Sufficient, high-quality sleep is essential for health, mental wellbeing, cognitive abilities, and more. But the strains of daily life can prevent people from enjoying a good night’s rest: stress in general, the use of smart phones and other electronic devices, caffeine intake and other elements can all have an impact.
The far-ranging effects of insufficient sleep range from an increased risk of several metabolic health issues such as diabetes mellitus and weight problems, to behavioural changes such as decreased awareness and increased depression.
More and more, consumers are looking for ‘natural’ solutions to help them improve their health and wellbeing, including through better sleep. There is increasing evidence that a healthy gut microbiome, and especially the presence of adequate levels of bifidobacteria and lactobacilli, can improve sleep quality and decrease stress. Developing a product that promotes these bacteria in the gut can therefore be potentially interesting for food, drink and supplement manufacturers looking to deliver clinically proven solutions that respond to the consumer demand for health benefits.
FrieslandCampina Ingredients wanted to demonstrate the benefits of its innovative Biotis™ SleepWell concept to reduce stress and provide better sleep in healthy adults. The product contains galacto-oligosaccharides, dairy protein-derived amino acids, vitamins and minerals.
NIZO carried out a double-blind, randomised, placebo-controlled clinical trial at its own, in-house facilities. The customised study followed good clinical practice (GCP) standards, with 70 adults aged 30-50 who self-reported moderate sleep disturbances.
Participants started by reporting a baseline for their level of sleep disturbance, using the ‘standard’, validated Pittsburgh Sleep Quality Index (PSQI) questionnaire. They then received a daily dose of either the product or a placebo for three weeks. During that period, they retook the PSQI questionnaire, to reveal any evolution in sleep quantity and quality.
The study showed that participants who had poorer sleep at the beginning (specifically a PSQI score of ≥9), saw real improvements in sleep quality after taking the Biotis™ for 14 days, compared to those taking the placebo.
In addition to the PSQI questionnaire, faecal samples were collected to evaluate gut microbiota composition. Using 16S rRNA gene sequencing, NIZO compared the gut microbiota from before and after the participants began using the Biotis™SleepWell.
Using statistical testing, interpretation and visualisation of the results, NIZO showed that participants taking the product (rather than the placebo) had greater levels of Bifidobacterium, which previously has been linked to improved sleep quality. Furthermore, our analyses provided further evidence of the link between the gut microbiome and mental wellbeing.
NIZO’s multidisciplinary, science-based approach to health benefit substantiation allows a thorough assessment of the health impact of specific ingredients, compounds or foods, starting from any point in the product journey. We combine deep nutrition, clinical and microbiome expertise with well-designed clinical trials, biomarker analysis and expert interpretation. This allows us to go beyond delivering a report, and offer customised advice on a broad range of topics: study design, potential benefits, the regulatory environment, or strategic advice on developing a comprehensive development plan for your product or ingredient, to name only a few possibilities.