The role of probiotics on the quality of sleep

Clinical studies in Atlantia have conceived and carried out a human clinical study to evaluate the result of probiotic supplementation in the quality of sleep and its implications on immunity. The details of such a study are presented in this article.

Recent Studies have shown that the wrong clock of the circadian clock, sleep deprivation And the experience of change can change the expression of the circadian watch gene and the structure of the microbial community.

Sleep disorders/loss contributes significantly to cognitive deficiency, affective interruption and physical disease, thus, the development of safe and effective treatments for disturbed sleep is a high public priority.

Challenges and goals

The results derived from this work are well positioned to benefit the company, offering a deeper understanding of the role of the microbiota-gut-brain in sleep.

In general, the relationship between probiotics and sleep is still wrongly conceived.

This is due to the lack of data from large -scale clinical trials that have the valuable effects of probiotics in improving the quality of sleep in the general population, as well as if immune, metabolic and stress biomarkers differ from person to person with poor sleep quality.

Image Credit: Clinical Studies in Atlantia

The requirements of the sponsor required a reliable partner, with the ability to access an adequate study population and sufficient expertise to develop and perform a standard gold process with probiotics to evaluate changes:

• Objective sleep quality such as sleep latency, efficiency and wake -up episodes
• Self-reported physical and mental health, blood biomarkers, including inflammatory, hormonal, tryptophan and metabolic markers.

How did the atlantic solution help

The elite team of doctors, scientists, nutritionists and research assistants in Atlantia has worked in close collaboration with sponsor researchers to design and offer the main objectives of the study.

The team of experts from Atlantia, who specializes in sleep, stress and knowledge were an ideal match for the research needs of the sponsor – his expertise in measuring sleep with the combination of objective and subjective evaluations were leading factors in pursuing this project.

About study

The study was conducted as a randomized, double-blind, placebo-controlled parallel, developed to evaluate the effectiveness and safety of a probiotic stem The quality of sleep When consumed once a day.

Image Credit: Clinical Studies in Atlantia

8 -week intervention study was done using subjects who were otherwise healthy, using Pittsburgh sleep quality index (PSQI), Hads-A and Had-D, as it is established by the inclusion criteria. The subjects were recruited by the Atlantic database, the general doctor’s offices, the socializing platforms and advertisements posted in the local newspapers.

Initially, the subjects were subjected to online screening and were asked to complete general questions to establish their eligibility.

Once established, the eligible subjects were contacted by E -Email and received a link to complete five questionnaires: Pittsburgh (PSQI) sleep quality index, hospital anxiety and depression (HADS), short form 36 (SF36), insomnia index for sleep (ISI) and stress scale (PSS).

These questionnaires were subsequently evaluated and, if the eligibility criteria were met, the subject was invited to participate in a screening visit in person. This was conceived as a study with a single center, with subjects to be recruited by clinical studies in Atlantia.

During a 10 -week period, the subjects participated in clinical visits, and during the study, each subject wore an actigraph to measure sleep latency, sleep efficiency, waking episodes and waking up after the onset of sleep.

In addition, the subjects were forced to record their daily quality of sleep, rejuvenation upon awakening and nocturnal awakening (WASO).

The subjects were advised to follow their normal diet and do physical exercises and not to consume prohibited medicines, dietary supplements and/or probiotic products that could have an influence on the basic features of the study during the evaluation and screening period.

About clinical studies in Atlantia

Clinical Study LTD atlantia It is a specialized tree in conducting studies in food, drinks and supplements for worldwide companies that want to scientifically validate their functional ingredients to support a health request (EFSA (food safety authority); Claiming the function of the FDA structure (food and drugs); or general product marketing demand.

Atlantia works with world scientists (among the first 1% quotes at international level, in the fields of digestive health and functional foods) at: APC Microbiome Institute in University College Cork, Ireland; Teagasc, Moorepark, Ireland and Centers of Excellence recognized globally.

Atlanty leads and operates its own clinical sites and performs all studies to the ICH -GCP standard (International Council for Harmonizing Technical Requirements for Human Use -a good clinical practice). His team includes medical experts in digestive health, mental health (psychological stress and cognition), cardiovascular health, sports performance, metabolic disease, bone health, immune health and healthy aging. The clinic team also includes project managers, nurses, nutritionists, certified sports coaches and laboratory researchers.

Atlanty manages all the elements from the design of the protocol, the manufacture of placebo, the recruitment and execution of the study, until the sample and data analysis, the statistics and the report/preparation of the file to provide a service that is technically, scientific and clinical.

Clinical studies cover a broad spectrum of functional categories of food and drinks, such as dairy, cereals, probiotics, different protein forms, baby/minerals specific foods, herbal or marine extracts and medical foods.

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