Atlantia Clinical Trials designed and carried out a human clinical trial to assess the outcome of probiotic supplementation in sleep quality and its implications on immunity. The details of such a study are outlined in this article.
Recent studies have demonstrated that circadian clock misalignment, sleep deprivation and shift experience may alter the circadian clock gene expression and microbial community structure.
Sleep disturbance/loss significantly contributes to cognitive impairment, affective disruption, and physical disease, thus, developing safe and effective treatments for disturbed sleep is a high public priority.
Challenges and objectives
The results deriving from this work are well-positioned to benefit society by offering a deeper understanding of the role of the microbiota-gut-brain axis in sleep.
On the whole, the relationship between probiotics and sleep is still misconceived.
This is due to a lack of data from large-scale clinical trials depicting the valuable effects of probiotics in improving sleep quality in the general population, as well as whether immune, metabolic and stress-related biomarkers differ considerably from person to person with poor sleep quality.
Image Credit: Atlantia Clinical Trials
The sponsor’s requirements necessitated a trusted partner with the capacity to access an appropriate study population and sufficient expertise to develop and conduct a gold-standard trial with probiotics to evaluate changes in:
- Objective sleep quality, such as sleep latency, efficiency and waking episodes
- Self-reported physical and mental health, blood biomarkers including inflammatory, hormonal, tryptophan and metabolic markers.
How Atlantia’s solution helped
Atlantia’s elite team of doctors, scientists, nutritionists and research nurses worked in close collaboration with the sponsor’s researchers to design and deliver the main objectives of the study.
Atlantia’s team of experts who specialize in sleep, stress and cognition were an ideal match for the sponsor’s research needs – its expertise in measuring sleep with the combination of objective and subjective assessments were leading factors in the pursuit of this project.
About the study
The study was conducted as a randomized, double-blind, placebo-controlled, parallel group study, developed to evaluate the effectiveness and safety of a probiotic strain on sleep quality when consumed once a day.
Image Credit: Atlantia Clinical Trials
The 8-week intervention study was carried out using subjects that were otherwise healthy, utilizing the Pittsburgh Sleep Quality Index (PSQI), HADS-A, and HAD-D as established by the inclusion criteria. Subjects were recruited through Atlantia’s database, general practitioner’s offices, social media platforms and adverts posted in local newspapers.
Subjects were initially subjected to an on-line screening and were asked to complete general questions to establish their eligibility.
Once established, the eligible subjects were contacted via email and given a link to complete five questionnaires: the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), the Short Form 36 (SF36), the Insomnia Sleep Index (ISI) and Perceived Stress Scale (PSS).
These questionnaires were subsequently evaluated, and if the eligibility criteria were met, the subject was invited to attend an in-person screening visit. This was devised as a single-center study, with subjects to be recruited by Atlantia Clinical Trials.
Over a 10-week period, subjects attended clinical visits, and throughout the study, each subject wore an Actigraph to measure sleep latency, sleep efficiency, wake episodes and wake time after sleep onset.
Additionally, subjects were required to record their daily sleep quality, rejuvenated-ness on waking and night-time waking (WASO).
Subjects were advised to follow their normal diet and exercise routine and not to consume any prohibited medications, dietary supplements and/or probiotic products that could have an influence on the study participants’ baseline characteristics during the evaluation and screening period.
About Atlantia Clinical Trials
Atlantia Clinical Trials Ltd is a CRO that specializes in conducting studies in foods, beverages and supplements for companies world-wide that want to scientifically validate their functional ingredients to support an: EFSA (European Food Safety Authority) Health Claim; FDA (Food & Drug Administration) Structure Function Claim; or General Product Marketing Claim.
Atlantia works with world leading scientists (among the top cited 1% internationally, in the areas of digestive health and functional foods) at the: APC Microbiome Institute in University College Cork, Ireland; Teagasc, Moorepark, Ireland and recognized centers of excellence globally.
Atlantia runs and operates its own clinic sites and conducts all studies to ICH-GCP standard (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice). Its team includes physician experts in digestive health, mental health (psychological stress and cognition), cardiovascular health, sports performance, metabolic disease, bone health, immune health and healthy ageing. The clinical team also includes project managers, research nurses, nutritionists, certified sports trainers and lab researchers.
Atlantia manages all elements from protocol design, placebo manufacture, recruitment, and study execution, to sample and data analysis, statistics and report/dossier preparation to provide a service which is technically, scientifically and clinically superior.
The clinical studies cover a broad spectrum of functional food and beverage categories, such as dairy, cereal, probiotic, different protein forms, infant-specific foods, vitamins/minerals, plant or marine extracts and medical foods.
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