Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      The study "Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia" is
      a part of a complex and multi-sectoral development research project (PROS.IT) with the
      participation of University Research Institutes and small/medium Italian enterprises.

      The general objective of the Project is to promote the collaboration between the best
      scientific research, both epidemiological and experimental, and the most advanced
      technologies to develop fortified foods that meeting the specific nutritional requirements of
      adult consumers. This objective will be achieved by the nutritional improvement of primary
      production, the development of innovative functional foods at high added value, in addition
      to traditional products functionalized, which are peculiar of the Italian local districts.
    

Detailed description: 
      Sleep disorders and, in particular, insomnia, are quite common conditions in over 55
      population, especially among women. Insomnia becomes a chronic pathology when the difficulty
      in initiating or maintaining sleep occurs more times a week for several months and is
      associated to a constant feeling of fatigue, concentration problems, mood disorders and
      social and family troubles severely impairing the quality of life. In according to the sleep
      hygiene guidelines, the therapeutic treatments for insomnia include drugs (benzodiazepines,
      non-benzodiazepines, antidepressants) with often not fully satisfactory results for the
      patient and entailing a series of side effects, such as daytime sleepiness, lack of attention
      and energy in addition to mental confusion. Recently, some researches in neurological field
      have shown that disorders affecting central nervous system, as well as sleep and circadian
      rhythm disruption, can be associated to specific alteration of the gut microbiota. The
      enteric nervous system has been referred to as a "second brain" able to interact with the
      central nervous system impinging upon higher cognitive functions through a bidirectional
      communication system known as gut-brain axis. The gut microflora plays a crucial role in
      gut-brain axis, modulating stress response through the Hypothalamic-Pituitary-Adrenal axis
      and thus influencing memory, mood, cognition and sleep architecture. Therefore, a
      non-pharmacological intervention aimed to improve gut microbiota and the inflammatory bowel
      conditions could be an effective strategy to counteract insomnia. In the framework of Pros.IT
      project, the Granarolo S.p.A. in collaboration with the University of Bologna has developed a
      milk enriched with different micronutrients (vitamins, ω-3 fatty acids, prebiotics, curcumin)
      and "infant-type" probiotics isolated from human milk and endowed with immunomodulating
      activity. This supplementation should improve the overall health status, and in particular
      the plant extracts, prebiotics and probiotics with anti-inflammatory and immunomodulatory
      activities should ameliorate significantly sleep quality and stress perception through the
      modulation of gut microbiota and gut-brain axis.

      The main goal of this study is to evaluate the effect of the administration of a functional
      milk reinforced with probiotics (250ml/die), vitamins and other micronutrients on sleep of
      patients suffering from chronic insomnia. An objective assessment it requires a value at
      least higher than 3% of increase of the sleep efficiency, since the 3% is the percentage of
      improvement recognized to the common drugs against insomnia. The study is randomized,
      double-blind, placebo-controlled trial.
    

Intervention name(s): Fortified milk; Placebo milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose <0.01%), enriched in whey protein (5%) and calcium (0.24%), supplemented with unsaturated fatty acids omega-3 (DHA + EPA), vitamins (D, B12, B6, B9, E, C), prebiotics (FOS) and phyto curcuminoids (sunflower lecithin). Milk had to be associated with a packet of lyophilized and concentrated probiotics (Bifidobacteria infant-type and / or Lactobacilli), at the time of consumption. Milk and probiotics had been produced or supplied by Granarolo s.p.a.; Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose <0.01%) with standard proteins of milk (3.1%) and color additive "quantum satis". Milk had to be associated with a packet of maltodextrin "Food Grade", at the time of consumption. Milk and maltodextrin had been produced or supplied by Granarolo s.p.a.
Other intervention name(s): golden milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: golden milk, insomnia, gut-brain axis