alter the gut microbiome composition. A diversified gut microbiome may have therapeutic implications for mental health, and specific strains of probiotics have shown the potential to treat depression and anxiety. Several preclinical trials have found the probiotic mixture NVP-1704 to alleviate depression and anxiety in mice through modulating the gut-brain-microbiome axis. The aim of this randomised, double-blind, placebo-controlled, parallel study was to examine the efficacy and safety of NVP-1704 for the management of depression, anxiety and insomnia in healthy adults. A total of 156 healthy adults with subclinical depression, anxiety and insomnia were randomised to receive either NVP-1704 or placebo for eight weeks. Participants completed various questionnaires and biomarkers of stress and inflammation were assessed. After eight weeks, this study found that NVP-1704 to be a safe and well-tolerated probiotic with beneficial effects on depression, sleep quality, inflammation and gut microbiome composition in healthy adults. Based on this study, the authors conclude the therapeutic effects of NVP-1704 previously found in preclinical mice trials may now be translated to clinical trials. The authors suggest large, highly controlled, longitudinal human studies be conducted in the future to further confirm the benefits of probiotics on mental health and sleep.

Abstract

["The human gut microbiome is closely linked to mental health and sleep. We aimed to verify the efficacy and safety of probiotic NVP-1704, a mixture of NK33 and NK98, in improving stress, depression, anxiety, and sleep disturbances, along with the measurement of some blood biomarkers. A total of 156 healthy adults with subclinical symptoms of depression, anxiety, and insomnia were retrospectively registered and randomly assigned to receive either NVP-1704 ( = 78) or a placebo ( = 78) for eight weeks. Participants completed the Stress Response Inventory, Beck's Depression and Anxiety Inventory, Pittsburg Sleep Quality Index, and Insomnia Severity Index at baseline, at four and eight weeks of treatment. Pre- and post-treatment blood tests for biomarkers were conducted. After intervention, gut microbiota composition was quantified by pyrosequencing the bacterial 16S rRNA gene. The NVP-1704 group had a more significant reduction in depressive symptoms at four and eight weeks of treatment, and anxiety symptoms at four weeks compared to the placebo group. Those receiving NVP-1704 also experienced an improvement in sleep quality. NVP-1704 treatment led to a decrease in serum interleukin-6 levels. Furthermore, NVP-1704 increased and , whereas it decreased in the gut microbiota composition. Our findings suggest that probiotic NVP-1704 could be beneficial for mental health and sleep."]

Address: Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University, Gyeonggi 11759, Korea.; Department of Neuropsychiatry, School of Medicine, Eulji University, Daejeon 34824, Korea.; Department of Psychiatry, Bundang Hospital, Seoul National University, Seongnam 13620, Korea.; Neurobiota Research Center, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.; PB Department, Navipharm Inc., Suwon 16209, Korea.; Department of Psychiatry, School of Medicine, Seoul National University, Seoul 03080, Korea.

DOI: 10.3390/nu13082660

Patient Centred Factor

Mediators: Probiotics

Physical Environment

Infectious Agents

Clinical Imbalances

Neurological Gastro-intestinal

Laboratory Testing

Blood Stool Urine

Modifiable Lifestyle Factors

Diet Stress, Relaxation, Resilience

Jadad Score

Allocation Concealment

Yes

Nutrition Evidence Keywords

Dysbiosis HPA axis Placebo effect Hypothalamic–pituitary–adrenal axis Stress Response Inventory Beck Depression Inventory-II Pittsburgh Sleep Quality Index (PSQI) Insomnia Severity Index

Bioactive Substances

Lactobacillus reuteri IL-6 Interleukin 6 NVP-1704 NK33 Bifidobacterium adolescentis NK98

Link outs

Free resources

Full Text Sources:

Medical:

https://medlineplus.gov/mentalhealth.html

MeSH Terms: Adult, Aged, Anxiety, Bifidobacterium adolescentis, Biomarkers, Depression, Double-Blind Method, Female, Gastrointestinal Microbiome, Humans, Limosilactobacillus reuteri, Male, Mental Health, Middle Aged, Probiotics, RNA, Ribosomal, 16S, Sleep, Surveys and Questionnaires, Young Adult